Multimodal Chronic Pain Therapy for Adults via Smartphone: Randomized Controlled Clinical Trial

Background Combination therapies delivered remotely via the internet or mobile devices are increasingly being used to improve and promote the self-management of chronic conditions. However, little is known regarding the long-term effects of these interventions. Objective The aim of this study is to evaluate the effectiveness of a multimodal intervention program that measures associated variables such as catastrophizing, pain acceptance, and quality of life using a mobile device in people with chronic pain in an outpatient setting. Methods A randomized controlled clinical trial was performed using parallel treatment groups. A total of 209 patients with chronic musculoskeletal pain were randomly assigned to one of the two study arms. The intervention group received a standard web-based psychosocial therapy-type program of activities through a smartphone for 6 weeks. The control group only had access to the Find out more section of the app, which contained audiovisual material for pain management based on a self-help approach. The primary outcome was catastrophizing measured using the Pain Catastrophizing Scale (PCS). Secondary outcomes were pain acceptance measured using the Chronic Pain Acceptance Questionnaire and health-related quality of life measured using the EuroQol Visual Analogue Scale. Assessments were conducted at baseline (T1), after treatment (T2), and at the 3-month follow-up (T3). The variations between the different phases were assessed using the percentage change rescaled with log base 2. The Cohen d was calculated based on the results of the linear mixed model. The investigators of the study who evaluated the results were not involved in patient recruitment and were blinded to the group assignment. Results Positive effects were found in the intervention group (T2–T1) in catastrophizing between the baseline and posttreatment phases (P<.001) and in helplessness (−0.72 vs 0.1; P=.002), rumination (−1.59 vs −0.53; P<.001), acceptance (0.38 vs 0.05; P=.001), and quality of life (0.43 vs −0.01; P=.002), although no significant changes were found for magnification (0.2 vs 0.77; P=.14) and satisfaction with health (0.25 vs −0.27; P=.13). Three months after treatment, significant differences were observed in the intervention group for the outcome variable of catastrophizing (PCS; −0.59 vs 0.2; P=.006) and the PCS subscales of helplessness (−0.65 vs 0.01; P=.07), rumination (1.23 vs −0.59; P=.04), and magnification (0.1 vs 0.86; P=.02). Conclusions The results of our study suggest that app-based mobile multidimensional treatments for adults with chronic pain improve catastrophizing, quality of life, and psychological flexibility immediately after treatment and that the effects are maintained for the primary outcome of catastrophizing for at least 3 months following treatment. Moreover, they promote self-management and can be used to complement face-to-face pain treatments. Trial Registration ClinicalTrials.gov NCT04509154; https://clinicaltrials.gov/ct2/show/NCT04509154

Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) JMIR ms#36114 1a) Does your paper address CONSORT item 1a? * Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if ouine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.

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Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes, "smart-phone" is included in the title

1a-ii) Non-web-based components or impo5ant co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support"). Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."with telephone support" 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial

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Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes " Chronic Pain Adults" is the target patient population, and is included in the title. Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. See ABSTRACT in ms for further information. "fully automated". The intervention group received a standard,(video, audio, text) psychosocial therapy-type program of activities through a smartphone for 6 weeks. The control group only had access to the "Find out more" section of the application, which contains audiovisual material for pain management based on a self-help approach. Comparator: "publicly available websites" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. ouine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional ouine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. "Most outcome data are collected online."; "Blinding is implemented during data analysis and in patient recruitment" 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

INTRODUCTION
Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. Results section in the abstract reports the number of participants who took part in the study as well as study outcomes (with reported signiPcance "p" ) (for further information see ABSTRACT in ms).

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. Conclusion for the abstract reports outcome of study: (for further information see ABSTRACT in ms). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."There is a large body of research on multi-disciplinary treatment programs for adults with chronic pain that has reviewed the clinical evidence and effectiveness of treatments for pain, as well as the cost-effectiveness of these programs in outpatient settings".(for further information see INTRODUCTION in ms).
Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. Hypotheses and objetives are mentioned 2/3/22 21&23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. "A randomized controlled clinical trial was performed using parallel treatment groups". The allocation ratio is stated in the RANDOMIZATION AND ALLOCATION section. "Block randomization was used to ensure similar numbers of subjects in each group and intervention phase (Fig. 1).Assessed for eligibility (n=297).Randomized (n=209) Received allocated intervention (n=98) and control (n=96)." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study There were no changes to the methodology after the trial commenced.

3b-i) Bug ^xes, Downtimes, Content Changes
Bug Pxes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug Pxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have invuenced study design such as staff changes, system failures/downtimes, etc.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study There were no 'bugs, downtimes or content changes' that inuuences study design.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."Patients ≥ 18 years of age with pain of any location". "Pain with a duration of ≥3 months". "Pain with an intensity of ≥4 on the Visual Numerical Scale (VNS)". "Presenting one of the following characteristics: continuous pain, intermittent pain ≥5 days a week". "Able to use a smartphone". "Not participating in another research project".

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariPed. Does your paper address subitem 4a-i?

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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study The participants used COMPUTER to send the questionnaires via email. Participants did not use a computer or the internet for others aspect of this study.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. ouine), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conPrmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."We explain in the Randomization and Blinding and Treatment Procedures,this intervention is "fully-automated" Block randomization with a block size of 4 was used. The only stratiPcation criterion was the reference health center of the patient in question. An automated recruitment form hosted on the REDCap platform of the Maimonides Biomedical Research Institute of Cordoba (IMIBIC) was used to randomize the patients by simply clicking a button. The data were transferred and recorded in an electronic notebook using the Data Entry Manager (CDR) system. The statistician, the principal investigator and the co-investigators of the study who evaluated the results were not involved in patient recruitment and were blinded to group assignment. The twenty-two recruiters from the 11 primary care health centers of the Cordoba South Health District in 2019 who recruited the patients in 2019 were also responsible for randomizing the patients (i.e., clicking the button on the automated recruitment form) and were not blinded" 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. (for further information see PARTICIPANTS under Methods in ms).

Does your paper address CONSORT subitem 4b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."A between-subjects experimental study was conducted at the 11 primary care health centers of the Cordoba South Health District " 4b-i) Repo5 if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise. 5) The interventions for each group with suWcient details to allow replication, including how and when they were actually administered Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. We explain in the PROCEDURES section that to assess the treatments, self-reported questionnaires were sent to the participants by email and collected at three time points: at admission to the program (T1), at week six of the intervention (T2) and three months after the intervention (T3). The participants completed all three questionnaires at home and returned them by email.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Ajliations were clearly displayed to participant in participant information sheet (for further information see under Methods in ms).

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Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. See ACKNOWLEDGEMENTS at the end of the ms for further information.

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."To develop the contents of the multimodal treatment for the mobile device application (app), a systematized literature review was carried out in a Prst phase following the Scottish Intercollegiate Guideline Network (SIGN) guidelines. The second part of our study consisted in the prioritization of self-management recommendations for chronic pain selected from the reviewed literature using a participatory approach. SpeciPcally, we designed a multimodal intervention protocol combining physical exercise, psychoeducational therapy, health assets and pharmacological treatment, which was delivered using a mobile device. The effectiveness of the intervention was subsequently evaluated by means of a clinical trial[39"].

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial.
Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study There were no revisions or updating the study methodology during in evaluation process.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study The research methodology and monitoring of data collection overseen by the principal investigator (PI) Yolanda Morcillo. All condition checked at baseline and half way point by Dr Antonio Jose Sanchez Guarnido.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing dowcha5s of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing vowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiPc reporting. Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. Methodology of the experiment clearly explained (for further information see EXPERIMENTAL DESIGN and PROCEDURE under Methods in ms).

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study (https://apps.apple.com/es/app/no-más-dolor-edcno/id1458096026).

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speciPc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).

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Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. Access to the intervention is presented in the PROCEDURES section:"At the group meeting, the patients who agreed to participate voluntarily in the study were informed that they would receive instructions by email on how to download the mobile application with the contents of the treatment. The patients were also informed that if they were selected to participate in the intervention group, the treatment would last from 6 to 8 weeks. The control group would only have access to the "Find out more" section of the application, which contains audiovisual materials for pain management from a self-help approach, such as information on the origin of chronic pain and advice for pain treatment and relaxation".

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Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes.The intervention consisted of the implementation of a "program of standard", psychosocial therapy activities. The pain management application enables "automatic monitoring, skills training, social support, education, goal setting, and the achievement of four components: psychological wellness, exercise, pharmacological treatment and health assets." Each week, the participants received three activities for each of the above components via the "NO + pain" app until completing the six weeks of treatment. All the activities are designed to be done weekly except for the walking challenge, which is done daily. The Prst time a participant completes an activity, they are awarded a star. Participants can do the proposed activity as many times as they like but no more rewards are given until the following week. The more activities they complete, the more stars they are awarded and the higher the percentage of goals reached by the patients each week "(Appendix 1)". The application also has a "Consultation" section with a contact form where the participants can send any questions or comments. The form is then sent by email to the researchers so that they can respond to the inquiries.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. The intervention group received the treatment via their smartphones (APP No+ PAIN)for a period of six weeks after completing the two face-to-face sessions. Appendix1. Key contents to complete the intervention. (for further information see PROCEDURES under Methods in ms).

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. Experiment involved an interaction between and human participant and a App. A human researcher was present to provide instruction, administer measures and answer questions. We state that the intervention is fully-automated..

5-xi) Repo5 any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

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Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study No prompts reminders were used in this study.

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Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study No co-interventions were used for this study. Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."Primary Outcome: Catastrophizing" The descriptive results for differences between the control and intervention groups regarding measures of catastrophizing at baseline, upon completion of the treatment and during follow-up are presented in Table 2. Between-group variations over time for the primary outcome variable are presented in "Secondary Outcomes" Table 5 shows the results for the variables acceptance (CPAQ), quality of life (EQ-5D) and overall health state (EQ-VAS), while
Copy and paste relevant sections from manuscript text Yes.The application also has a "Consultation" section with a contact form where the participants can send any questions or comments. The form is then sent by email to the researchers so that they can respond to the inquiries.
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study No changes were made to the trial after commencement

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Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes.." Accepting an alpha error of 0.05 and a beta error of 0.2 (statistical power of 80%) in a two-tailed test and estimating 15% loss to follow-up, n = 296 is required to detect a statistically signiPcant difference between two means at 3 points in our outcome variable with an estimated standard deviation of 12". To obtain different trajectories for each group (experimental vs. control) over time, we included the "intercept and slope effect as random effects"; and "time, group and the interaction term (group × time) as Pxed effects". The" variance-covariance" structure was Pxed to an unstructured matrix and the random effects and error terms were assumed to have a normal distribution. Furthermore, "Cohen's d" was calculated based on the results of the "linear mixed model" (Cohen, 1988).The established level of statistical signiPcance was P < .05." 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study No interim analyses or stopping guidelines were applicable to this study.

Does your paper address CONSORT subitem 8a? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. "Block randomization with a block size of 4 was used. The only stratiPcation criterion was the reference health center of the patient in question. An automated recruitment form hosted on the REDCap platform of the Maimonides Biomedical Research Institute of Cordoba (IMIBIC) was used to randomize the patients by simply clicking a button. The data were transferred and recorded in an electronic notebook using the Data Entry Manager (CDR) system. The statistician, the principal investigator and the co-investigators of the study who evaluated the results were not involved in patient recruitment and were blinded to group assignment. 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled paQicipants, and who assigned paQicipants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes.Block randomization with a block size of 4 was used. The only stratiPcation criterion was the reference health center of the patient in question...(for further information see PROCEDURE under Methods in ms).
Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. "The assignment sent by the coordinating center in electronic list (.xls) format was uploaded in the RED CAP platform. The allocation sequence is concealed. Upon submission of the baseline questionnaire, the RED CAP platform sends an automated email of the assignment to the participant. This email includes the hyperlink and password to access the experimental app NO+PAIN , or to receive a different hyperlink to access the control of publicly available websites." 11a) If done, who was blinded aRer assignment to interventions (for example, paQicipants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. The co-investigators enrolled participants, and who assigned participants to interventions and were not blinded( (i.e., clicking the button on the automated recruitment form).

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any). Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes.The statistician, the principal investigator and the co-investigators of the study who evaluated the results were not involved in patient recruitment and were blinded to group assignment. The twenty-two recruiters from the 11 primary care health centers of the Cordoba South Health District in 2019 who recruited the patients in 2019 were also responsible for randomizing the patients (i.e., clicking the button on the automated recruitment form) and were not blinded.Participants unaware of condition they were randomised to.
11a-ii) Discuss e.g., whether pa5icipants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study "Participants were not aware of the differing conditions in the study or which condition they had been assigned too".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. "The App No+Pain was fully automated " (for further information see PROCEDURES under Methods in ms).
Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. All statistical methods used are outlined clearly in ms. e.g. "A descriptive analysis was performed for the quantitative variables with mean (M) and standard deviation (SD) and for the qualitative variables with recounts (n) and proportions (%). Goodness-of-Pt to a normal distribution was determined using the Shapiro-Wilk test and homogeneity of variance was assessed using Levene's test. ..." (for further information see Data Analysis in ms). subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with airition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).

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Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. "In the intervention group, 15 patients did not complete the intervention. The analysis was performed with patients who had completed all three questionnaires at baseline, upon completion of the intervention and three months after the intervention. Table 1 shows the demographic data and baseline characteristics of the sample by groups".

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study The descriptive results for differences between the control and intervention groups regarding measures of catastrophizing at baseline, upon completion of the treatment and during follow-up are presented in Table 2. Between-group variations over time for the primary outcome variable are presented in Table 3. Table 5 shows the results for the variables acceptance (CPAQ), quality of life (EQ-5D) and overall health state (EQ-VAS), while Table 6 shows variations over time for the secondary outcomes. Table 6 shows the Fisher-Freeman-Halton descriptive analysis of the proportion of participants with clinically signiPcant improvement immediately after treatment according to the EQ-5D subscale. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."Written informed consent was obtained immediately prior to the participant undertaking their interaction with the App". "All patients received a written invitation from their primary care physician or nurse to participate in the study. Two 8-hour face-to-face sessions were held at their reference health center led by one nurse and one primary care physician with experience in the follow-up of chronic pain patients. At the group meeting, the patients who agreed to participate voluntarily in the study were informed that they would receive instructions by email on how to download the mobile application with the contents of the treatment. The patients were also informed that if they were selected to participate in the intervention group, the treatment would last from 6 to 8 weeks. The control group would only have access to the "Find out more" section of the application, which contains audiovisual materials for pain management from a self-help approach, such as information on the origin of chronic pain and advice for pain treatment and relaxation".

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 2/3/22 21&23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Página 46 de 64 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full RESULTS 13a) For each group, the numbers of paQicipants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers peDorming the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions aRer randomisation, together with reasons Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study No safety or security measures were needed for this study because the APP used was harmless.
Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study "Numbers of participants who were randomly assigned". "Allocated to intervention( n=105), control (n=103). Received intended treatment (n= 98), control (n= 96), and were analysed for the primary outcome intervention (n= 56),control (n= 53)". Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT dow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."A total of 297 subjects (205 females and 92 males) were initially invited to participate in the study. Of these, one was excluded for not meeting the inclusion criteria, 78 because they did not attend the meeting and 20 who declined to participate. A total of 198 subjects (151 women and 47 men) were randomized to one of the two study arms (Fig. 1). After randomization, Pve subjects were excluded for declining to participate, dropping out before the intervention or because they did not know how to use the technologies. In the intervention group, 15 patients did not complete the intervention.

13b-i) Airition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other Pgures or tables demonstrating usage/dose/engagement.

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Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Pgure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes.Block randomization was used to ensure similar numbers of subjects in each group and intervention phase. Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."Recruitment took place in June of 2019".

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., signiPcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources"

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Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study N/A -no secular events occurred.

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualiFcation, expeGise, etc.) and centers (volume) in each group subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study The trial ended when sujcient participants had been recruited and been through study procedures.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes. Table 2 shows the demographic data and baseline characteristics of the sample by groups.

15-i) Repo5 demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.

16) For each group, number of paQicipants (denominator) included in each analysis and whether the analysis was by original assigned groups
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Not known. No digital divide issues

16-i) Repo5 multiple "denominators" and provide de^nitions
Report multiple "denominators" and provide dePnitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speciPc pre-dePned time points of interest (in absolute and relative numbers per group). Always clearly dePne "use" of the intervention.

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Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes.Is included in the section Results (table 3,4,6 to 8). 17a) For each primary and secondary outcome, results for each group, and the estimated egect size and its precision (such as 95% con6dence interval)

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes.Is included in the section Results Primary analysis intent-to-treat (table 3 to 5), secondary analyses (table 6,7).
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Effect size and signiPcance reported for relevant outcomes. eg...."Additionally, the variations between the different phases were assessed by means of the percentage change rescaled with log base 2"....(for further information see RESULTS section in ms).
subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative egect sizes is recommended 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational dePnitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is dePned (e.g., timeout after idle time) [1] (report under item 6a).

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Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study This study did not use metrics of use and intensity as it was not relevant to the conditions analysed.
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes.Control group used for this study. Effect sizes reported for relevant outcomes. (for further information see RESULTS in ms).
18) Results of any other analyses peiormed, including subgroup analyses and adjusted analyses, distinguishing pre-speci6ed from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes, "A linear mixed effects model [56,57] was subsequently used to assess changes over time for the repeated measurements of the pain questionnaire scores at three time points between the control group and treatment group. Linear mixed effects models account for variability between subjects and variability between repeated measurements in the same subject simultaneously. To obtain different trajectories for each group (experimental vs. control) over time, we included the intercept and slope effect as random effects; and time, group and the interaction term (group × time) as Pxed effects. The variance-covariance structure was Pxed to an unstructured matrix and the random effects and error terms were assumed to have a normal distribution".

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

19) All impoQant harms or unintended egects in each group
(for speciFc guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study No subgroup analysis was used.
Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study No harms or unintended effects.

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2]. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Firstly, we developed a multimodal program involving a variety of therapeutic activities that could be standardized and used in the future for other patients with chronic pain. An encouraging Pnding in this line was that the benePts of the treatment were largely maintained at follow-up, which may suggest that these interventions lead to the acquisition of skills that result in behavioral change, at least in the medium term. Secondly, ICTs were used in combination with pharmacological and non-pharmacological therapeutic treatments in the outpatient setting to evaluate their impact on pain catastrophizing, pain acceptance and quality of life. Thirdly, the fact that patients did the programmed activities in their natural environment is likely to promote self-e}cacy, thus supporting the importance of the self-management component in interventions of this type [26].
22-i) Restate study questions and summarize the answers suggested by the data, sta5ing with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study "In future research, more attention should also be given to the participants' gender as this could have affected our Pndings. It is well known that gender is strongly related to access to care and treatment response and that while many patients who suffer pain from are women, many stigmas are associated with pain in men. Therefore, it is important that we gain a better understanding of the role of gender in healthcare access, as well as gender biases in diagnoses, patient-professional interactions and treatment. Further lines of research could improve the e}cacy of multimodal chronic pain interventions based on new technologies, such as the rePnement of treatments, the identiPcation of moderating factors that might invuence psychosocial variables and their association with treatment adherence. To evaluate which groups of patients are more competent to selfmanage a technology-based multimodal intervention would have been ideal. In the same vein, it is also worth mentioning that in our study we have not speciPcally assessed satisfaction in relation to the use of technologies and this could be a promising line for future research".

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

21) Generalisability (external validity, applicability) of the trial 6ndings
NPT: External validity of the trial Fndings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes."The low response rate of the self-reported questionnaires sent via email". we used a "multimodal therapy", "we cannot really know the effect of each individual intervention on the outcomes" "The electronic records on participants' access to and completion of the activities were not analyzed, we do know that 85% completed the intervention program".

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Borrar selección Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study "A large number of studies have been conducted on ICT-based interventions to promote selfmangement in people with chronic pain [77][78][79], and there is evidence of high ICT acceptance and satisfaction [74,75]. Indeed, because technologies can assist and support people in their daily lives and at any time of the day[33], smartphones have become a very effective healthcare tool. In our smartphone app, we have selected evidence-based activities to address the various dimensions of chronic pain. The activities are easily reproducible in many environments and healthcare Pelds and can serve as complementary therapies for the comprehensive treatment of people with persistent pain. Nonetheless, it should be noted that self-mangement for pain management is only effective when implemented from a multidisciplinary approach, as treatment response is individual and there is no single approach that is benePcial for all patients with chronic pain. Therefore, for smartphonebased applications to be successful in promoting the self-management of chronic pain, we believe they should include self-monitoring, goal setting, skills training, social support and educational components. Moreover, many of these applications appear to have been developed without the involvement of patients and health care professionals and, to the best our knowledge, few have been tested in randomized trials to evaluate their impact on health".

21-ii) Discuss if there were elements in the RCT that would be diUerent in a routine application seiing
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Borrar selección 2/3/22 21&23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study N/A -As this is novel research in social , there is no 'routine application'.
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Trial Registration: ClinicalTrial.gov (NCT04509154) https://clinicaltrials.gov/ct2/show/NCT04509154 Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Can contact researchers for full trial protocol. Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study Yes.This study has been funded by the Regional Ministry of Health by Resolution of 18 May 2017 with the collaboration of the Biomedical Research Foundation of Cordoba (IMIBIC).

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (Pnancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

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Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brievy explain why the item is not applicable/relevant for your study The authors declare no convicts of interest. As a result of using this checklist, did you make changes in your manuscript? * What were the most impo5ant changes you made as a result of using this checklist?

Details of the methods were added
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * More than 20 hours INCLUDING making changes in the manuscript As a result of using this checklist, do you think your manuscript has improved? * 2/3/22 21&23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form STOP -Save this form as PDF before you click submit To generate a record that you Flled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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