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Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches.
This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]).
A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months’ follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages.
A moderate decrease was detected in PHQ-9 scores from HLP (β=–3.05;
The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions.
ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279
RR2-10.1186/s12888-015-0475-0
Depression represents a significant personal, economic, and societal burden [
Multiple and complex facilitators and barriers to treatment have been described [
Most of the internet interventions aiming at the treatment of depression are based on CBT. Previous findings for other forms of face-to face psychotherapy suggest that there is no
In a previous study, our group shows the efficacy of an internet intervention for depression in primary care (smiling is fun) [
Evidence of the benefits for treating depression of positive psychology, mindfulness, and lifestyle habits delivered using internet is growing as a result of increase in research studies over the last 10 years [
Considering the scarcity of these studies and the fact that low-intensity, internet-based psychological interventions could be an efficacious and cost-effective therapeutic option for the treatment of depression, the aim of this study was to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (psychoeducational program for the promotion of a healthy lifestyle (HLP), psychological intervention for the promotion of positive affect (PAPP), and brief intervention based on mindfulness [MP]) compared with a control condition.
This study was a multicenter, 4-arm, parallel randomized controlled trial. Adults with depressive symptoms in primary care were randomly assigned to one of the following groups: (1) HLP + improved treatment as usual (iTAU), (2) PAPP + iTAU, (3) MP + iTAU, or (4) iTAU.
Trial registration number of this study was ISRCTN82388279. Research protocol of the study has been described elsewhere [
We recruited patients with major depression or dysthymia, older than 18 years, able to understand and read Spanish, with mild or moderate depression according to the Patient Health Questionnaire-9 (PHQ-9; 5-9: mild depression; 10-14: moderate depression) [
Participants were recruited in primary care settings, between March 2015 and March 2016, in the Spanish regions of Aragon, Andalusia, and the Balearic Islands. When the general practitioner identifies a potential participant during a routine visit, he or she explained to the patient the characteristics of the study. When the patient was interested in participating, he or she signed an informed consent form and the general practitioner filled a referral form describing the sociodemographic characteristics of the patient and a checklist for inclusion and exclusion criteria and gave him or her the patient’s information sheet and a handout describing the study. The general practitioner sent these documents by fax to the local researcher. Participants were interviewed in the next 3 days by the researcher, which administered psychological assessment instruments related with inclusion and exclusion criteria by phone. Included participants were randomized to 1 of the 4 groups by an independent researcher. Patient safety was systematically monitored. The Ethical Review Board of the regional health authority approved the study (Ref: IB 2144/13PI).
The sequence was concealed until interventions were assigned. Participants agreed to participate before the random allocation without knowing which treatment they were being allocated to. Study personnel conducting psychological assessment were masked to participants’ treatment conditions. The researcher that administered baseline assessments was unaware of the treatment group to which the participant belonged. This researcher was different from the one that administered the questionnaires over the study. General practitioners were also unaware, as far as possible, of the arm to which each patient had been randomized, as their treatment needed to be exclusively based on the recommendations of the treatment of depression guidelines.
Follow-up data collection took place between April 2015 and June 2017. Participants were assessed on web at pretreatment (time 1), posttreatment (time 2), and 6- (time 3) and 12- (time 4) month posttreatment assessments. The web-based platform hosted the questionnaires. Participants were sent an email with a link to that platform. No other protocols were used to increase compliance with the research data collection, but a phone call was made before each wave assessment to increase response rates.
All the patients included in the study (irrespective of the treatment group randomly assigned) received iTAU. This treatment was provided by their general practitioners, who had previously received a training program to update their knowledge on how to diagnose and treat depression in primary care and optimized by the recommendations based on the Spanish Guide for the Treatment of Depression in Primary Care [
All interventions (except iTAU) were composed of one face-to-face group session and 4 web-based, individual, and interactive therapeutic modules.
The face-to-face session, which took place in primary care centers, involved up to 5 patients and was 90 min long. The aim of this session was to explain the program structure and main components of treatment and to motivate participants for change.
The web-based therapeutic modules are oriented to work on different psychological techniques, and the duration of each module is approximately between 40 and 60 min. All modules include an explanation of the module contents, check questions to test if they understand the contents, and exercises to practice the techniques. These modules are sequential, to move step by step, throughout the program. However, users can review the module contents once they are finished. Although the duration of the program can vary among users, it is estimated that for most people, it lasted between 4 and 8 weeks. Regarding the therapeutic content, all intervention groups are composed of 4 intervention modules based on different psychological techniques, as shown in
To maximize adherence, participants received 2 weekly automated mobile phone messages, encouraging them to proceed with the program and reminding them of the importance of doing the tasks in each module. If participants did not access the program for a week, they received an automated email encouraging them to continue with the modules. Furthermore, the program also offers continued feedback to users through the assessment tools showing them their progress throughout the entire treatment process. All groups of patients received a participant manual with information about the technical aspects of the web-based program.
Intervention modules and main objectives.
Intervention and modules | Main objective | |
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Beginning of a lifestyle change | To teach the importance of healthy lifestyle to improve emotional health and general well-being and to give structured hygienic-dietary recommendations. |
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Physical activity. Learning to move on | To give information about the most recommended exercises to improve mood, and to train the patient in learning procedures to increase motivation, to start being more active, and to maintain this physical activity regularly. |
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Diet. Learning to eat | To teach the importance of diet to achieve a good physical and mental health, and the role of the Mediterranean diet in the prevention and treatment of depression. |
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Sleep. The importance of good sleep | To understand the relationship between sleep and general health. |
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Learning to live | To teach the importance of establishing and maintaining an adequate activity level and the relevance of choosing activities that are significant, with a personal meaning for the individual. |
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Learning to enjoy | To give education about the effect of positive emotions and to train the patient in learning procedures to increase the likelihood of experiencing positive emotions, promoting the occurrence of pleasant activities to learn to enjoy the present moment. |
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Accepting to life | To train the patient in focusing on positive emotions related with the past (such as gratitude) or the future (such as optimism). |
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Living and learning | To train the patient in understanding life as a continuous process of learning and personal growth, emphasizing the training in strategies to promote psychological strengths, resilience, and meaningful goals linked to important values. |
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Getting to know mindfulness | To show what mindfulness is, prejudices about it, the inattention problem, and some of its main benefits and recommendations to practice it. |
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Establishing formal and informal practices | To teach the importance of the establishment not only of formal but also of informal practice. |
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Through management, body scan practice and values | To help people to see the importance of values to keep a regular mindfulness practice. |
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Self-compassion. Integrating mindfulness in everyday life | To establish a regular practice of mindfulness to be indefinitely kept. |
We gathered sociodemographic data such as gender, age, place of residence, family status, living with family or alone, level of studies, work status, and income level according to national minimum wage (NMW) as well as clinical variables such as taking psychopharmacological medication (yes vs no) and the number of general practitioners visits in the previous 12 months.
The Spanish version of PHQ-9 [
Secondary outcomes included the visual analog scale (VAS) of the EuroQol (
The VAS is a vertical line on which the best and worst possible health states are scored, 100 or 0, respectively. The SF-12 scoring algorithm yields a physical and mental component scale, and both were used as continuous variables applying Spanish norms. The PANAS evaluates 2 independent dimensions: positive affect and negative affect and were used as continuous variables.
Required sample size was 240 participants, 60 participants in each condition [
First, demographic and outcome variables were characterized through descriptive exploratory analysis. Database scrutiny revealed increasing percentages of whole wave missingness in primary and secondary outcome variables along the follow-up. Missingness effects were, thereafter, assessed through sensitivity analyses for demographic variables, intervention groups, and baseline outcomes, considering dropout as study abandonment, with or without subject return, at any assessment period. Although an association between collected variables and study attrition had been detected, no association was reported between outcome values and follow-up missingness; hence, missing at random was assumed for primary and secondary outcome variables. Finally, we implemented Multiple Imputation with Chained Equations (MICE) to replace the outcome missing values, performing 100 imputation models with 100 iterations per model.
We conducted paired
A total of 221 recruited participants met inclusion criteria and agreed to participate after baseline assessments (
Attrition rates increased significantly as study went forward: primary outcome PHQ-9 data were collected for the 72.4% (160/221) of participants at time 1, 57.5% (127/221) at time 2, 46.2% (102/221) at time 3, and 43.9% (97/221) at time 4. Missingness analysis does not report outcome baseline significant differences between dropout and nondropout groups. Conversely, differences in missingness were found between intervention groups, with 28% (15/54) in HLP and 24% (13/54) in MP presenting significative less dropout subjects (
Flow diagram.
Baseline characteristics of participants between intervention groups.
Intervention characteristics and measures | Intervention groups | |||||
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iTAUa | HLPb | MPc | PAPPd | ||
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Age, mean (SD) | 44.54 (16.10) | 44.67 (9.98) | 47.50 (13.09) | 44.53 (10.23) | |
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Sex (female), n (%) | 41 (72) | 40 (74) | 47 (87) | 44 (79) | |
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Married, n (%) | 24 (52) | 23 (47) | 27 (59) | 31 (62) | |
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Living with family or couple, n (%) | 38 (83) | 36 (75) | 34 (76) | 44 (88) | |
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High education, n (%) | 14 (33) | 18 (45) | 17 (43) | 19 (40) | |
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20 (44) | 22 (47) | 17 (40) | 25 (50) | |
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<1 NMWe | 6 (19) | 10 (30) | 7 (23) | 13 (33) |
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1-2 NMW | 16 (52) | 16 (48) | 7 (23) | 14 (36) |
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2-4 NMW | 8 (26) | 7 (21) | 12 (40) | 12 (31) |
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>4 NMW | 1 (3) | 0 (0) | 4 (13) | 0 (0) |
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PHQ-9f, mean (SD); median (IQR) | 12.46 (2.10); 13.0 (11-14) | 12.57 (2.46); 13.5 (11-14) | 12.67 (2.56); 13.0 (11-14) | 12.63 (2.03); 13.0 (11.5-14) |
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Physical SF-12g, mean (SD); median (IQR) | 43.06 (11.03); 41.38 (35.49-51.89) | 42.16 (10.66); 39.84 (35.07-52.02) | 42.52 (9.75); 42.11 (35.58-48.27) | 45.17 (13.54); 45.74 (35.04-55.65) |
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Mental SF-12, mean (SD); median (IQR) | 26.75 (9.62); 24.54 (20.97-30.58) | 27.59 (9.61); 25.98 (21.47-32.75) | 26.96 (10.86); 24.51 (20.93-28.66) | 26.22 (9.97); 23.79 (19.77-29.85) |
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VAS EuroQolh, mean (SD); median (IQR) | 51.60 (17.95); 50 (40-60) | 52.22 (21.63); 50 (30-70) | 48.91 (26.01); 50 (30-70) | 49.00 (19.05); 50 (40-60) |
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Overall PHIi index, mean (SD); median (IQR) | 4.3 (1.86); 4.33 (2.92-5.42) | 4.4 (1.95); 4.42 (3-5.42) | 4.32 (1.83); 4.42 (2.96-5.17) | 4.25 (1.98); 4.58 (2.83-5.42) |
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Positive affect PANASj, mean (SD); median (IQR) | 18.56 (6.43); 17 (14-23) | 19.04 (6.94); 18 (13-25) | 19.48 (6.60); 18 (15-22) | 18.09 (6.00); 17 (13-22) |
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Negative affect PANAS, mean (SD); median (IQR) | 28.27 (8.45); 27 (22-34) | 28.91 (8.34); 29 (23-35) | 27.89 (8.07); 27 (22-32.75) | 29.46 (8.79); 27 (23-35.5) |
aiTAU: improved treatment as usual.
bHLP: healthy lifestyle program.
cMP: mindfulness program.
dPAPP: positive affect promotion program.
eNMW: national minimum wage.
fPHQ-9: Patient Health Questionnaire-9 items.
gSF-12: 12-item Short-Form Health Survey.
hVAS EuroQol: visual analog scale of the EuroQol.
iPHI: Pemberton Happiness Index.
jPANAS: Positive and Negative Affect Schedule.
All our primary and secondary results were extracted from databases with high rates of attrition, 44.7% (395/884), which were thereafter imputed. Thus, the following results should be considered more as suggestive hypothesis rather than empirical statements. To this extent, we found significant decreases of PHQ-9 scores (
Primary outcome analysis with imputed data (N=221): intervention comparisons along the follow-up.
Primary outcome | Time 1 (pretreatment) | Time 2 (posttreatment) | Time 3 (6 months) | Time 4 (12 months) | ||||||
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gd | 0.25 | –0.50 | –0.22 | –0.06 | ||||
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.20 |
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.23 | .73 | |||||
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βf (95% CI) | 1.41 (–0.75 to 3.57) | –3.05 (–5.43 to –0.68) | –1.52 (–3.98 to 0.95) | –0.40 (–2.71 to 1.91) | ||||
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g | –0.17 | 0.47 | 0.24 | –0.01 | ||||
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.36 | . |
.18 | .96 | |||||
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β (95% CI) | 1.00 (–1.16 to 3.16) | –3.00 (–5.37 to –0.63) | –1.68 (–4.15 to 0.78) | 0.06 (–2.25 to 2.37) | ||||
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g | –0.23 | 0.23 | 0.31 | 0.01 | ||||
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.20 | .22 | .10 | .99 | |||||
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β (95% CI) | 1.40 (–0.74 to 3.54) | –1.46 (–3.81 to 0.89) | –2.08 (–4.52 to 0.37) | –0.02 (–2.31 to 2.27) | ||||
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g | 0.07 | -0.01 | 0.03 | –0.07 | ||||
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.71 | .96 | .90 | .70 | |||||
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β (95% CI) | 0.41 (–1.78 to 2.57) | –0.06 (–2.46 to 2.35) | 0.17 (–2.33 to 2.67) | –0.46 (–2.81 to 1.88) | ||||
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g | 0.00 | –0.25 | 0.09 | –0.06 | ||||
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.99 | .19 | .66 | .75 | |||||
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β (95% CI) | 0.01 (–2.16 to 2.18) | –1.59 (–3.97 to 0.79) | 0.56 (–1.92 to 3.04) | –0.38 (–2.70 to 1.94) | ||||
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g | –0.07 | –0.23 | 0.06 | 0.01 | ||||
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.72 | .21 | .76 | .94 | |||||
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β (95% CI) | 0.40 (–1.77 to 2.57) | 1.53 (–0.85 to 3.92) | –0.39 (–2.87 to 2.08) | –0.08 (–2.41 to 2.24) |
aPHQ-9: Patient Health Questionnaire-9 items.
biTAU: improved treatment as usual.
cHLP: healthy lifestyle program.
dg: Hedge’s effect size measure
eStatistically significant values (
fβ: regression coefficient.
gMP: mindfulness program.
hPAPP: positive affect promotion program.
Dose-response in imputed primary outcome at posttreatment and along the follow-up.
Interventions | Pretreatment to posttreatment | Pretreatment to posttreatment | Pretreatment to posttreatment | ||||||||||
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βa (95% CI) | β (95% CI) | β (95% CI) | ||||||||||
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CACEc analysisd | –3.32 (4.43 to –2.21) |
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–0.51 (2.03 to 1.02) | .74 | –1.03 (2.61 to 0.56) | .52 | ||||||
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Effect per session | –0.28 (0.34 to –0.21) |
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–0.17 (0.25 to –0.09) |
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–0.06 (0.13 to 0.02) | .45 | ||||||
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CACE analysis | 0.93 (0.71 to 2.57) | .57 | 1.01 (0.72 to 2.74) | .56 | 1.13 (0.5 to 2.76) | .49 | ||||||
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Effect per session | 0.26 (0.22 to 0.74) | .59 | –0.17 (0.25 to –0.09) |
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–0.06 (0.13 to 0.02) | .45 | ||||||
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CACE analysis | 0.24 (1.30 to 1.78) | .88 | 0.96 (0.66 to 2.57) | .56 | 0.30 (1.24 to 1.84) | .85 | ||||||
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Effect per session | –0.28 (0.34 to –0.21) | . |
–0.17 (0.25 to –0.09) |
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–0.06 (0.13 to 0.02) | .45 | ||||||
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CACE analysis | –2.11 (2.86 to –1.36) |
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–0.49 (1.37 to 0.4) | .58 | –0.22 (1.04 to 0.6) | .79 | ||||||
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Effect per session | –0.28 (0.34 to –0.21) |
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–0.17 (0.25 to –0.09) |
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–0.06 (0.13 to 0.02) | .45 |
aβ: regression coefficients.
bHLP: healthy lifestyle program.
cCACE: Complier Average Causal Effect.
dCompliance as attendance >4 modules.
eStatistically significant values (
fMP: mindfulness program.
gPAPP: positive affect promotion program..
Imputed Mental and Physical SF-12 scores significantly increased in all intervention groups (iTAU included) from pretreatment to posttreatment (Mental SF-12:
Although EuroQol (VAS) significant differences were detected from pretreatment to 6 months (
Short-Form Health Survey-12 (Mental and Physical) outcome analysis with imputed data (N=221): intervention comparisons along the follow-up.
Secondary outcomes | Time 1 (pretreatment) | Time 2 (posttreatment) | Time 3 (6 months) | Time 4 (12 months) | |||||
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gd | –0.06 | –0.42 | –0.11 | 0.01 | |||
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.73 | . |
.53 | .98 | ||||
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βf (95% CI) | –0.63 (–4.25 to 2.99) | –5.32 (–9.91 to –0.72) | –1.53 (–6.30 to 3.23) | –0.05 (–5.04 to 4.93) | |||
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g | 0.14 | 0.16 | 0.01 | –0.05 | |||
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.46 | .38 | .94 | .81 | ||||
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β (95% CI) | –1.37 (–4.99 to 2.24) | –2.06 (–6.66 to 2.53) | –0.18 (–4.95 to 4.58) | 0.62 (–4.36 to 5.61) | |||
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g | 0.15 | 0.67 | 0.22 | 0.24 | |||
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.45 |
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.28 | .20 | ||||
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β (95% CI) | –1.37 (–4.96 to 2.21) | –7.72 (–12.27 to –3.16) | –2.61 (–7.33 to 2.11) | –3.2 (–8.14 to 1.74) | |||
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g | 0.07 | –0.25 | –0.1 | –0.05 | |||
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.69 | .17 | .58 | .79 | ||||
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β (95% CI) | –0.74 (–4.41 to 2.93) | 3.25 (–1.41 to 7.91) | 1.35 (–3.48 to 6.18) | 0.68 (–4.37 to 5.73) | |||
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g | 0.01 | 0.17 | –0.07 | –0.12 | |||
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.97 | .38 | .72 | .49 | ||||
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β (95% CI) | –0.07 (–4.22 to 4.08) | –2.04 (–6.59 to 2.51) | 0.76 (–3.41 to 4.92) | 1.36 (–2.51 to 5.24) | |||
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g | 0.23 | 0.23 | 0.25 | 0.09 | |||
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.20 | .23 | .23 | .62 | ||||
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β (95% CI) | –2.72 (–6.87 to 1.43) | –2.77 (–7.32 to 1.78) | –2.53 (–6.69 to 1.64) | –0.97 (–4.85 to 2.9) | |||
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g | 0.04 | 0.37 | 0.39 | –0.19 | |||
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.86 | . |
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.35 | ||||
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β (95% CI) | 0.36 (–3.77 to 4.5) | 4.58 (0.05 to 9.11) | 4.73 (0.58 to 8.87) | –1.85 (–5.7 to 2.01) | |||
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g | –0.25 | –0.42 | –0.73 | –0.05 | |||
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.15 |
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. |
.80 | ||||
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β (95% CI) | 3.01 (–1.12 to 7.14) | 5.32 (0.79 to 9.85) | 8.01 (3.87 to 12.16) | 0.49 (–3.37 to 4.35) | |||
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g | –0.03 | –0.21 | –0.50 | 0.05 | |||
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.89 | .27 |
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.80 | ||||
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β (95% CI) | 0.29 (–3.8 to 4.39) | 2.54 (–1.94 to 7.03) | 5.49 (1.38 to 9.6) | –0.48 (–4.3 to 3.34) | |||
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g | –0.22 | –0.06 | –0.29 | –0.21 | |||
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.21 | .75 | .13 | .24 | ||||
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β (95% CI) | 2.65 (–1.54 to 6.83) | 0.73 (–3.86 to 5.32) | 3.28 (–0.92 to 7.49) | 2.34 (–1.57 to 6.25) | |||
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g | 0.08 | 0.20 | 0.09 | 0.23 | |||
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.69 | .31 | .66 | .22 | ||||
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β (95% CI) | –0.74 (–4.37 to 2.9) | –2.4 (–7.02 to 2.22) | –1.08 (–5.86 to 3.71) | –3.15 (–8.15 to 1.86) | |||
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g | 0.01 | 0.47 | 0.20 | 0.28 | |||
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>.99 | . |
.32 | .13 | ||||
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β (95% CI) | 0.01 (–3.63 to 3.64) | –5.65 (–10.27 to –1.03) | –2.43 (–7.21 to 2.36) | –3.82 (–8.83 to 1.18) |
aSF-12: 12-item Short-Form Health Survey.
biTAU: improved treatment as usual.
cHLP: healthy lifestyle program.
dg: Hedge’s effect size measure
eStatistically significant values (
fβ: regression coefficient.
gMP: mindfulness program.
hPAPP: positive affect promotion program.
Visual analog scale of the EuroQol and Pemberton Happiness Index outcome analysis with imputed data (N=221): intervention comparisons along the follow-up.
Secondary outcomes | Time 1 (pretreatment) | Time 3 (6 months) | Time 4 (12 months) | ||
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gd | 0.02 | –0.20 | –0.33 |
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.91 | .31 | .08 | |
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βe (95% CI) | 0.47 (–7.93 to 8.87) | –3.82 (–11.17 to 3.53) | –6.56 (–13.86 to 0.75) |
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g | 0.17 | 0.18 | 0.16 |
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.33 | .33 | .39 | |
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β (95% CI) | –4.16 (–12.56 to 4.24) | –3.63 (–10.98 to 3.72) | –3.17 (–10.47 to 4.14) |
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g | 0.18 | 0.10 | 0.09 |
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.36 | .60 | .63 | |
|
|
β (95% CI) | –3.9 (–12.22 to 4.43) | –1.95 (–9.23 to 5.33) | –1.76 (–9.00 to 5.48) |
|
|
||||
|
|
g | 0.19 | –0.01 | –0.17 |
|
|
.29 | .96 | .58 | |
|
|
β (95% CI) | –4.63 (–13.14 to 3.88) | 0.19 (–7.26 to 7.63) | –2.04 (–9.21 to 5.2) |
|
|
||||
|
|
g | 0.21 | –0.10 | –0.24 |
|
|
.31 | .62 | .20 | |
|
|
β (95% CI) | –4.37 (–12.8 to 4.07) | 1.86 (–5.52 to 9.24) | 4.79 (–2.55 to 12.13) |
|
|
||||
|
|
g | –0.01 | –0.08 | –0.07 |
|
|
.95 | .65 | .71 | |
|
|
β (95% CI) | 0.26 (–8.17 to 8.7) | 1.68 (–5.7 to 9.06) | 1.4 (–5.93 to 8.74) |
|
|||||
|
|
||||
|
|
g | –0.05 | 0.19 | –0.18 |
|
|
.81 | .30 | .33 | |
|
|
β (95% CI) | –0.09 (–0.79 to 0.61) | 0.40 (–0.35 to 1.16) | –0.32 (–0.98 to 0.33) |
|
|
||||
|
|
g | 0.08 | –0.49 | –0.06 |
|
|
.65 | . |
.75 | |
|
|
β (95% CI) | –0.16 (–0.86 to 0.54) | 0.98 (0.22 to 1.73) | 0.11 (–0.55 to 0.77) |
|
|
||||
|
|
g | 0.10 | –0.42 | 0.09 |
|
|
.59 | . |
.61 | |
|
|
β (95% CI) | –0.19 (–0.89 to 0.5) | 0.82 (0.07 to 1.57) | –0.17 (–0.82 to 0.48) |
|
|
||||
|
|
g | 0.04 | –0.27 | –0.25 |
|
|
.84 | .14 | .20 | |
|
|
β (95% CI) | –0.07 (–0.78 to 0.64) | 0.57 (–0.19 to 1.34) | 0.43 (–0.23 to 1.1) |
|
|
||||
|
|
g | 0.06 | –0.2 | –0.08 |
|
|
.77 | .28 | .65 | |
|
|
β (95% CI) | –0.11 (–0.81 to 0.6) | 0.42 (–0.34 to 1.17) | 0.15 (–0.51 to 0.81) |
|
|
||||
|
|
g | 0.02 | 0.08 | 0.16 |
|
|
.93 | .68 | .41 | |
|
|
β (95% CI) | –0.03 (–0.74 to 0.67) | –0.16 (–0.92 to 0.6) | –0.28 (–0.94 to 0.38) |
aVAS EuroQol: visual analog scale of the EuroQol.
biTAU: improved treatment as usual.
cHLP: healthy lifestyle program.
dg: Hedge’s effect size measure
eβ: regression coefficient.
fMP: mindfulness program.
gPAPP: positive affect promotion program.
hPHI: Pemberton Happiness Index.
iStatistically significant values (
Positive and Negative Affect Scales outcome analysis with imputed data (N=221): intervention comparisons along the follow-up.
Secondary outcomes | Time 1 (pretreatment) | Time 2 (posttreatment) | Time 3 (6 months) | Time 4 (12 months) | ||||||
|
||||||||||
|
|
|||||||||
|
|
gd | 0.07 | –0.01 | 0.25 | 0.34 | ||||
|
|
.72 | .94 | .17 | .07 | |||||
|
|
βe (95% CI) | 0.45 (–1.96 to 2.85) | –0.12 (–3.47 to 3.23) | 2.24 (–1.00 to 5.48) | 3.36 (–0.30 to 7.01) | ||||
|
|
|||||||||
|
|
g | 0.14 | 0.00 | –0.16 | –0.33 | ||||
|
|
.44 | >.99 | .41 | .09 | |||||
|
|
β (95% CI) | –0.94 (–3.35 to 1.46) | –0.01 (–3.36 to 3.34) | 1.35 (–1.88 to 4.59) | 3.19 (–0.46 to 6.85) | ||||
|
|
|||||||||
|
|
g | 0.21 | 0.31 | 0.05 | –0.15 | ||||
|
|
.25 | .10 | .81 | .41 | |||||
|
|
β (95% CI) | –1.41 (–3.79 to 0.97) | –2.78 (–6.09 to 0.54) | –0.40 (–3.61 to 2.81) | 1.51 (–2.11 to 5.13) | ||||
|
|
|||||||||
|
|
g | 0.22 | –0.01 | 0.10 | 0.02 | ||||
|
|
.26 | .95 | .59 | .93 | |||||
|
|
β (95% CI) | –1.39 (–3.83 to 1.05) | 0.11 (–3.28 to 3.5) | –0.89 (–4.17 to 2.39) | –0.17 (–3.87 to 3.54) | ||||
|
|
|||||||||
|
|
g | 0.29 | 0.31 | 0.3 | 0.19 | ||||
|
|
.13 | .12 | .11 | .32 | |||||
|
|
β (95% CI) | –1.86 (–4.27 to 0.56) | –2.66 (–6.02 to 0.71) | –2.64 (–5.89 to 0.61) | –1.85 (–5.52 to 1.82) | ||||
|
|
|||||||||
|
|
g | 0.08 | 0.33 | 0.21 | 0.17 | ||||
|
|
.70 | .11 | .29 | .37 | |||||
|
|
β (95% CI) | –0.47 (–2.88 to 1.95) | –2.77 (–6.13 to 0.59) | –1.75 (–5.00 to 1.5) | –1.68 (–5.35 to 1.99) | ||||
|
||||||||||
|
|
|||||||||
|
|
g | –0.12 | –0.32 | –0.16 | –0.36 | ||||
|
|
.52 | .09 | .39 | .07 | |||||
|
|
β (95% CI) | –1.02 (–4.18 to 2.14) | –2.81 (–6.04 to 0.42) | –1.37 (–4.51 to 1.78) | –3.15 (–6.51 to 0.21) | ||||
|
|
|||||||||
|
|
g | –0.06 | 0.31 | 0.16 | 0.24 | ||||
|
|
.73 | .10 | .40 | .18 | |||||
|
|
β (95% CI) | 0.55 (–2.61 to 3.71) | –2.73 (–5.96 to 0.5) | –1.35 (–4.49 to 1.80) | –2.32 (–5.67 to 1.04) | ||||
|
|
|||||||||
|
|
g | 0.25 | 0.31 | 0.33 | 0.41 | ||||
|
|
.19 | .11 | .11 |
|
|||||
|
|
β (95% CI) | –2.09 (–5.22 to 1.04) | –2.59 (–5.79 to 0.61) | –2.54 (–5.65 to 0.57) | –3.63 (–6.96 to –0.31) | ||||
|
|
|||||||||
|
|
g | –0.19 | –0.01 | 0.00 | –0.09 | ||||
|
|
.33 | .96 | .99 | .63 | |||||
|
|
β (95% CI) | 1.57 (–1.63 to 4.78) | 0.07 (–3.20 to 3.35) | 0.02 (–3.17 to 3.20) | 0.83 (–2.57 to 4.23) | ||||
|
|
|||||||||
|
|
g | 0.13 | –0.03 | 0.14 | 0.06 | ||||
|
|
.51 | .90 | .46 | .78 | |||||
|
|
β (95% CI) | –1.07 (–4.24 to 2.11) | 0.21 (–3.03 to 3.46) | –1.17 (–4.33 to 1.98) | –0.48 (–3.85 to 2.89) | ||||
|
|
|||||||||
|
|
g | 0.3 | –0.02 | 0.15 | 0.14 | ||||
|
|
.10 | .93 | .46 | .44 | |||||
|
|
β (95% CI) | –2.64 (–5.82 to 0.53) | 0.14 (–3.10 to 3.38) | –1.19 (–4.35 to 1.96) | –1.32 (–4.69 to 2.06) |
aPANAS: Positive and Negative Affect Schedule.
biTAU: improved treatment as usual.
cHLP: healthy lifestyle program.
dg: Hedge’s effect size measure
eβ: regression coefficient.
fMP: mindfulness program.
gPAPP: positive affect promotion program.
hStatistically significant values (
A total of 81.1% (133/164) participants attended the initial face-to-face session. In HLP, 44% (24/54) of participants completed all web-based modules, in MP, 52% (28/54), and in PAPP, 32% (18/56; χ22=4.4;
The main objective of our study was to examine the efficacy of 3 low-intensity, internet-based psychological interventions when compared with that of the control condition (iTAU) in primary care in Spain.
Our main finding was that there were differences in the short term in favor of internet-based psychological interventions, specifically HLP and MP. This finding is consistent with the literature that has shown that brief psychotherapy is efficacious for the treatment of depression in primary care [
Furthermore, we found differences between the 3 interventions groups and control group (iTAU) regarding health-related quality of life. In particular, we observed short- and medium-term differences in favor of HLP and MP in physical health status, and in medium term for PAPP. These results demonstrated that the 3 low-intensity, internet-based psychological interventions in primary care are also effective in improving medium- and long-term quality of life. This finding is highly important, for, as is well known, depression is associated with serious disability and loss in quality of life [
Differences were also found in well-being and affect between intervention and control groups. In particular, we observed differences in medium term regarding well-being in MP compared with that in iTAU. In PAPP, differences were found in medium and long term with regard to well-being and, in long term, with regard to negative affect in favor of psychotherapy. This finding shows us that although PAPP seems to be ineffective in reducing depressive symptomatology, it could be effective in improving health-related quality of life and well-being in patients with depression.
Regarding treatment adherence, our completion treatment rates were relatively low in each intervention group. Dropout treatment is common in internet intervention programs, although rates vary depending on the support provided along the intervention or the context [
A possible explanation could be that in our study, there was an initial face-to-face group session, in which the final goal was to reinforce commitment and adherence to treatment, as well as, to explain the program structure and main components of treatment, clarify the instructions for the use of the web-based platform, and motivate participants to change. Thus, perhaps these measures could have increased our completion rates.
This trial presents several limitations, which should be mentioned. First, not all participants completed posttest measurements, and a high attrition rate at follow-up was found. Although missing values were corrected by using multiple imputations, the results should be interpreted with caution. Second, just as difficulties in recruiting patients is an important issue in clinical trials [
Our study has a significant strength: to the best of our knowledge, this is the first trial in Spain aimed at improving the symptomatology and quality of life of patients with depression using low-intensity interventions applied by the information and communication technologies. The treatment programs used in this study include therapeutic strategies based on mindfulness, healthy lifestyle, and positive affect, which have proven their efficacy for the treatment of depression; nevertheless, it is still the first study that adapts these interventions to information and communication technologies.
This study has 3 important conclusions. First, 2 low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care were more effective than iTAU at posttreatment. Second, all low-intensity, internet-based psychological interventions were also effective in improving medium- and long-term quality of life. Finally, PAPP was effective for improving health-related quality of life and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated in the ineffectiveness of PAPP in reducing depressive symptomatology, such as the intervention length, population, and treatment adherence, to increase its effectiveness in future studies of internet-based interventions programs for depression. Overall, our results suggest that although low-intensity, internet-based psychological programs are an efficacious therapeutic option for the treatment of depression in primary care, subsequent and more complex analyses are necessary to explain the reasons why some interventions appeared to affect some outcomes but not others. Furthermore, more research is still needed to assess the cost-effectiveness analysis of these interventions.
Primary outcome analysis with imputed data adjusted to Sex and Age (N=221): intervention comparisons along the follow-up.
Dose-response in imputed and adjusted (Sex and Age) primary outcome at post-treatment and along the follow-up.
SF-12 (Mental and Physical) analysis with imputed data adjusted to Sex and Age (N=221): intervention comparisons along the follow-up.
EuroQoL (VAS) and PHI analysis with imputed data adjusted to Sex and Age (N=221): intervention comparisons along the follow-up.
PANAS (positive and negative affect scales) analysis with imputed data adjusted to Sex and Age (N=221): intervention comparisons along the follow-up.
CONSORT-eHEALTH checklist (V 1.6.1).
Complier Average Causal Effect
cognitive behavioral therapy
healthy lifestyle program
improved treatment as usual
Multiple Imputation with Chained Equation
mindfulness program
national minimum wage
Positive and Negative Affect Schedule
positive affect promotion program
Pemberton Happiness Index
Patient Health Questionnaire-9
Short-Form Health Survey
visual analog scale
This study was financed by the Instituto de Salud Carlos III of the Spanish Ministry of Economy and Competitiveness with the PI13/01171 grant (Efficacy and cost-effectiveness of the low-intensity psychological interventions applied by ICTs for the treatment of depression in primary care: a controlled trial). The authors would like to thank the Institut d’Investigació Sanitaria de les Illes Balears (IdiSBa) for the assistance received on statistical analysis queries.
None declared.