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Internet-based cognitive behavioral therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (FtF) consultations in a blended format may produce a new treatment format (B-CBT) with multiple benefits from both traditional CBT and iCBT, such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation.
The primary aim of this study is to compare directly the clinical effectiveness of B-CBT with FtF-CBT for adult major depressive disorder.
A 2-arm randomized controlled noninferiority trial compared B-CBT for adult depression with treatment as usual (TAU). The trial was researcher blinded (unblinded for participants and clinicians). B-CBT comprised 6 sessions of FtF-CBT alternated with 6-8 web-based CBT self-help modules. TAU comprised 12 sessions of FtF-CBT. All participants were aged 18 or older and met the diagnostic criteria for major depressive disorder and were recruited via a national iCBT clinic. The primary outcome was change in depression severity on the 9-item Patient Health Questionnaire (PHQ-9). Secondary analyses included client satisfaction (8-item Client Satisfaction Questionnaire [CSQ-8]), patient expectancy (Credibility and Expectancy Questionnaire [CEQ]), and working (Working Alliance Inventory [WAI] and Technical Alliance Inventory [TAI]). The primary outcome was analyzed by a mixed effects model including all available data from baseline, weekly measures, 3-, 6, and 12-month follow-up.
A total of 76 individuals were randomized, with 38 allocated to each treatment group. Age ranged from 18 to 71 years (SD 13.96) with 56 (74%) females. Attrition rate was 20% (n=15), which was less in the FtF-CBT group (n=6, 16%) than in the B-CBT group (n=9, 24%). As many as 53 (70%) completed 9 or more sessions almost equally distributed between the groups (nFtF-CBT=27, 71%; nB-CBT=26, 68%). PHQ-9 reduced 11.38 points in the FtF-CBT group and 8.10 in the B-CBT group. At 6 months, the mean difference was a mere 0.17 points. The primary analyses confirmed large and significant within-group reductions in both groups (FtF-CBT: β=–.03; standard error [SE] 0.00;
With large within-group effects in both treatment arms, the study demonstrated feasibility of B-CBT in Denmark. At 6 months’ follow-up, there appeared to be no difference between the 2 treatment formats, with a small but nonsignificant difference at 12 months. The study seems to demonstrate that B-CBT is capable of producing treatment effects that are close to FtF-CBT and that completion rates and satisfaction rates were comparable between groups. However, the study was limited by small sample size and should be interpreted with caution.
ClinicalTrials.gov NCT02796573; https://clinicaltrials.gov/ct2/show/NCT02796573
RR2-10.1186/s12888-016-1140-y
Depression is a prevalent and disabling disorder with a high risk of relapse and large individual and societal costs [
Combining iCBT with traditional face-to-face (FtF) consultations in a blended CBT format (B-CBT), in which both online components and FtF sessions are included in 1 coherent CBT protocol, may alleviate some of the difficulties associated with iCBT for depression, while preserving some of the advantages of both iCBT and FtF-CBT alike. First, by including FtF sessions, the therapist can individualize the therapy taking the idiosyncratic case formulation of the patient, the specific disorder, and possible comorbidity into account. Second, as B-CBT in the format tested in this study only provides half the number of sessions as traditional FtF-CBT, the capacity of the treating clinician is increased compared with traditional CBT. Third, the burden and cost of travel by the patient can be reduced compared with FtF-CBT. Fourth, the online modules are available at the time and place needed by the patients—and they can be re-viewed multiple times. Fifth, the inherently structured format of the online modules ensures high treatment fidelity, for example, by delivering the same psychoeducation and exercises to all patients. Sixth, one of the principal barriers for the uptake of iCBT seems to be skepticism concerning allotting the majority of therapy to a computer [
Few studies have investigated the use of blended care combining internet-based psychotherapeutic modules and FtF sessions into 1 coherent treatment manual to treat adult depression [
In this study we compared directly the clinical effect on adult depression of B-CBT and FtF-CBT in a randomized, controlled, noninferiority study in parallel groups, recruiting from a routine care iCBT clinic in the Region of Southern Denmark.
The primary aim of this study was to compare the clinical effectiveness of B-CBT for major depressive disorder in adults with treatment as usual (TAU) defined as 12 sessions of FtF-CBT. It is hypothesized that B-CBT will be no less clinically effective than FtF-CBT, and that it will be acceptable and satisfactory to patients and clinicians.
The study was a randomized, controlled, noninferiority trial comparing B-CBT with FtF-CBT. It was part of the research program e-Mental Health Research (ENTER) located in and coordinated from the Centre for Telepsychiatry in the Mental Health Services of Southern Denmark, Odense. Additionally, this study was affiliated with the European Union (EU) study E-COMPARED [
The trial was approved by the Ethics Committee of the Region of Southern Denmark (registration number S-20150150) prior to instigation. The trial followed the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects [
The trial was registered with ClinicalTrials.gov NCT02796573. The trial protocol was published previously [
Funding was granted from the Research Fund of the Mental Health Services of Southern Denmark, and from the Innovation Fund Denmark, as part of the project ENTER (ID: 5159-00002B). Both are public funds. None of the funds have had any role in the design of the study nor in the collection, analysis or interpretation of the data, or writing of the manuscript.
All participants were 18 years of age or older and met the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition text revision (DSM-IV-TR) [
Participants were recruited from March 1, 2016, to April 1, 2018, from the iCBT clinic “Internetpsykiatrien,” which is situated within secondary mental health care (Centre for Telepsychiatry) at the Mental Health Services of the Region of Southern Denmark [
An independent researcher from the EU study E-COMPARED [
It was not possible to blind the patients nor the treating clinicians to the allocated treatment. However, those assessing the participants were blinded to allocation as were the researchers and statisticians involved up until the point of interpretation of the results. Some questionnaires were only administered to the B-CBT group and were kept in a separate data set.
In the blended condition, 6 individual FtF-CBT sessions were alternated with 6-8 online CBT modules delivered through an internet-based treatment program. The FtF consultations were provided by a psychologist at the Centre for Telepsychiatry with physical presence by the participants and the therapists.
The program (NoDep) was previously developed (2015) as part of a public private innovation project between The Region of Southern Denmark and Context Consulting. It was based on CBT for depression and included 6 mandatory modules and 2 optional ones. The core components of the mandatory modules were psychoeducation, cognitive restructuring, behavioral activation, behavior experiments, and relapse prevention. The optional modules comprised coping with rumination and restructuring of core beliefs. All online modules were introduced in the FtF sessions. Modules the participants had previously worked with could be addressed in the FtF sessions if needed. The decision as to whether any optional modules need to be added was taken jointly by the patient and the psychologist based on patient needs, motivation, and possible time constraints. See
Overview of interventions.
Intervention and session number | Format of delivery | Content | Example of exercise | |
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1 | FtFb | Introduction and psychoeducation about depression and the treatment | Find a helper |
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2 | Online module | Introduction to the program, psychoeducation about depression, and goals for the treatment | Problem/goal list |
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3 | FtF | Idiosyncratic model of the disorder | Cognitive case formulation |
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4 | Online module | Psychoeducation about behavior in depression | Activity registration |
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5 | FtF | Accordance between personal values and behavior. Introduction to cognitive restructuring | Simple exercise for cognitive restructuring |
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6 | Online module | Changing behavior based on activity registration and personal values | Activity planning |
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7 | FtF | Psychoeducation about negative automatic thoughts and cognitive restructuring | Cognitive restructuring exercise |
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8 | Online module | Psychoeducation about negative automatic thoughts and cognitive restructuring | Cognitive restructuring exercise |
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9 | FtF | Psychoeducation about behavioral experiments. Decision is made as to whether to include either or both of the extra modules | Behavioral experiment |
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10 | Online module (A, B) | Behavioral experiments (A: psychoeducation about core beliefs, B: coping with rumination) | Behavioral experiment (A: challenge core beliefs; B: test 3 techniques for coping with rumination) |
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11 | FtF | Summing up, relapse prevention | Continuation of preferred exercises |
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12 | Online module | Summing up, relapse prevention | Personal relapse prevention plan |
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1 | FtF | Introduction and psychoeducation about depression and the treatment | Find a helper |
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2 | FtF | Psychoeducation and goals for the treatment | Problem/goal list |
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3 | FtF | Idiosyncratic model of the disorder | Cognitive case formulation |
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4 | FtF | Psychoeducation about behavior in depression | Activity registration |
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5 | FtF | Accordance between personal values and behavior. Introduction to cognitive restructuring | Simple exercise for cognitive restructuring |
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6 | FtF | Changing behavior based on activity registration and personal values | Activity planning |
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7 | FtF | Psychoeducation about negative automatic thoughts and cognitive restructuring | Cognitive restructuring exercise |
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8 | FtF | Psychoeducation about negative automatic thoughts and cognitive restructuring | Cognitive restructuring exercise |
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9 | FtF | Psychoeducation about behavioral experiments | Behavioral experiment |
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10 | FtF | Psychoeducation about core beliefs or continue working on behavioral experiments | Challenge core beliefs or behavioral experiment |
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11 | FtF | Psychoeducation about rumination or beginning of relapse prevention | Test 3 techniques to cope with rumination or start personal relapse prevention plan and continuation of preferred exercise |
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12 | FtF | Summing up, relapse prevention | Personal relapse prevention plan |
aB-CBT: blended cognitive behavioral therapy.
bFtF: face-to-face.
cTAU: treatment as usual.
To provide technical support to the participants, the existing procedures at the Centre for Telepsychiatry were used, which consisted of 2 levels: the first was handled by the clinicians, the second went through an error report system to the company that provided the software (Context Consulting).
No important changes were made to the program or the protocol during the trial.
TAU defined as 12 sessions of FtF-CBT was also provided by a psychologist at the Centre for Telepsychiatry with physical presence and comprised the same core components as the B-CBT condition. Additionally, interventions on core beliefs and rumination could be included according to the same criteria as in the B-CBT condition. See
Both treatment conditions were described in a single common treatment protocol, thus ensuring similar treatment content and order of interventions across the 2 groups. They were both intended to last approximately 12 weeks.
Patients in either condition were monitored weekly for symptoms of depression including suicidal ideation and intent. In case a participant’s condition deteriorated or showed signs of suicidal intent, a standard assessment procedure used in all of the secondary mental health care services in the Region of Southern Denmark was conducted. The patient was discontinued if necessary and referred to other relevant treatment.
Licensed clinical psychologists or psychologists under supervision of the primary researcher (KM), who is also a licensed clinical psychologist, delivered all FtF consultations. To assess clinician fidelity [
To increase adherence, participants received automated reminders of homework assignments and questionnaires. Furthermore, in case a participant was inactive, he or she would be contacted by telephone or email. Additionally, in case a participant was unwilling or unable to engage with the program at home, a computer was set up at the clinic, for participants to engage with the online program on-site. This was never used, however.
After consent was granted, baseline measures were administered prior to randomization. Follow-up measurements were conducted 3, 6, and 12 months after baseline. Additionally, weekly measures were provided during treatment. The questionnaire packages were administered online using a secure web application for building and managing online surveys (REDCap), except for the weekly monitoring of the B-CBT group, for which the packages were administered automatically by the treatment program.
Data were stored by the Odense Patient data Exploratory Network (OPEN) [
The PHQ-9 [
A number of additional measures were administered to assess different aspects of the participants’ symptomatology and experience during the treatments. The 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) [
Characteristics of the sample at baseline was described using descriptive statistics and compared across groups using unpaired
For the primary analyses a linear multilevel mixed effects model with restricted maximum likelihood estimator was used as intention-to-treat analyses. PHQ-9 scores were used as response variable. Time was included as a fixed effect and as a random effect nested within participant (random slope and intercept) [
All inferences assumed normally distributed error terms and heteroscedasticity, which were substantiated by visual inspection of a q-q normality plot and a plot of fitted values versus standardized residuals.
Remission was defined as a score of <5 on the PHQ-9. Response to treatment was defined as 50% or more reduction on the PHQ-9.
The noninferiority margin was set to
Acceptability was estimated from measures of client satisfaction (CSQ-8) and working alliance as reported by the participants (WAI-SR and Technical Alliance Inventory [TAI]) and the clinicians (WAIc). Means were compared across groups using unpaired
Mixed effects models using all available data were applied for analyses of interactions between group and baseline variables by the intention-to-treat principle. One model per predictor was used with PHQ-9 as the response variable in a series of univariate analyses. This was done to test whether baseline characteristics affected outcome differently in the 2 treatments. Inclusion of all parameters would have overfitted the model due to sample size. Time was included as both a fixed effect and a random effect nested in individuals (similar to the primary analysis).
Second, analyses of predictors of symptomatic change in the total sample were also conducted using a mixed effects model with PHQ-9 as response variable. Both multivariate and a series of univariate analyses were conducted. No group interaction was included in these analyses.
Having completed 9 or more (75%) sessions (out of 12) was counted as completion and mean completion rates were compared between groups by unpaired
To assess the odds of noncompletion predicted from the participants’ baseline characteristics, a multivariate logistic regression analysis was conducted. As the response variable, a dichotomous variable for completion was used. Additionally, univariate logistic regression analyses were conducted using 1 model per predictor to investigate whether noncompletion was predicted differently between the FtF-CBT treatment and the B-CBT, which included an interaction term with group.
All calculations were performed using R version 3.4.4 (R Foundation for Statistical Computing) [
The included sample was predominantly female (56/76, 74%) and young with a mean age of 35.0 (SD 13.96) years (median 30 years), although a large age range was seen (18-71 years). Most had moderate to highly severe levels of depression (66/76, 87%) with a mean score of 15.25 (SD 4.04) on the PHQ-9.
No significant differences were observed between the 2 groups on baseline characteristics except for scores on the CEQ measuring the participants’ expectations and credibility of the treatments (see
Among the included sample, 7 were on the brink of violating exclusion criteria, 3 were in psychological treatment at the point of assessment, 2 had some obsessive compulsive disorder symptoms, and 2 were not depressed according to MINI, but scored 9 and 17 on the PHQ-9, respectively. When comparing analyses including or excluding these cases, the outcome did not change. To avoid causing any changes to the analysis plan, all analyses were performed including these participants.
Characteristics of participants (N=76)a.
Characteristics | FtF-CBTb | B-CBTc | ||
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Age, mean (SD) | 35.16 (14.14) | 34.78 (13.98) | .91 |
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Female gender, n/N (%) | 29/37 (78) | 27/37 (73) | .79 |
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PHQ-9d, mean (SD) | 16.05 (3.83) | 14.42 (4.14) | .08 |
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Credibility, mean (SD) | 0.67 (2.01) | –0.69 (2.28) | .009e |
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Expectancy, mean (SD) | 0.70 (2.22) | –0.72 (2.88) | .02f |
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Single | 13/37 (35) | 14/37 (38) |
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Divorced | 5/37 (14) | 6/37 (16) |
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Widow/widower | 0/37 (0) | 0/37 (0) |
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Cohabiting | 9/37 (24) | 8/37 (22) |
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Married | 10/37 (27) | 8/37 (22) |
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Prefer not to answer | 0/37 (0.0) | 1/37 (3) |
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Further education <3 years | 7/37 (19) | 8/37 (22) |
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Further education 3-4 years | 13/37 (35) | 13/37 (35) |
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Higher education >4 years | 4/37 (11) | 3/37 (8) |
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Fundamental school <8 years | 0/37 (0) | 0/37 (0) |
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Fundamental school 9-10 years | 3/37 (8) | 3/37 (8) |
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Gymnasium (3 years) | 9/37 (24) | 5/37 (14) |
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Skilled worker | 1/37 (3) | 5/37 (14) |
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.34 | |
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Full-time employed | 9/36 (25) | 4/34 (12) |
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Part-time employed | 5/36 (14) | 9/34 (27) |
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Sick leave | 11/36 (31) | 9/34 (27) |
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Leave of absence | 2/36 (6) | 0/34 (0) |
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Retired | 1/36 (3) | 1/34 (3) |
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Unemployed | 8/36 (22) | 11/34 (32) |
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.82 | |
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No preference | 16/37 (43) | 18/36 (50) |
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Blended care | 9/37 (24) | 7/36 (19) |
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Face-to-face | 12/37 (32) | 11/36 (31) |
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No | 0/37 (0) | 0/36 (0) |
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Mild | 3/37 (8) | 4/36 (11) |
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Moderate | 9/37 (24) | 14/36 (39) |
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Severe | 19/37 (51) | 16/36 (44) |
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Highly severe | 6/37 (16) | 2/36 (6) |
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aPercentages calculated considering attrition.
bFtF-CBT: face-to-face cognitive behavioral therapy.
cB-CBT: blended cognitive behavioral therapy.
dPHQ-9: 9-item Patient Health Questionnaire.
e
f
Patient flow. *We did not store any data on any patients who had not provided informed consent. Consequently, no reasons can be provided for this category. **Treatment was regarded as completed when more than 9 sessions were completed. B-CBT: blended cognitive behavioral therapy; FtF-CBT: face-to-face cognitive behavioral therapy.
Initially, we report observed means (
Change in depression on PHQ-9. B-CBT: blended cognitive behavioral therapy; FtF-CBT: face-to-face cognitive behavioral therapy; PHQ-9: 9-item Patient Health Questionnaire.
In both groups, large changes in the mean scores within groups were observed on the primary outcome measure (PHQ-9;
Between groups, a trend in effect size was noted favoring the FtF-CBT group at 3 months’ follow-up (
Observed means for PHQ-9a.
Timepoint | FtF-CBTb | B-CBTc | |||
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Mean (SEd) | Mean (SE) | |||
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Mean | 16.05 (0.63) |
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14.42 (0.69) |
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Mean | 7.71 (0.7) |
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9.93 (0.92) |
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Between-groups effect sizee |
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–0.5 (–1.62 to –1.17) |
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Within-group effect sizef |
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–2.04 (–2.91 to –1.17) |
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–1.57 (–2.68 to –0.46) |
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Mean | 6.97 (1.09) |
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6.8 (0.99) |
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Between-groups effect sizee |
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0.03 (–1.43 to 1.49) |
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Within-group effect sizef |
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–2.09 (–3.29 to –0.89) |
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–1.52 (–2.67 to –0.37) |
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Mean | 4.67 (0.62) |
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6.32 (0.95) |
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Between-groups effect sizee |
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–0.42 (–1.49 to 0.65) |
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Within-group effect sizef |
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–2.04 (-2.91 to –1.17) |
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–1.57 (–2.68 to –0.46) |
aPHQ-9: 9-item Patient Health Questionnaire.
bFtF-CBT: face-to-face cognitive behavioral therapy.
cB-CBT: blended cognitive behavioral therapy.
dSE: standard error.
eIndependent samples [
fFormula 3 in Dunlap et al [
Change in depression on QIDS. B-CBT: blended cognitive behavioral therapy; QIDS: Quick Inventory of Depressive Symptomatology; TAU: treatment as usual.
As can be seen in
A negative correlation was observed between intercept and slope in the primary model (
Results of the mixed effects linear regressions.
Fixed effects | Primary analysis | Within-group FtF-CBTa | Within-group B-CBTb | |||||||
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Estimates | SEc | Estimates | SE | Estimates | SE |
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(Intercept) | 12.71 | 0.61 | <2 × 10–16d | 12.71 | 0.60 | 2 × 10–16d | 12.47 | 0.64 | <2 × 10–16d |
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Time | –0.03 | 0.00 | 3.12 × 10–16d | –0.03 | 0.00 | 2.24 × 10–11d | –0.02 | 0.00 | 3.59 × 10–9d |
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Group B-CBT | –0.23 | 0.89 | .80 | N/Ae | N/A | N/A | N/A | N/A | N/A |
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Time × group B-CBT | 0.01 | 0.00 | .03f | N/A | N/A | N/A | N/A | N/A | N/A |
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aFtF-CBT: face-to-face cognitive behavioral therapy.
bB-CBT: blended cognitive behavioral therapy.
cSE: standard error.
d
eN/A: not applicable.
f
There was no significant difference in client satisfaction between groups (mean difference –2.18; t39.36=2.16;
The rates of participants responding to treatment at 12 months based on the PHQ-9 were 83% (25/30) in the FtF-CBT group and 64% (14/22) in the B-CBT group. The remission rates at 12 months were 60% (18/30) for the FtF-CBT group and 50% (11/22) for the B-CBT group. When inspecting all individual slopes of the primary model, we found no negative individual slopes, indicating that none of the participants’ depressive condition deteriorated.
Finally, 20 randomly selected audio-recorded sessions were examined for treatment fidelity by an external expert in clinical psychology. Among the sample, session numbers ranged from 3 to 12, 3 of 4 therapists were represented, and both groups were well represented, with 14 sessions being from the FtF-CBT group. The mean score of treatment fidelity was 4.25 (SD 0.71) on a scale ranging from 1 (not compliant with the protocol) to 5 (completely compliant with the protocol).
In a multivariate analysis of the total sample, only being on sick leave and preferring blended care predicted outcome. Being on sick leave added to the slope (3.96; SE 1.54;
In a series of univariate interaction analyses of each parameter × group, there was a significant interaction effect of being part-time employed (β=–5.83; SE 2.68;
Predictor analysis.
Variables | Estimate | SEa | ||
(Intercept) | 16.85 | 4.11 | <.001 | |
Time | –0.02 | 0.00 | <.001 | |
Age | 0.00 | 0.07 | .98 | |
Female sex | –0.51 | 0.07 | .71 | |
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Divorced | –0.98 | 2.07 | .64 |
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Cohabiting | 0.23 | 1.39 | .87 |
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Married | –4.08 | 2.06 | .06 |
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No answer | –1.41 | 3.98 | .73 |
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Further education 3-4 years | –1.76 | 1.45 | .23 |
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Higher education > 4 years | –3.08 | 1.76 | .09 |
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Fundamental school 9-10 years | –2.85 | 3.14 | .37 |
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High school (3 years) | –3.41 | 1.76 | .06 |
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Skilled worker | –0.80 | 2.55 | .76 |
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Part-time employed | 1.09 | 1.70 | .53 |
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Sick leave | 3.96 | 1.54 | .02b |
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Leave of absence | 1.48 | 3.12 | .64 |
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Retired | –0.53 | 3.48 | .88 |
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Unemployed | 0.26 | 1.63 | .87 |
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Blended care | –3.25 | 1.53 | .04b |
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Face-to-face | –1.18 | 1.28 | .36 |
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Credibility | 0.24 | 0.31 | .45 |
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Expectancy | –0.37 | 0.28 | .20 |
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System usability | –0.05 | 0.11 | .73 |
aSE: standard error.
b
In total, 53 (70%) completed the treatment; 27 (71%) from the FtF-CBT group and 26 (68%) from the B-CBT group. Completers as well as noncompleters showed a significant effect of time (completers: β=–.03,
In the FtF-CBT group, a mean of 9.8 sessions was completed. In the B-CBT group, a mean of 9.2 sessions was completed. The mean difference was not significant (t74=–0.70,
We did not find any variables that significantly predicted noncompletion in multivariate analyses of the total sample nor did we find any interaction effect between any of the baseline characteristics and groups in a series of univariate analyses, indicating no difference in risk of noncompletion on any baseline characteristic between groups.
Reasons for noncompletion (n=15).
Reasons for noncompletion | Value, |
Inactive | 2 |
No reason given | 7 |
Felt it was too strenuous | 1 |
Referred to other treatment | 2 |
Wished to end the treatment | 2 |
Felt unable to profit from the treatment | 1 |
The main aim of this study was to compare the clinical effectiveness of B-CBT with traditional FtF-CBT, because the blended format may hold the promise to combine advantages of the traditional and the new format of delivery. In this study, we found very similar trajectories of improvement in both groups as well as on measures of other parameters, such as working alliance and retention. However, it was possible to detect a significant difference between groups in slight favor of FtF-CBT.
The sample corresponded well with what is seen among patients with depression in the primary health care sector in Denmark regarding gender and age distribution [
The mean symptomatic change observed in the B-CBT condition closely approximated that of the FtF-CBT group. This is in line with meta-analyses of guided iCBT for depression [
The working alliance between the patient and clinician has often been argued to be one of the most important nonspecific factors of psychotherapy [
Acceptability of the blended format seemed to be high as judged by levels of client satisfaction and working alliance, where no significant differences were observed. Furthermore, high retention rates among participants and high treatment fidelity rates for the clinicians indicated satisfaction and acceptability with the treatment.
As is commonly found [
Interestingly, 1 variable was able to distinguish between the 2 groups in predicting outcome differently. An interaction effect was observed between employment status and group. Being part-time employed or unemployed both favored the blended care group. We speculate that this may be due to the B-CBT treatment always being available, possibly increasing the chance of treatment engagement if the participant has more free time. Consequently, this is a potential candidate variable for stratification of treatment or a prescriptive variable. In a different approach comparing variables predicting outcomes separately for the 2 groups in a larger sample across 4 countries [
This study is well aligned with previous observations of completion rates in both guided iCBT and traditional CBT [
In disagreement with what has previously been found in guided iCBT, we observed that no baseline characteristics predicted noncompletion [
This study compared directly the formats of delivery with a minimum of the variance explained by differences in therapeutic methods, which is both a strength and a weakness of the design. While it lends itself well to compare the 2 treatment formats, it also somewhat limits the ecological validity, making it more difficult to make inferences about the clinical effect in routine care. Furthermore, because the study recruited from Internetpsykiatrien, which offers self-referral, even though the clinic is situated in secondary care, it can be difficult to generalize to future implementations. Additionally, only the B-CBT group received reminders about homework assignments. This might be a confounder, for example, there is a risk participants in this group grew weary of the reminders, thus affecting the perception of the treatment negatively. Finally, due to the small sample size, we had difficulty inferring noninferiority, although the many observations and advanced statistical procedures appear to have compensated for that to some degree. The large EU study E-COMPARED will be able to pool data from many studies, including this one, and may thus be able to reach more robust conclusions about noninferiority.
In this study, feasibility of B-CBT was demonstrated as well as large and significant within-group effect sizes were produced. In fact, it was seen that practically without loss of treatment effect, completion rates, and therapeutic alliance, it was possible to substitute half of the FtF consultations with online modules when treating adult depression. This is remarkable and lends support to the hypothesis of noninferiority of B-CBT and should lead to the further study of this promising treatment format. However, it should also be noted that small differences were observed favoring the FtF-CBT group. Although not significant, it may be that FtF treatment works faster, and has a better long-term effect for some patients. The results, therefore, need to be replicated in larger samples or with pooled data from multicenter trials as will be done in the E-COMPARED study. Additionally, further studies should explore the applicability of B-CBT in different patient populations and clinical settings. Furthermore, participants’ digital health literacy should be measured in future studies.
CONSORT-eHEALTH checklist (V 1.6.1).
blended cognitive behavioral therapy
Beck Depression Inventory II
cognitive behavioral therapy
Credibility and Expectancy Questionnaire
8-item Client Satisfaction Questionnaire
Diagnostic and Statistical Manual of Mental disorders 4th edition text revision
e-Mental Health Research
European Union
face-to-face cognitive behavioral therapy
Mini-International Neuropsychiatric Interview
Odense Patient data Exploratory Network
9-item Patient Health Questionnaire
16-item Quick Inventory of Depressive Symptomatology Self-Report
standard error
Technical Alliance Inventory
treatment as usual
Working Alliance Inventory-Short Revised
World Health Organization
Funding was granted from the Research Fund of the Mental Health Services of Southern Denmark and from the Innovation Fund Denmark as part of the project ENTER (ID: 5159-00002B). Both are public funds. None of the funds have had any role in the design of the study nor in collection of data, analysis of data, interpretation of data, or writing of the manuscript. The authors acknowledge the E-COMPARED project. We also acknowledge Odense Patient Data Exploratory Network and the Mental Health Services of Southern Denmark and Centre for Telepsychiatry.
KM is the main author of this work and has taken part in designing and planning the study, performing analyses and writing up the article. TEA is the cosupervisor of this study and contributed to study design and statistical analysis plan. AK is the author of the E-COMPARED generic protocol, which formed the foundation for this protocol. HR is the comain supervisor, coauthor of the E-COMPARED generic protocol, and contributed to the design of this study. KKR is the main supervisor, contributed to the study design, and assisted in the process of authoring this article in its entirety. MBL and LHE have contributed to planning the study and MBL has also participated in data collection. All contributors have, in addition to the above, proofread the article.
The software NoDep was developed jointly by the Region of Southern Denmark and the private partner Context Consulting. KM participated in the development process as representative of the public partner Region of Southern Denmark. KM has no affiliations to any of the private vendors involved in the project including Context Consulting and gains no economic income from sales of licenses. The other authors declare that they have no competing interests.