The Clinical Effectiveness of Blended Cognitive Behavioral Therapy Compared With Face-to-Face Cognitive Behavioral Therapy for Adult Depression: Randomized Controlled Noninferiority Trial

Abstract

Background 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. Objective The primary aim of this study is to compare directly the clinical effectiveness of B-CBT with FtF-CBT for adult major depressive disorder. Methods 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. Results 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; P<.001 and B-CBT: β=–.02; SE 0.00; P<.001). A small but significant interaction effect was observed between groups (β=.01; SE 0.00; P=.03). Employment status influenced the outcome differently between groups, where the B-CBT group was seen to profit more from not being full-time employed than the FtF group. Conclusions 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. Trial Registration ClinicalTrials.gov NCT02796573; https://clinicaltrials.gov/ct2/show/NCT02796573 International Registered Report Identifier (IRRID) RR2-10.1186/s12888-016-1140-y

Effectiveness of Blended Cognitive Behavioral Therapy Versus Treatment as Usual for Depression in Routine Specialized Mental Healthcare: E-COMPARED Trial in the Netherlands

“…Our findings are in line with previous studies on blended treatment for depression and anxiety, suggesting comparable clinical effects between the blended and control intervention (Kooistra et al, 2019;Ly et al, 2015;Mathiasen et al, 2022;Nakao et al, 2018;Romijn et al, 2021b;Thase et al, 2018). Results from Berger et al (2018) and Zwerenz et al (2017) indicated moderate between-group effect sizes in favor of blended, but these studies offered the online component as an adjunctive tool to usual care rather than an integrated blended treatment protocol as replacement of usual psychotherapeutic care.…”

“…Results from Berger et al (2018) and Zwerenz et al (2017) indicated moderate between-group effect sizes in favor of blended, but these studies offered the online component as an adjunctive tool to usual care rather than an integrated blended treatment protocol as replacement of usual psychotherapeutic care. Furthermore, trials are not fully comparable regarding the treatments that were received in the comparison groups, consisting of either standard CBT (Kooistra et al, 2019;Ly et al, 2015;Mathiasen et al, 2022;Thase et al, 2018), usual treatment with a psychotherapist (Berger et al, 2018) or psychiatrists (Nakao et al, 2018), or TAU with access to an online platform (Zwerenz et al, 2017). This makes direct comparisons of between-group effect sizes difficult.…”

Analyzing the Effect of Telemedicine on Domains of Quality Through Facilitators and Barriers to Adoption: Systematic Review

“…This theme included maximum oxygen consumption, comparison of bad cholesterol with good cholesterol, pain, diastolic blood pressure, systolic blood pressure, hypoglycemia, lipids, overall blood pressure, average blood sugar over last 3 months, physical function, fasting blood glucose, cholesterol, and BMI. There were 17% (16/92) of instances of increased mental health [ 31 , 32 , 37 , 39 , 43 , 45 , 47 , 54 , 57 ]. This theme encompassed anxiety, well-being, stress, loneliness, depression, fear, personal satisfaction, helplessness, rumination, acceptance, suicidal ideation, and resilience.…”

“…This theme encompassed anxiety, well-being, stress, loneliness, depression, fear, personal satisfaction, helplessness, rumination, acceptance, suicidal ideation, and resilience. There were 13% (12/92) of instances of improved medical engagement [ 28 , 30 , 32 , 35 , 36 , 40 , 43 , 46 , 48 , 60 ]. This theme included medication compliance, program or treatment adherence, follow-up visits, medical knowledge, and decrease in emergency department visits.…”

“…All these 33 studies reported the positive effectiveness of telemedicine as a modality across all 6 domains of quality. These studies showed positive outcomes in physical [ 30 , 33 , 39 - 42 , 44 , 47 , 49 , 51 - 55 , 57 , 58 ] and mental health [ 31 , 32 , 37 , 39 , 43 , 45 , 47 , 54 , 57 ], medical engagement [ 28 , 30 , 32 , 35 , 36 , 40 , 43 , 46 , 48 , 60 ], changed behavior [ 29 , 32 , 34 , 50 , 53 , 55 , 56 , 58 - 60 ], increased QoL [ 31 , 36 , 37 , 39 - 41 , 45 , 54 , 56 , 57 , 59 , 60 ], increased self-efficacy [ 28 , 35 , 36 , 41 , 47 ], increased social support [ 28 , 32 ], and reduced costs [ 34 ].…”