Web-based Cognitive Behavioral Therapy Blended with Face-to-Face Sessions for Major Depression: a Randomized Clinical Trial (Preprint)
Authors: Nakao Shigetsugu , Nakagawa Atsuo , Oguchi Yoshiyo , Mitsuda Dai , Kato Noriko , Nakagawa Yuko , Tamura Noriko , Kudo Yuka , Abe Takayuki , Hiyama Mitsunori , Iwashita Satoru , Ono Yutaka , Mimura Masaru 
Published: April 2018

BACKGROUND

Meta-analyses of a large number of randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem.

OBJECTIVE

This study aimed to evaluate the effectiveness of a web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications.

METHODS

A 12-week, assessor-masked, parallel-group, waiting-list controlled, randomized trial was conducted in three medical institutions located in Tokyo. Outpatients aged 20–65 years with a primary diagnosis of major depression (taking one or more antidepressant medications at an adequate dose for ≥ 6 weeks, 17-item GRID-Hamilton Depression Rating Scale [GRID-HAMD] score ≥ 14) were randomly assigned (1:1) to blend CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, consisting of a web-based program and twelve 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which was approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides sixteen 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to post-treatment (at 12 weeks). Additionally, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the post-treatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures.

RESULTS

A total of 40 participants were randomized to either blend CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol, and all were included in the intention-to-treat analyses. Participants in the blend CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in GRID-HAMD score, than those in the waiting-list group (−8.9 points vs. −3.0 points; mean between-group difference = −5.95; 95% CI, −9.53 to −2.37; p =0.0002). The follow-up effects within the blend CBT group, as measured by GRID-HAMD score, was sustained at 3-months follow-up (week 24) after treatment (week 12) (post-treatment: 9.4 ± 5.2 vs. follow-up: 7.2 ± 5.7, p= 0.009).

CONCLUSIONS

Although our findings need to be confirmed in larger and longer-term studies with active controls, the present findings suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who were unresponsive to antidepressant medications.

CLINICALTRIAL

Japanese Clinical Trials Registry UMIN Clinical Trials Registry Identifier: UMIN000009242.