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Accepted for/Published in: Journal of Medical Internet Research

Date Submitted: Apr 11, 2018
Open Peer Review Period: Apr 12, 2018 - Aug 14, 2018
Date Accepted: Aug 14, 2018
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Web-Based Cognitive Behavioral Therapy Blended With Face-to-Face Sessions for Major Depression: Randomized Controlled Trial

Nakao S, Nakagawa A, Oguchi Y, Mitsuda D, Kato N, Nakagawa Y, Tamura N, Kudo Y, Abe T, Hiyama M, Iwashita S, Ono Y, Mimura M

Web-Based Cognitive Behavioral Therapy Blended With Face-to-Face Sessions for Major Depression: Randomized Controlled Trial

J Med Internet Res 2018;20(9):e10743

DOI: 10.2196/10743

PMID: 30249583

PMCID: 6231848

Web-Based Cognitive Behavioral Therapy Blended With Face-to-Face Sessions for Major Depression: Randomized Controlled Trial

  • Shigetsugu Nakao; 
  • Atsuo Nakagawa; 
  • Yoshiyo Oguchi; 
  • Dai Mitsuda; 
  • Noriko Kato; 
  • Yuko Nakagawa; 
  • Noriko Tamura; 
  • Yuka Kudo; 
  • Takayuki Abe; 
  • Mitsunori Hiyama; 
  • Satoru Iwashita; 
  • Yutaka Ono; 
  • Masaru Mimura

ABSTRACT

Background:

Meta-analyses of several 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 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 at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended 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, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 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 posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment 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:

We randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the 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<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009.

Conclusions:

Although our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL)


 Citation

Please cite as:

Nakao S, Nakagawa A, Oguchi Y, Mitsuda D, Kato N, Nakagawa Y, Tamura N, Kudo Y, Abe T, Hiyama M, Iwashita S, Ono Y, Mimura M

Web-Based Cognitive Behavioral Therapy Blended With Face-to-Face Sessions for Major Depression: Randomized Controlled Trial

J Med Internet Res 2018;20(9):e10743

DOI: 10.2196/10743

PMID: 30249583

PMCID: 6231848

Per the author's request the PDF is not available.

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