Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 12, 2020
Open Peer Review Period: Feb 12, 2020 - Mar 12, 2020
Date Accepted: Mar 23, 2020
Date Submitted to PubMed: May 22, 2020
(closed for review but you can still tweet)
Guided Internet-Based Cognitive Behavioral Therapy for Japanese Patients with Obsessive-Compulsive Disorder: A Protocol of the Randomized Controlled Trial
ABSTRACT
Background:
Cognitive behavioral therapy (CBT) for obsessive-compulsive disease (OCD) has been established, but access to CBT in Japan is limited. Internet-based cognitive behavioral therapy (ICBT) may improve treatment accessibility and sufficiently improve obsessive-compulsive symptoms. Because there are few randomized controlled trials, it is necessary to examine the effectiveness of ICBT in patients with OCD. We designed a randomized controlled trial (RCT) protocol between guided ICBT and the control group in Japanese patients with OCD.
Objective:
We reported a protocol for a randomized controlled trial of ICBT in Japanese patients with OCD.
Methods:
RCT comprised two parallel groups (ICBT and UC) consisting of 15 participants each (n=30) diagnosed with OCD. We will evaluate the effectiveness of twelve intervention weeks. The primary outcome of symptoms’ severity will be the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Secondary outcomes include the Obsessive-Compulsive Inventory (OCI), Beck Anxiety Inventory (BAI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Working Alliance Inventory-Short Form (WAI-SF), and quality of life in Euro Qol-5D. All measures will be assessed at weeks 0 (baseline) and 12 (follow-up). In the statistical analysis comparing treatment effects, the least-squares means and their 95% CIs will be estimated by analysis of covariance (ANCOVA) with the change in total outcomes' scores at week 12. All comparisons are planned, and all P values will be two-sided. P values < 0.05 will be considered statistically significant.
Results:
The study will be implemented from January 2020 to March 2021, and results are expected to be available in mid-2021.
Conclusions:
The protocol suggested that the way to reduce nonbeneficial invasive treatments for OCD patients, and a systematic approach to improve access to CBT in Japan. Clinical Trial: UMIN: 000044422
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