Guided Internet-Based Cognitive Behavioral Therapy for Japanese Patients with Obsessive-Compulsive Disorder: A Protocol of the Randomized Controlled Trial (Preprint) [post]

Kazuki Matsumoto, Sayo Hamatani, Takuya Makino, Taku Uemura, Futoshi Suzuki, Seina Shinno, Tomoki Ikai, Hiroyuki Hayashi, Chihiro Sutoh, Eiji Shimizu
2020 unpublished
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
more » ... 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. CLINICALTRIAL UMIN: 000044422
doi:10.2196/preprints.18216 fatcat:wvuutnumijf2xlj4cnszc2adi4