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Clinical Trial Summary

To compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care.


Clinical Trial Description

A randomized, assessor-blind, single center, superiority trial will be conducted. Participants will be referred to clinical psychologists in a private counseling office (Senzoku Stress Coping Support Office, in Japan). Eligible participants will be women with chronic depression receiving psychiatric care. Participants will receive schema therapy or active monitoring during 2 years. Primary outcome will be treatment response. A total sample size of 64 (32 in each group) would be required to provide 80% power at a 2-sided significance level of 5% to detect a risk difference of 35% (response rate: 55% for schema therapy vs. 20% for active monitoring), assuming a dropout rate of 10%. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03084744
Study type Interventional
Source Institute for Health Economics and Policy, Japan
Contact Yasuyuki Okumura, PhD
Phone +81-3-3506-8529
Email yokumura@blue.zero.jp
Status Recruiting
Phase N/A
Start date August 21, 2017
Completion date May 1, 2025

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