Schema Therapy for Chronic Depression

Last updated: March 7, 2018
Sponsor: Institute for Health Economics and Policy, Japan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Depression (Treatment-resistant)

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT03084744
16207
  • Ages 40-65
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Persistent depressive disorder including chronic major depressive disorder anddysthymic disorder assessed by the Structured Clinical Interview for DSM

  • Scores of at least 14 on the GRID-HAMD

  • Psychiatric treatment duration for depression of at least 3 years

Exclusion

Exclusion Criteria:

  • Psychiatric hospitalization within 30 days prior to the enrollment

  • Ineligible to receive the protocol treatment during 2 years

  • Schizophrenia

  • Bipolar disorders

  • Intellectual disabilities

  • Neurocognitive disorders

  • Substance-related disorders

Study Design

Total Participants: 64
Study Start date:
August 21, 2017
Estimated Completion Date:
May 01, 2025

Study 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%.

Connect with a study center

  • Senzoku stress coping support office

    Tokyo, Ota-ku 145-0062
    Japan

    Active - Recruiting

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