Clinical Trial: Schema Therapy for Chronic Depression

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Senzoku Intervention of Schema Therapy for Aid and Recovery From Chronic Depression (SISTAR*CD)

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

Detailed Summary: 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%.
Sponsor: Institute for Health Economics and Policy, Japan

Current Primary Outcome: Treatment response (% change from baseline to at 104 weeks) [ Time Frame: Baseline, 104 weeks ]

Treatment response was defined as 50% or greater reduction in depressive symptoms (the 17-item GRID-Hamilton Depression Rating Scale; GRID-HAMD) at 104 weeks compared with baseline. The GRID-HAMD will be administered by clinical psychologists who will be blinded to treatment assignments.


Original Primary Outcome: Treatment response (% change from baseline to at 104 weeks) [ Time Frame: 104 weeks ]

Treatment response was defined as 50% or greater reduction in depressive symptoms (the 17-item GRID-Hamilton Depression Rating Scale; GRID-HAMD) at 104 weeks compared with baseline. The 17-item GRID-HAMD will be administered by clinical psychologists who will be blinded to treatment assignments. The 17-item GRID-HAMD will be assessed at baseline, 26 weeks, 52 weeks, 78 weeks, and 104 weeks.


Current Secondary Outcome:

  • Remission [ Time Frame: 104 weeks ]
    Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks.
  • Change in observer-rated depression severity (17-item HAMD) [ Time Frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks ]
    Change in observer-rated depression severity was defined as the change score of the 17-item GRID-HAMD from baseline through 104 weeks.
  • Change in observer-rated depression severity (24-item HAMD) [ Time Frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks ]
    Change in observer-rated depression severity was defined as the change score of the 24-item GRID-HAMD from baseline through 104 weeks. The 24-item GRID-HAMD will be administered by clinical psychologists who will be blinded to treatment assignments.
  • Change in self-rated depression severity [ Time Frame: Baseline, 52 weeks, 104 weeks ]
    Change in self-rated depression severity was defined as the change score of the Beck Depression Scale-II (BDI-II) from baseline through 104 weeks.
  • Change in self-rated quality of life [ Time Frame: Baseline, 52 weeks, 104 weeks ]
    Change in self-rated quality of life was defined as the change score of the EQ-5D-5L.
  • Medical costs [ Time Frame: baseline through 104 weeks (assessed at each session) ]
    The cumulative medical costs during 104 weeks for the utilization of medical services will be assessed at each session.


Original Secondary Outcome:

  • Remission [ Time Frame: 104 weeks ]
    Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks.
  • Change in observer-rated depression severity (17-item HAMD) [ Time Frame: baseline through 104 weeks ]
    Change in observer-rated depression severity was defined as the change score of the 17-item GRID-HAMD from baseline through 104 weeks.
  • Change in observer-rated depression severity (24-item HAMD) [ Time Frame: baseline through 104 weeks ]
    Change in observer-rated depression severity was defined as the change score of the 24-item GRID-HAMD from baseline through 104 weeks. The 24-item GRID-HAMD will be administered by clinical psychologists who will be blinded to treatment assignments. The 24-item GRID-HAMD will be assessed at baseline, 26 weeks, 52 weeks, 78 weeks, and 104 weeks.
  • Change in self-rated depression severity [ Time Frame: baseline through 104 weeks ]
    Change in self-rated depression severity was defined as the change score of the Beck Depression Scale-II (BDI-II) from baseline through 104 weeks. The BDI-II will be assessed at baseline, 52 weeks, and 104 weeks.
  • Change in self-rated quality of life [ Time Frame: baseline through 104 weeks ]
    Change in self-rated quality of life was defined as the change score of the EQ-5D-5L. The EQ-5D-5L will be assessed at baseline, 52 weeks, and 104 weeks.
  • Medical costs [ Time Frame: baseline through 104 weeks ]
    The cumulative medical costs during 104 weeks for the utilization of medical services will be assessed at each session.


Information By: Institute for Health Economics and Policy, Japan

Dates:
Date Received: March 2, 2017
Date Started: May 1, 2017
Date Completion: May 1, 2025
Last Updated: March 22, 2017
Last Verified: March 2017