Schema Therapy for Chronic Depression
- Conditions
- Chronic Depressive DisorderDysthymic Disorder
- Interventions
- Behavioral: Schema therapyBehavioral: Active monitoring
- Registration Number
- NCT03084744
- Lead Sponsor
- Institute for Health Economics and Policy, Japan
- Brief Summary
To compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care.
- Detailed 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%.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 64
- Persistent depressive disorder including chronic major depressive disorder and dysthymic 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Schema therapy Schema therapy Schema therapy in an individual format will be implemented by clinical psychologists. The treatment period will be 2 years with biweekly 50-minute sessions (up to 48 sessions). Active monitoring Active monitoring Active monitoring by telephone will be implemented by clinical psychologists. The treatment period will be 2 years with monthly 10-minute sessions (up to 24 sessions).
- Primary Outcome Measures
Name Time Method Treatment response (% change from baseline to at 104 weeks) 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.
- Secondary Outcome Measures
Name Time Method Change in self-rated depression severity 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.
Medical costs 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.
Remission 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 (24-item HAMD) 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 observer-rated depression severity (17-item HAMD) 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 self-rated quality of life Baseline, 52 weeks, 104 weeks Change in self-rated quality of life was defined as the change score of the EQ-5D-5L.
Trial Locations
- Locations (1)
Senzoku stress coping support office
🇯🇵Tokyo, Ota-ku, Japan