Schema Therapy for Chronic Depression
Study Details
Study Description
Brief Summary
To compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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%.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Behavioral: Schema therapy
Schema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists.
|
| Placebo Comparator: 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). |
Behavioral: Active monitoring
Active tele-monitoring by clinical psychologists.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 (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 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 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Persistent depressive disorder including chronic major depressive disorder and dysthymic disorder assessed by the Structured Clinical Interview for DSM
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Scores of at least 14 on the GRID-HAMD
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Psychiatric treatment duration for depression of at least 3 years
Exclusion Criteria:
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Psychiatric hospitalization within 30 days prior to the enrollment
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Ineligible to receive the protocol treatment during 2 years
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Schizophrenia
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Bipolar disorders
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Intellectual disabilities
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Neurocognitive disorders
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Substance-related disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Senzoku stress coping support office | Tokyo | Ota-ku | Japan | 145-0062 |
Sponsors and Collaborators
- Institute for Health Economics and Policy, Japan
- Senzoku Stress Coping Support Office
Investigators
- Principal Investigator: Yasuyuki Okumura, PhD, Institute for Health Economics and Policy
- Principal Investigator: Emi Ito, PhD, Senzoku Stress Coping Support Office
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16207