Schema Therapy for Chronic Depression

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

Detailed Description
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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%.

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

Conditions
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Chronic Depressive Disorder, Dysthymic Disorder

Intervention / Treatment
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* Behavioral: Schema therapy
* Behavioral: Active monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated into two groups using a web-based central allocation system. This system will confirm allocation concealment and random sequence generation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Schema therapy<br>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<br>* Schema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists.<br>|
| Placebo Comparator: Active monitoring<br>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<br>* Active tele-monitoring by clinical psychologists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response (% change from baseline to at 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. | Baseline, 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission | Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks. | 104 weeks | 
| Change in observer-rated depression severity (17-item HAMD) | Change in observer-rated depression severity was defined as the change score of the 17-item GRID-HAMD from baseline through 104 weeks. | Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks | 
| Change in observer-rated depression severity (24-item HAMD) | 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. | Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks | 
| Change in self-rated depression severity | 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. | Baseline, 52 weeks, 104 weeks | 
| Change in self-rated quality of life | Change in self-rated quality of life was defined as the change score of the EQ-5D-5L. | Baseline, 52 weeks, 104 weeks | 
| Medical costs | The cumulative medical costs during 104 weeks for the utilization of medical services will be assessed at each session. | baseline through 104 weeks (assessed at each session) |