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| Name | Class |
|---|---|
| Senzoku Stress Coping Support Office | UNKNOWN |
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To compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Schema therapy | Experimental | 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 | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Schema therapy | Behavioral | Schema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasuyuki Okumura, PhD | Contact | +81-3-3506-8529 | yokumura@blue.zero.jp | |
| Emi Ito, PhD | Contact | +81-3-5499-4970 | emiito@stress-coping.com |
| Name | Affiliation | Role |
|---|---|---|
| Yasuyuki Okumura, PhD | Institute for Health Economics and Policy | Principal Investigator |
| Emi Ito, PhD | Senzoku Stress Coping Support Office | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Senzoku stress coping support office | Recruiting | Tokyo | Ota-ku | 145-0062 | Japan |
IPD will be available to other researchers within 3 years after the publication of the primary paper.
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| ID | Term |
|---|---|
| D019263 | Dysthymic Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000081843 | Schema Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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Outcome assessors of the primary outcome will be blinded to treatment assignments.
| Active monitoring | Behavioral | Active tele-monitoring by clinical psychologists. |
|
| 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) |