Schema Therapy for Chronic Depression
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|ClinicalTrials.gov Identifier: NCT03084744|
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : March 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Depressive Disorder Dysthymic Disorder||Behavioral: Schema therapy Behavioral: Active monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Outcomes Assessor)|
|Masking Description:||Outcome assessors of the primary outcome will be blinded to treatment assignments.|
|Official Title:||Senzoku Intervention of Schema Therapy for Aid and Recovery From Chronic Depression (SISTAR*CD)|
|Actual Study Start Date :||August 21, 2017|
|Estimated Primary Completion Date :||May 1, 2025|
|Estimated Study Completion Date :||May 1, 2025|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084744
|Contact: Yasuyuki Okumura, PhDemail@example.com|
|Contact: Emi Ito, PhDfirstname.lastname@example.org|
|Senzoku stress coping support office||Recruiting|
|Tokyo, Ota-ku, Japan, 145-0062|
|Contact: Emi Ito, PhD|
|Contact +81-3-5499-4970 email@example.com|
|Principal Investigator:||Yasuyuki Okumura, PhD||Institute for Health Economics and Policy|
|Principal Investigator:||Emi Ito, PhD||Senzoku Stress Coping Support Office|