Schema Therapy for Chronic Depression

Dysthymic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03084744
• Other study ID #: 16207
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2017
• Last updated: March 7, 2018
• Start date: August 21, 2017
• Est. completion date: May 1, 2025

Study information

• Verified date: March 2018
• Source: Institute for Health Economics and Policy, Japan
• Contact: Yasuyuki Okumura, PhD
• Phone: +81-3-3506-8529
• Email: yokumura[@]blue.zero.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Depressive Disorder
• Depression
• Depressive Disorder
• Disease
• Dysthymic Disorder

Intervention

Behavioral:
• Schema therapy
Schema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists.
• Active monitoring
Active tele-monitoring by clinical psychologists.

Locations

Country	Name	City	State
Japan	Senzoku stress coping support office	Tokyo	Ota-ku

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Health Economics and Policy, Japan	Senzoku Stress Coping Support Office

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Remission	Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks.	104 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)