NCT03084744

Schema Therapy for Chronic Depression

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Institute for Health Economics and Policy, Japan · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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%.

Conditions

• Chronic Depressive Disorder
• Dysthymic Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Schema therapy	Schema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists.
BEHAVIORAL	Active monitoring	Active tele-monitoring by clinical psychologists.

Timeline

• Start date: 2017-08-21
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2017-03-21
• Last updated: 2018-03-08

Locations

1 site across 1 country: Japan