Schema Therapy for Chronic Depression

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

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%.

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