Schema Therapy for Chronic Depression

Institute for Health Economics and Policy, Japan

Status: Enrolling

Conditions: Dysthymic Disorder; Chronic Depressive Disorder

Treatments: Behavioral: Schema therapy; Behavioral: Active monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03084744

16207

Details and patient eligibility

About

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

Full 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%.

Enrollment: 64 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

64 participants in 2 patient groups, including a placebo group

Schema therapy

Experimental group

Description:

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).

Treatment:

Behavioral: Schema therapy

Active monitoring

Placebo Comparator group

Description:

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).

Treatment:

Behavioral: Active monitoring