Clinical trial NCT03084744: Schema Therapy for Chronic Depression
Official title: Senzoku Intervention of Schema Therapy for Aid and Recovery From Chronic Depression (SISTAR*CD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Depressive Disorder
Dysthymic Disorder
Lead sponsor: Institute for Health Economics and Policy, Japan
Sponsor class: OTHER
Collaborators: name: Senzoku Stress Coping Support Office
First posted: 2017-03-21
Enrollment: 64
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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%.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment response (% change from baseline to at 104 weeks)
timeFrame: Baseline, 104 weeks
Secondary outcomes:
measure: Remission
timeFrame: 104 weeks
measure: Change in observer-rated depression severity (17-item HAMD)
timeFrame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks
measure: Change in observer-rated depression severity (24-item HAMD)
timeFrame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks
measure: Change in self-rated depression severity
timeFrame: Baseline, 52 weeks, 104 weeks
measure: Change in self-rated quality of life
timeFrame: Baseline, 52 weeks, 104 weeks
measure: Medical costs
timeFrame: baseline through 104 weeks (assessed at each session)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Senzoku stress coping support office
state: Ota-ku
Study officials:
affiliation: Institute for Health Economics and Policy
name: Yasuyuki Okumura, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Senzoku Stress Coping Support Office
name: Emi Ito, PhD
role: PRINCIPAL_INVESTIGATOR
References: