Schema Therapy for Chronic Depression

Institute for Health Economics and Policy, Japan64 enrolled

Overview

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%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Depressive Disorder Dysthymic Disorder

Interventions

Schema therapyBEHAVIORAL

Schema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists.

Active monitoringBEHAVIORAL

Active tele-monitoring by clinical psychologists.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Senzoku stress coping support office

Tokyo, Ota-ku, Japan

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 104 weeks

Secondary Outcomes

Remission

Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks.

Time frame: 104 weeks

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.

Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks

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.

Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks

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.

Time frame: Baseline, 52 weeks, 104 weeks

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.

Time frame: Baseline, 52 weeks, 104 weeks

Central Contacts

Yasuyuki Okumura, PhD

CONTACT

+81-3-3506-8529 yokumura@blue.zero.jp

Emi Ito, PhD

CONTACT

+81-3-5499-4970 emiito@stress-coping.com

Data from ClinicalTrials.gov

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