Schema Therapy for Chronic Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-21

Study Completion Date

2025-05-01

Brief Summary

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

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Detailed Description

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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

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Chronic Depressive Disorder Dysthymic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors of the primary outcome will be blinded to treatment assignments.

Study Groups

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Schema therapy

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).

Group Type EXPERIMENTAL

Schema therapy

Intervention Type BEHAVIORAL

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

Active monitoring

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).

Group Type PLACEBO_COMPARATOR

Active monitoring

Intervention Type BEHAVIORAL

Active tele-monitoring by clinical psychologists.

Interventions

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Schema therapy

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

Intervention Type BEHAVIORAL

Active monitoring

Active tele-monitoring by clinical psychologists.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No