Schema Therapy for Chronic Depression

NCT03084744 | Unknown DMC

• 1 other identifier: 16207
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Depressive Disorder; Dysthymic Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 104 weeks

Secondary Outcomes (6)

• Remission

  104 weeks

• Change in observer-rated depression severity (17-item HAMD)

  Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks

• Change in observer-rated depression severity (24-item HAMD)

  Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks

• Change in self-rated depression severity

  Baseline, 52 weeks, 104 weeks

• Change in self-rated quality of life

  Baseline, 52 weeks, 104 weeks

Study Arms (2)

Schema therapy

EXPERIMENTAL

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).

Behavioral: Schema therapy

Active monitoring

PLACEBO COMPARATOR

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).

Behavioral: Active monitoring

Interventions

Schema therapy BEHAVIORAL

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

Schema therapy

Active monitoring BEHAVIORAL

Active tele-monitoring by clinical psychologists.

Active monitoring

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Health Economics and Policy, Japan: lead
• Senzoku Stress Coping Support Office: collaborator

Study Sites (1)

Senzoku stress coping support office

Tokyo, Ota-ku, 145-0062, Japan

RECRUITING

MeSH Terms

Conditions

Dysthymic Disorder

Interventions

Schema Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yasuyuki Okumura, PhD

  Institute for Health Economics and Policy

  PRINCIPAL INVESTIGATOR

• Emi Ito, PhD

  Senzoku Stress Coping Support Office

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors of the primary outcome will be blinded to treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 21, 2017
• Study Start: August 21, 2017
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 8, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)