Schema Therapy for Chronic Depression

Senzoku Intervention of Schema Therapy for Aid and Recovery From Chronic Depression (SISTAR*CD)

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

Study Overview

• Status: Recruiting
• Conditions: Dysthymic Disorder; Chronic Depressive Disorder
• Intervention / Treatment: Behavioral: Schema therapy; Behavioral: Active monitoring

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%.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasuyuki Okumura, PhD; Phone Number: +81-3-3506-8529; Email: yokumura@blue.zero.jp
• Study Contact Backup: Name: Emi Ito, PhD; Phone Number: +81-3-5499-4970; Email: emiito@stress-coping.com

Study Locations

• Japan
  • Ota-ku
    • Tokyo, Ota-ku, Japan, 145-0062
      • Recruiting
      • Senzoku stress coping support office
      • Contact: Emi Ito, PhD
      • Contact: Phone Number: +81-3-5499-4970; Email: emiito@stress-coping.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Behavioral: Schema therapy; Schema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists.
PLACEBO_COMPARATOR: 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).	Behavioral: Active monitoring; Active tele-monitoring by clinical psychologists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission	Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks.	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.	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.	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.	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.	Baseline, 52 weeks, 104 weeks
Medical costs	The cumulative medical costs during 104 weeks for the utilization of medical services will be assessed at each session.	baseline through 104 weeks (assessed at each session)

Collaborators and Investigators

• Sponsor: Institute for Health Economics and Policy, Japan
• Collaborators: Senzoku Stress Coping Support Office
• Investigators: Principal Investigator: Yasuyuki Okumura, PhD, Institute for Health Economics and Policy; Principal Investigator: Emi Ito, PhD, Senzoku stress coping support office

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2017
• Primary Completion (ANTICIPATED): May 1, 2025
• Study Completion (ANTICIPATED): May 1, 2025

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (ACTUAL): March 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Disease; Dysthymic Disorder
• Other Study ID Numbers: 16207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be available to other researchers within 3 years after the publication of the primary paper.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No