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Schema Therapy for Chronic Depression

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ClinicalTrials.gov Identifier: NCT03084744
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Senzoku Stress Coping Support Office
Information provided by (Responsible Party):
Yasuyuki Okumura, Institute for Health Economics and Policy, Japan

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

Condition or disease Intervention/treatment Phase
Chronic Depressive Disorder Dysthymic Disorder Behavioral: Schema therapy Behavioral: Active monitoring Not Applicable

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%.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors of the primary outcome will be blinded to treatment assignments.
Primary Purpose: Treatment
Official Title: Senzoku Intervention of Schema Therapy for Aid and Recovery From Chronic Depression (SISTAR*CD)
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Treatment response (% change from baseline to at 104 weeks) [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Remission [ Time Frame: 104 weeks ]
    Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks.

  2. Change in observer-rated depression severity (17-item HAMD) [ Time Frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks ]
    Change in observer-rated depression severity was defined as the change score of the 17-item GRID-HAMD from baseline through 104 weeks.

  3. Change in observer-rated depression severity (24-item HAMD) [ Time Frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks ]
    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.

  4. Change in self-rated depression severity [ Time Frame: Baseline, 52 weeks, 104 weeks ]
    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.

  5. Change in self-rated quality of life [ Time Frame: Baseline, 52 weeks, 104 weeks ]
    Change in self-rated quality of life was defined as the change score of the EQ-5D-5L.

  6. Medical costs [ Time Frame: baseline through 104 weeks (assessed at each session) ]
    The cumulative medical costs during 104 weeks for the utilization of medical services will be assessed at each session.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084744


Contacts
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Contact: Yasuyuki Okumura, PhD +81-3-3506-8529 yokumura@blue.zero.jp
Contact: Emi Ito, PhD +81-3-5499-4970 emiito@stress-coping.com

Locations
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Japan
Senzoku stress coping support office Recruiting
Tokyo, Ota-ku, Japan, 145-0062
Contact: Emi Ito, PhD         
Contact    +81-3-5499-4970    emiito@stress-coping.com   
Sponsors and Collaborators
Institute for Health Economics and Policy, Japan
Senzoku Stress Coping Support Office
Investigators
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Principal Investigator: Yasuyuki Okumura, PhD Institute for Health Economics and Policy
Principal Investigator: Emi Ito, PhD Senzoku Stress Coping Support Office

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Responsible Party: Yasuyuki Okumura, Principal Investigator, Institute for Health Economics and Policy, Japan
ClinicalTrials.gov Identifier: NCT03084744     History of Changes
Other Study ID Numbers: 16207
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be available to other researchers within 3 years after the publication of the primary paper.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Dysthymic Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders