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Clinical Trials/NCT01734291
NCT01734291
Completed
N/A

Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression: A Randomized Controlled Trial

Nagoya City University1 site in 1 country49 target enrollmentOctober 1, 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Nagoya City University
Enrollment
49
Locations
1
Primary Endpoint
The change of total score of K6 of family members
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to examine the effectiveness of brief multifamily psychoeducation to relieve the psychological distress of families of patients with chronic major depression and to improve their family functioning.

Detailed Description

Major depressive disorder (MDD) is a long-lasting illness with significant effects on the patient's family, social life, and work life. Treatment failure results in a low recovery rate and frequent relapses. Relatives of patients with MDD are fraught with heavy psychosocial burden and show increased rates of depression and anxiety. Among relatives of patients with MDD, the patient's behavior and mood disturbance and relative's emotional distress were associated with the relatives' burden. Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder. This intervention has been shown to reduce the rates of relapse and hospitalization among individuals with psychotic disorders and is recognized as an evidenced-based treatment for psychotic disorder. Several randomized controlled trials have found that family psychoeducation is effective in enhancing the course of bipolar disorder. However, there are few studies on psychoeducation of families of patients with MDD. The purpose of this study is to examine the effectiveness of brief multifamily psychoeducation to relieve the psychological distress of families of patients with chronic major depression and to improve their family functioning, in a randomized controlled trial.

Registry
clinicaltrials.gov
Start Date
October 1, 2012
End Date
October 9, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fujika Katsuki

Associate Professor

Nagoya City University

Eligibility Criteria

Inclusion Criteria

  • Meets the criteria for Major Depressive Disorder (MDD) according to DSM-IV.
  • Receives antidepressant therapy.
  • The patient had the first episode of MDD more than one year ago.
  • Currently fulfills the diagnostic threshold for major depressive episode or partial remission.
  • The patient and their family member(s) are aged between 18 and 85 years.
  • The patient has lived with his/her family at the time of participating in this study and is expected to live with his/her family during the investigation period.

Exclusion Criteria

  • Patients who undergo electroconvulsive therapy (ECT) during the investigation period.
  • Patients who are at serious suicidal risk.

Outcomes

Primary Outcomes

The change of total score of K6 of family members

Time Frame: The base line, 8, 16 and 32

The K6 questionnaire is a six-item self-report questionnaire that was developed to screen for DSM-IV depressive and anxiety disorder.

Secondary Outcomes

  • The change of total score of Family Attitude Scale(FAS) of family members(The base line, 8, 16 and 32)

Study Sites (1)

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