Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Family psychoeducation

• Registration Number: NCT01734291
• Lead Sponsor: Nagoya City University

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.

Study Timeline

• Study Start: 2012-10-01
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-27
• Primary Completion: 2016-06-20
• Study Completion: 2016-10-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Meets the criteria for Major Depressive Disorder (MDD) according to DSM-IV.
2. Receives antidepressant therapy.
3. The patient had the first episode of MDD more than one year ago.
4. Currently fulfills the diagnostic threshold for major depressive episode or partial remission.
5. The patient and their family member(s) are aged between 18 and 85 years.
6. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family psychoeducation plus TAU	Family psychoeducation	Family psychoeducational therapy in addition to treatment as usual for the patients.
Treatment as usual(TAU)	Family psychoeducation	Treatment as usual administered by physician and counseling administered by nurse.

Primary Outcome Measures

Name	Time	Method
The change of total score of K6 of family members	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 Outcome Measures

Name	Time	Method
The change of total score of Family Attitude Scale(FAS) of family members	The base line, 8, 16 and 32	The Family Attitude Scale(FAS) is a 30-item self report inventory and measures families' Expressed Emotion(EE).

Trial Locations

Locations (1)

Fujika Katsuki; 🇯🇵 Nagoya, Aichi, Japan