Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatment family psychoeducation
Phase phase 2/phase 3
Sponsor Nagoya City University
Start date October 2012
End date March 2016
Trial size 54 participants
Trial identifier NCT01734291, ID24593499, NCUPsychiatricNursing001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Family psychoeducational therapy in addition to treatment as usual for the patients.
family psychoeducation
Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians
(Placebo Comparator)
Treatment as usual administered by physician and counseling administered by nurse.
family psychoeducation
Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians

Primary Outcomes

Measure
The change of total score of K6 of family members
time frame: The base line, 8, 16 and 32

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression: A Randomized Controlled Trial
Principal investigator Fujika Katsuki, Dr
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Nagoya City University.