Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Family psychoeducation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Family psychoeducation plus TAU<br>Family psychoeducational therapy in addition to treatment as usual for the patients. | Behavioral: Family psychoeducation<br>* Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians<br>|
| Placebo Comparator: Treatment as usual(TAU)<br>Treatment as usual administered by physician and counseling administered by nurse. | Behavioral: Family psychoeducation<br>* Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of total score of K6 of family members | The K6 questionnaire is a six-item self-report questionnaire that was developed to screen for DSM-IV depressive and anxiety disorder. | The base line, 8, 16 and 32 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family psychoeducation, Major depressive disorder, Family burden