Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734291
• Other study ID #: NCUPsychiatricNursing001
• Secondary ID: ID24593499
• Status: Completed
• Phase: N/A
• First received: November 21, 2012
• Last updated: April 3, 2017
• Start date: October 1, 2012
• Est. completion date: October 9, 2016

Study information

• Verified date: April 2017
• Source: Nagoya City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 9, 2016
• Est. primary completion date: June 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Family psychoeducation
Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians

Locations

Country	Name	City	State
Japan	Fujika Katsuki	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Nagoya City University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Katsuki F, Takeuchi H, Watanabe N, Shiraishi N, Maeda T, Kubota Y, Suzuki M, Yamada A, Akechi T. Multifamily psychoeducation for improvement of mental health among relatives of patients with major depressive disorder lasting more than one year: study protocol for a randomized controlled trial. Trials. 2014 Aug 12;15:320. doi: 10.1186/1745-6215-15-320. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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