Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Family psychoeducation

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 467-8601
      • Fujika Katsuki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nagoya City University
• Investigators: Principal Investigator: Fujika Katsuki, Dr, Nagoya City University, School of Nursing

Publications and helpful links

General Publications

• 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.
• Katsuki F, Takeuchi H, Inagaki T, Maeda T, Kubota Y, Shiraishi N, Tabuse H, Kato T, Yamada A, Watanabe N, Akechi T, Furukawa TA. Brief multifamily Psychoeducation for family members of patients with chronic major depression: a randomized controlled trial. BMC Psychiatry. 2018 Jun 22;18(1):207. doi: 10.1186/s12888-018-1788-6.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): June 20, 2016
• Study Completion (Actual): October 9, 2016

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: November 21, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Major depressive disorder; Family psychoeducation; Family burden
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: NCUPsychiatricNursing001; ID24593499 (Other Grant/Funding Number: Grants-in-Aid for Scientific Research)