Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Nagoya City University
Sponsor:
Information provided by (Responsible Party):
Fujika Katsuki, Nagoya City University
ClinicalTrials.gov Identifier:
NCT01734291
First received: November 21, 2012
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Behavioral: Family psychoeducation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Nagoya City University:

Primary Outcome Measures:
  • The change of total score of K6 of family members [ Time Frame: The base line, 8, 16 and 32 ] [ Designated as safety issue: No ]
    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:
  • The change of total score of Family Attitude Scale(FAS) of family members [ Time Frame: The base line, 8, 16 and 32 ] [ Designated as safety issue: No ]
    The Family Attitude Scale(FAS) is a 30-item self report inventory and measures families' Expressed Emotion(EE).


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734291

Contacts
Contact: Fujika Katsuki, Dr +81-52-853-8048 katsuki@med.nagoya-cu.ac.jp

Locations
Japan
Fujika Katsuki Recruiting
Nagoya, Aichi, Japan, 467-8601
Contact: Fujika Katsuki, Dr    +81-52-853-8048    katsuki@med.nagoya-cu.ac.jp   
Contact: Norio Watanabe, Dr       noriow@med.nagoya-cu.ac.jp   
Sponsors and Collaborators
Nagoya City University
Investigators
Principal Investigator: Fujika Katsuki, Dr Nagoya City University, School of Nursing
  More Information

No publications provided

Responsible Party: Fujika Katsuki, Associate Professor, Nagoya City University
ClinicalTrials.gov Identifier: NCT01734291     History of Changes
Other Study ID Numbers: NCUPsychiatricNursing001, ID24593499
Study First Received: November 21, 2012
Last Updated: October 18, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nagoya City University:
Family psychoeducation
Major depressive disorder
Family burden

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014