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Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734291
First Posted: November 27, 2012
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fujika Katsuki, Nagoya City University
  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
Major Depressive Disorder Behavioral: Family psychoeducation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression: A Randomized Controlled Trial

Further study details as provided by Fujika Katsuki, 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 ]
    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 ]
    The Family Attitude Scale(FAS) is a 30-item self report inventory and measures families' Expressed Emotion(EE).


Enrollment: 49
Actual Study Start Date: October 1, 2012
Study Completion Date: October 9, 2016
Primary Completion Date: June 20, 2016 (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.
Behavioral: Family psychoeducation
Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734291


Locations
Japan
Fujika Katsuki
Nagoya, Aichi, Japan, 467-8601
Sponsors and Collaborators
Nagoya City University
Investigators
Principal Investigator: Fujika Katsuki, Dr Nagoya City University, School of Nursing
  More Information

Publications:
Responsible Party: Fujika Katsuki, Associate Professor, Nagoya City University
ClinicalTrials.gov Identifier: NCT01734291     History of Changes
Other Study ID Numbers: NCUPsychiatricNursing001
ID24593499 ( Other Grant/Funding Number: Grants-in-Aid for Scientific Research )
First Submitted: November 21, 2012
First Posted: November 27, 2012
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Fujika Katsuki, 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