Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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 1, 2014
Last verified: October 2014

November 21, 2012
October 1, 2014
October 2012
July 2015   (final data collection date for primary outcome measure)
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.
The 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.
Complete list of historical versions of study NCT01734291 on ClinicalTrials.gov Archive Site
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).
The 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).
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Behavioral: Family psychoeducation
Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians
  • Active Comparator: Family psychoeducation plus TAU
    Family psychoeducational therapy in addition to treatment as usual for the patients.
    Intervention: Behavioral: Family psychoeducation
  • Placebo Comparator: Treatment as usual(TAU)
    Treatment as usual administered by physician and counseling administered by nurse.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2015
July 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Fujika Katsuki, Dr +81-52-853-8048 katsuki@med.nagoya-cu.ac.jp
Japan
 
NCT01734291
NCUPsychiatricNursing001, ID24593499
No
Fujika Katsuki, Nagoya City University
Nagoya City University
Not Provided
Principal Investigator: Fujika Katsuki, Dr Nagoya City University, School of Nursing
Nagoya City University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP