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Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Family psychoeducation
Sponsored by
Nagoya City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Family psychoeducation, Major depressive disorder, Family burden

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fujika Katsuki

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Family psychoeducation plus TAU

Treatment as usual(TAU)

Arm Description

Family psychoeducational therapy in addition to treatment as usual for the patients.

Treatment as usual administered by physician and counseling administered by nurse.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
November 21, 2012
Last Updated
April 3, 2017
Sponsor
Nagoya City University
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1. Study Identification

Unique Protocol Identification Number
NCT01734291
Brief Title
Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression
Official Title
Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
June 20, 2016 (Actual)
Study Completion Date
October 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nagoya City University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Family psychoeducation, Major depressive disorder, Family burden

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family psychoeducation plus TAU
Arm Type
Active Comparator
Arm Description
Family psychoeducational therapy in addition to treatment as usual for the patients.
Arm Title
Treatment as usual(TAU)
Arm Type
Placebo Comparator
Arm Description
Treatment as usual administered by physician and counseling administered by nurse.
Intervention Type
Behavioral
Intervention Name(s)
Family psychoeducation
Intervention Description
Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians
Primary Outcome Measure Information:
Title
The change of total score of K6 of family members
Description
The K6 questionnaire is a six-item self-report questionnaire that was developed to screen for DSM-IV depressive and anxiety disorder.
Time Frame
The base line, 8, 16 and 32
Secondary Outcome Measure Information:
Title
The change of total score of Family Attitude Scale(FAS) of family members
Description
The Family Attitude Scale(FAS) is a 30-item self report inventory and measures families' Expressed Emotion(EE).
Time Frame
The base line, 8, 16 and 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets the criteria for Major Depressive Disorder (MDD) according to DSM-IV. Receives antidepressant therapy. The patient had the first episode of MDD more than one year ago. Currently fulfills the diagnostic threshold for major depressive episode or partial remission. The patient and their family member(s) are aged between 18 and 85 years. 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: Patients who undergo electroconvulsive therapy (ECT) during the investigation period. Patients who are at serious suicidal risk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fujika Katsuki, Dr
Organizational Affiliation
Nagoya City University, School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujika Katsuki
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8601
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25118129
Citation
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.
Results Reference
background
PubMed Identifier
29929495
Citation
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.
Results Reference
derived

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Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

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