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Completed

NCT Number: NCT01734291

Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujika Katsuki

Nagoya, Aichi-ken, 467-8601, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family Psychoeducation

Behavioral

Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians

Primary outcomes

  1. 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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Nagoya City University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2012
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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