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临床试验/NCT01734291
NCT01734291已完成不适用

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

Nagoya City University2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2012年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
The change of total score of K6 of family members

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients who undergo electroconvulsive therapy (ECT) during the investigation period.
  • Patients who are at serious suicidal risk.

结局指标

主要结局

The change of total score of K6 of family members

时间窗: 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.

次要结局

  • The change of total score of Family Attitude Scale(FAS) of family members(The base line, 8, 16 and 32)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fujika Katsuki

Associate Professor

Nagoya City University

研究点 (2)

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