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临床试验/ChiCTR-TCS-14004601
ChiCTR-TCS-14004601已完成4 期

行為激活對輕微抑鬱的療效研究

HMRF1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2014年6月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
230
试验地点
1
主要终点
Reduction of self-reported depressive symptoms

研究概览

简要总结

行為激活對輕微抑鬱的療效

研究设计

研究类型
干预性研究
主要目的
随机平行对照
盲法
Single

入排标准

年龄范围
18 至 —(—)
性别
All

入选标准

  • Aged 18 years or above;
  • Score 5-9 by Patient Health Questionnaire depression scale (PHQ-9).

排除标准

  • major depression within the past 6 months;
  • lifetime history of other psychiatric disorders including generalized anxiety disorder, psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, presence of serious suicidal risk and medical illness with a prognosis of less than 6 months to live;
  • patients who are receiving current treatment (taking antidepressants or other psychotropic medications or enrolled in any form of psychological interventions) for any depressive disorders or symptoms.

研究组 & 干预措施

Behavioral Activation

Behavioural activation: The Martell and Colleagues 2010 protocol will be used for the content of group BA intervention due to its established efficacy. The objective of the BA intervention is to identify, promote and reinforce activities and circumstances that are consistent with each participant’s long term goals.

Behavioral Activation (to be continued)

Specific content of the group BA will include psychoeducation with respect to well-being, setting both short and long term goals, the self-monitoring of activity and mood using activity logs to recognize the association between specific activities and mood,

Care As Usual

Participants assigned to the CAU will receive their medical care from the doctors who work in the general outpatient clinics. They are not referred to mental health intervention but receive active monitoring or regular minimal counselling from the primary care doctors.

Care As Usual (to be continued)

All participants will be informed that their health care utilization, including their visits and use of medications will be recorded using the electronic patient record systems.

结局指标

主要结局

Reduction of self-reported depressive symptoms

时间窗: Assessments with the outcome measures will take place at baseline, two, five months (3 months after intervention) and 1 year.

次要结局

  • Incidence of DSM-IV major depression(1 year)
  • Improvement in quality of life(measured at baseline, two, five months (3 months after intervention) and 1 year.)
  • Utilization of health services including visits to primary care doctors(measured at baseline, two, five months (3 months after intervention) and 1 year.)
  • activity change and circumstantial change(measured at baseline, two, five months (3 months after intervention) and 1 year.)
  • patients to rate their impairment in 3 life domains including work, social and family/home management(measured at baseline, two, five months (3 months after intervention) and 1 year.)
  • Anxiety symptoms(measured at baseline, two, five months (3 months after intervention) and 1 year)
  • Satisfaction with delivered care(measured at baseline, two, five months (3 months after intervention) and 1 year)
  • Quality-adjusted life years(measured at baseline, two, five months (3 months after intervention) and 1 year)

研究者

发起方
HMRF

研究点 (1)

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