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临床试验/NCT02785211
NCT02785211已完成不适用

A Modified Behavioral Activation Treatment for Geriatric Depressive Symptoms in Left-behind Elderly in Rural China

The Third Xiangya Hospital of Central South University0 个研究点目标入组 80 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
depression assessed with the Geriatric Depression Scale

研究概览

简要总结

Background: It is essential to understand how to prevent and treat the epidemic of depression. Several studies have reported the prevalence of depressive symptoms in the urban population in China, but there is a lack of information regarding intervention for depression in rural left behind old elderly people.

Objective: To evaluate the effectiveness of a Modified Behavioral Activation Treatment (MBAT) Intervention on reducing depressive symptoms in rural left behind elderly people.

Methods: 80 rural left behind elderly people who had a Geriatric Depression Scale(GDS) score between 11 and 25 will be recruited and randomly assigned to the intervention (n=40) and control group(n=40). The intervention group will be received both MBAT and treatment-as-usual for 8 weeks while the control group received treatment-as-usual. Both groups will be assessed with the GDS, Beck Anxiety Inventory (BAI), and Oxford Happiness Questionnaire (OHQ) at baseline, immediately post-intervention, and at 3 months post-intervention.

Significance: This is the first time BA psychotherapy will be used in China.The current study will develop an intention model based on the traditional BA and CBT. The recurrence and seriousness of depression symptoms may be reduced by the intervention program. We hope that MBAT in clients will provide a direction for the management of mental health in rural left-behind elders..

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
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 65 years of age;
  • Only one participant from each family;
  • Left-behind for longer than 6 months;
  • GDS score between 11 and 25.

排除标准

  • Psychiatric and medical comorbidities that are potentially life threatening or expected to severely limit client participation or adherence;
  • Those who are currently seeing a cognitive behavioral therapist, psychotherapist or counselor;
  • People unable to understand and fill out the questionnaires.

研究组 & 干预措施

Behavioral Activation Treatment

Experimental

The modified model will be provided weekly to four groups for intervention, each group including about 10 participants with 1 facilitator for a period of 8 weeks after the baseline survey and general introduction. Each of the 8-week sessions will last for 2 hours. Groups 1 to 4 will have sessions on Mondays, Tuesdays, Wednesdays, and Thursdays respectively; four groups will meet on the same day of the week for all 8 weeks. The scheduling and timing of intervention provide consistency of scheduling for participants.

干预措施: Behavioral Activation Treatment (Behavioral)

control group

Placebo Comparator

For the control group, participants will receive regular physical examinations and education by village doctors weekly during the 8 week intervention.The weekly visits for every old people whose age above 65 by country doctors are not arranged by our study, it is the country doctors" routine work by government health policy. This study was permitted by the local community health center, the director with specific responsibility will inform all country doctors to support our study.

干预措施: Behavioral Activation Treatment (Behavioral)

结局指标

主要结局

depression assessed with the Geriatric Depression Scale

时间窗: After 8 weeks MBAT, the GDS scores in the intervention group decreased significantly compared to those in the control group

Depression symptoms will be measured using the validated Chinese version of the Geriatric Depression Scale. The scale consists of 30 questions, used to screen for depressive symptoms in community-dwelling elderly to evaluate the effect of reminiscence on depressive symptoms.Questions ask elderly participants to describe feelings over the past week and responses are "Yes" or "No". Its ease of use makes it suitable for community studies. Scores from 0 to 10 are regarded as normal, 11-20 as mild depression, 21-25 as moderate depression, and 26-30 as severe depression. The internal consistency reliability of the scale was 0.89 and test-retest reliability was 0.85; criterion related validity was 0.95, and parallel validity using the center for Epidemiologic Studies Depression Scale (CES-D) was 0.96 in Chinese participants (Wang,1999).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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