Reducing Depression in Dementia Caregivers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)
研究概览
简要总结
The purpose of this study was to develop and examine the initial impact of a distance-based intervention for female family dementia caregivers. As stated in the original proposal, the primary hypothesis of the study was that family caregivers who participated in the Video Intervention would show greater reduction in psychological distress (i.e., on measures of depression and emotional distress following problematic patient behaviors) compared to those in the Basic Education condition, and that this effect would be maintained over time (3 and 6 months post-tx).
详细描述
Family caregivers of individuals with dementia commonly report depressive symptoms, along with other forms of emotional distress. This study compared the effectiveness of two home-based interventions to reduce levels of depressed, anxious, and other negative moods in women living with a family member with dementia. Eligible caregivers were randomly assigned to participate in either a video/workbook/telephone coaching intervention, or to a basic education condition consisting of a workbook and supportive telephone calls. Participants were evaluated for psychosocial distress after treatment, and at 3- and 6-months following the end of intervention.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Caregiver and dementia pt live in the same home
- •Resident of following states: Il,IN, IO, KS, MI, MN, MO, NB,WI
排除标准
- •Insulin dependent diabetes
- •Thyroid disease
研究组 & 干预措施
Behavioral Skills Training
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
干预措施: Behavioral Skills Training: Experimental (Behavioral)
Basic Education
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
干预措施: Basic Education (Behavioral)
结局指标
主要结局
Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)
时间窗: Post-intervention, assessed 4-14 days after final intervention session.
21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.
Beck Depression Inventory II (Beck, Steer & Brown, 1996)
时间窗: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.
次要结局
- Negative Affect Schedule (Watson, Clark & Tellegen, 1988)(Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention)
- Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)(Post-intervention, assessed 4-14 days after final intervention session.)