A Guided Eight-week Online Acceptance and Commitment Therapy (ACT) Intervention for Distressed Family Caregivers of People With Dementia: A Mixed-methods Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change from baseline to immediately after the intervention and 1 month follow-up on the Depression, Anxiety and Stress Scale
研究概览
简要总结
The pilot randomized controlled trial aims to assess effects of a guided online acceptance and commitment therapy (ACT) intervention on distressed family caregivers of people with dementia (PwD) compared to the control group. A total of 24 family caregivers of PwD who meet the inclusion criteria will be recruited and randomized to either the intervention or control group. Exploratory hypotheses are that the ACT group will show decreases in caregivers' psychological distress and burden and improvements in QoL and engagement in meaningful activities at posttest and 1-month follow-up, compared to the control group. Also, the project will evaluate the feasibility of recruitment, adherence, and retention of caregivers and explore caregivers' experiences in the ACT intervention through semi-structured interviews at posttest. As part of the pretest, we will also explore caregivers' perceived impacts of COVID-19 on daily lives.
详细描述
The pilot randomized controlled trial aims to assess effects of a guided online acceptance and commitment therapy (ACT) intervention on distressed family caregivers of people with dementia (PwD) compared to the control group. A total of 24 family caregivers of PwD who meet the inclusion criteria will be recruited and randomized to either the intervention or control group. Caregivers assigned to the intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 8 weeks through Zoom videoconferencing with supplemental psychoeducation materials provided. Caregivers assigned to the control group will receive care as usual with psychoeducation materials provided. Outcomes regarding caregivers' mental health will be collected at three time points (i.e., pretest, posttest, and 1-month follow-up) and compared between groups over time. Exploratory hypotheses are that the ACT group will show decreases in caregivers' psychological distress and burden and improvements in QoL and engagement in meaningful activities at posttest and 1-month follow-up, compared to the control group. Also, the project will evaluate the feasibility of recruitment, adherence, and retention of caregivers and explore caregivers' experiences in the ACT intervention through semi-structured interviews at posttest. As part of the pretest, we will also explore caregivers' perceived impacts of COVID-19 on daily lives.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •community-dwelling adults (age 18 or over) who are currently taking the primary responsibility for the care of a relative with dementia living in the community
- •devoting at least four hours daily to the care of the relative with dementia
- •having at least mild symptoms of psychological distress as measured by the Depression, Anxiety and Stress Scale (DASS-21; Antony et al., 1988)
- •having a computer or a smartphone with the internet access at home and
- •being able to provide informed consent.
排除标准
- •having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that impede study participation
- •currently receiving a psychological therapy
- •having a prior experience in ACT
- •having psychiatric hospitalizations or diagnoses of mental illness in the previous two years
- •taking antipsychotic or anticonvulsant medication at the time of recruitment
- •considering or planning to place family members of PwD in a nursing home within four months or
- •having the possibility of study dropouts due to other medical conditions of family members with dementia (e.g., conditions that may impede study participation due to frequent hospitalization or death)
结局指标
主要结局
Change from baseline to immediately after the intervention and 1 month follow-up on the Depression, Anxiety and Stress Scale
时间窗: Change from baseline to immediately after the intervention and 1 month follow-up
Depression, Anxiety and Stress Scale - 21 is a 21-item questionnaire assessing depressive symptoms, anxiety, and stress over the past 7 days on a scale of 0 to 3. Scores on the individual subscales range from 0 to 21. Higher scores indicate greater symptomatology in each subscale of depressive symptoms (7 items), anxiety (7 items), and stress (7 items).
Change from baseline to immediately after the intervention and 1 month follow-up on the Zarit Burden Interview
时间窗: Change from baseline to immediately after the intervention and 1 month follow-up
Zarit Burden Interview is a 12-item self-report questionnaire assessing caregiver burden on a scale of 0 to 4. Higher scores indicate higher levels of burden. The total scores range from 0 to 48, and scores of 17 or greater indicate severe/high burden.
次要结局
- Change from baseline to immediately after the intervention and 1 month follow-up on the Cognitive Fusion Questionnaire(Change from baseline to immediately after the intervention and 1 month follow-up)
- Change from baseline to immediately after the intervention and 1 month follow-up on the Meuser Caregiver Grief Inventory(Change from baseline to immediately after the intervention and 1 month follow-up)
- Change from baseline to immediately after the intervention and 1 month follow-up on the Self-Compassion Scale- Short Form(Change from baseline to immediately after the intervention and 1 month follow-up)
- Change from baseline to immediately after the intervention and 1 month follow-up on the Engagement in Meaningful Activities Survey(Change from baseline to immediately after the intervention and 1 month follow-up)
- Change from baseline to immediately after the intervention and 1 month follow-up on the Caregiver Guilt Questionnaire(Change from baseline to immediately after the intervention and 1 month follow-up)
- Change from baseline to immediately after the intervention and 1 month follow-up on the World Health Organization Quality of Life-BREF - Psychological health component(Change from baseline to immediately after the intervention and 1 month follow-up)
- Change from baseline to immediately after the intervention and 1 month follow-up on the Action and Acceptance Questionnaire-II(Change from baseline to immediately after the intervention and 1 month follow-up)
研究者
Areum Han
Assistant professor
University of Alabama at Birmingham