An Eight-week Program for Family Caregivers of People With Dementia Involving Coach-guided Videoconferencing Sessions With the Use of a Web App Based on Acceptance and Commitment Therapy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change from baseline to immediately after the 8-week intervention on the Patient Health Questionnaire-9
研究概览
简要总结
The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews.
详细描述
The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews. Participants' characteristics will be summarized using descriptive statistics. Either the Wilcoxon signed-rank test (a non-parametric test) or the paired sample t-test (a parametric test) will be performed to test the exploratory hypothesis that participants' scores for the outcome measures would significantly improve at posttest compared to pretest. Because of the exploratory nature of the study, no adjustment of p values will be conducted for multiple statistical comparisons of the outcome measures. Statistical significance will be set at p <.05, and the effect sizes derived from this pilot study will form a basis for determining a sample size with sufficient statistical power required for a subsequent clinical trial. Caregivers' experiences in the app use and perspectives on the developed app will be explored using individual Zoom interviews. Interpretative phenomenological analysis will be used to analyze the interview data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •having at least mild depression as measured by the Patient Health Questionnaire (PHQ)-9
- •having a web-enabled device (e.g., a smartphone, a tablet, or a laptop/desktop) with the internet access at home
排除标准
- •having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that might impede study participation
- •receiving a psychological therapy at the time of recruitment
- •having a prior experience in acceptance and commitment therapy
- •having psychiatric hospitalizations in the previous two years
- •considering or planning to place relatives with dementia in a nursing home within 3 months
- •recent frequent hospitalizations of their relatives with dementia that might contribute to study dropout
结局指标
主要结局
Change from baseline to immediately after the 8-week intervention on the Patient Health Questionnaire-9
时间窗: Change from baseline to immediately after the 8-week intervention
The Patient Health Questionnaire-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.
次要结局
- Change from baseline to immediately after the 8-week intervention on the Zarit Burden Interview(Change from baseline to immediately after the 8-week intervention)
- Change from baseline to immediately after the 8-week intervention on the Marwit-Meuser Caregiver Grief Inventory Brief-Form(Change from baseline to immediately after the 8-week intervention)
- Change from baseline to immediately after the 8-week intervention on the World Health Organization Quality of Life - Psychological health component(Change from baseline to immediately after the 8-week intervention)
- Change from baseline to immediately after the 8-week intervention on the Five Facet Mindfulness Questionnaire(Change from baseline to immediately after the 8-week intervention)
- Change from baseline to immediately after the 8-week intervention on the Generalized Anxiety Disorder-7(Change from baseline to immediately after the 8-week intervention)
- Change from baseline to immediately after the 8-week intervention on the Perceived Stress Scale(Change from baseline to immediately after the 8-week intervention)
- Change from baseline to immediately after the 8-week intervention on the Caregiver Guilt Questionnaire(Change from baseline to immediately after the 8-week intervention)
- Change from baseline to immediately after the 8-week intervention on the Action and Acceptance Questionnaire-II(Change from baseline to immediately after the 8-week intervention)
- Change from baseline to immediately after the 8-week intervention on the Self-Compassion Scale-Short Form(Change from baseline to immediately after the 8-week intervention)
- Change from baseline to immediately after the 8-week intervention on the Cognitive Fusion Questionnaire(Change from baseline to immediately after the 8-week intervention)
- Change from baseline to immediately after the 8-week intervention on the Engaged Living Scale(Change from baseline to immediately after the 8-week intervention)
研究者
Areum Han
Assistant professor
University of Alabama at Birmingham