Effects of a Coach-Guided Online Acceptance and Commitment Therapy (ACT) Intervention on Stroke Survivors: A Pilot Randomized Controlled Trial
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 intervention and 2-month follow-up on the Patient Health Questionnaire-9
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 stroke survivors compared to the care-as-usual control group. A total of 24 stroke survivors who meet the inclusion criteria will be recruited and randomized to either the intervention group or the control group. Exploratory hypotheses are that the ACT group will show improvements in mental health outcomes (e.g., depressive symptoms, anxiety, and stress), and ACT processes (e.g., psychological flexibility/acceptance) at posttest and 2-month follow-up, compared to the care-as-usual control group. Also, the project will evaluate the feasibility of recruitment, adherence, and retention of participants and explore participants' experiences in the ACT intervention through semi-structured interviews at posttest.
详细描述
This pilot randomized controlled trial aims to assess effects of a coach-guided individual online acceptance and commitment therapy (ACT) intervention on distressed stroke survivors compared to the care-as-usual control group. A total of 24 stroke survivors who meet the inclusion criteria will be recruited and randomized to either the intervention group or the control group. The intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 6 weeks through Zoom videoconferencing. Also, a one-time 1-hour booster session will be provided at 1-month follow-up to facilitate the maintenance of treatment effects. All ACT sessions will be delivered by our ACT coach, a licensed professional counselor (LPC) with substantial clinical experiences and expertise in ACT. Participants assigned to the control group will receive care as usual during the study period. Outcomes regarding mental health and ACT processes will be collected at three time points (i.e., pretest, posttest, and 2-month follow-up) and compared between groups over time. Mental health outcomes and ACT processes will be measured using self-reported questionnaires. A 30-minute individual interview also will be conducted for participants in the intervention group through Zoom videoconferencing to explore participants' experiences in the ACT intervention. The participant demographic information form will be asked to complete at pretest only, asking participants' information such as age, gender, ethnicity/race, level of education, marital status, employment status, and time since stroke.
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 (aged 18 or above) with a confirmed diagnosis of stroke
- •having at least mild symptoms of psychological distress measured by the Depression, Anxiety and Stress Scale
- •having a computer or a smartphone with internet access at home
- •being able to provide informed consent by understanding the nature of study participation
排除标准
- •living in a nursing home at time of consent
- •a diagnosis of severe cognitive impairment (e.g., dementia)
- •inability to understand spoken and/or written English
- •having severe communication difficulties (e.g., aphasia and dysarthria) that can impede study participation
- •having a life-threatening illness (e.g. advanced cancer or advanced heart failure) that would make survival for 6 months unlikely
- •having a diagnosis of other central nervous system disorders other than stroke or a severe mental illness (e.g., psychosis)
- •currently receiving a psychological therapy or participating in another study that may affect mental health
- •having a prior experience in ACT
- •having psychiatric hospitalizations or diagnoses of mental illness in the previous two years
- •taking antipsychotic medication at the time of recruitment.
结局指标
主要结局
Change from baseline to immediately after the intervention and 2-month follow-up on the Patient Health Questionnaire-9
时间窗: Change from baseline to immediately after the intervention and 2-month follow-up
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.
Change from baseline to immediately after the intervention and 2-month follow-up on the Generalized Anxiety Disorder-7
时间窗: Change from baseline to immediately after the intervention and 2-month follow-up
The Generalized Anxiety Disorder-7 is a 7-item questionnaire assessing anxiety on a scale of 0 to 3. Scores range from 0 to 21. Higher scores indicate greater anxiety.
Change from baseline to immediately after the intervention and 2-month follow-up on the Perceived Stress Scale
时间窗: Change from baseline to immediately after the intervention and 2-month follow-up
The Perceived Stress Scale is a 10-item questionnaire assessing stress on a scale of 0 to 4. Scores range from 0 to 40. Higher scores indicate greater stress.
次要结局
- Change from baseline to immediately after the intervention and 2-month follow-up on the World Health Organization Quality of Life - Psychological health component(Change from baseline to immediately after the intervention and 2-month follow-up)
- Change from baseline to immediately after the intervention and 2-month follow-up on the Self-Compassion Scale- Short Form(Change from baseline to immediately after the intervention and 2-month follow-up)
- Change from baseline to immediately after the intervention and 2-month follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) - Meaning and Purpose Short Form(Change from baseline to immediately after the intervention and 2-month follow-up)
- Change from baseline to immediately after the intervention and 2-month follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Emotions - Short Form(Change from baseline to immediately after the intervention and 2-month follow-up)
- Change from baseline to immediately after the intervention and 2-month follow-up on the Action and Acceptance Questionnaire-II(Change from baseline to immediately after the intervention and 2-month follow-up)
- Change from baseline to immediately after the intervention and 2-month follow-up on the Cognitive Fusion Questionnaire(Change from baseline to immediately after the intervention and 2-month follow-up)
- Change from baseline to immediately after the intervention and 2-month follow-up on the Engaged Living Scale(Change from baseline to immediately after the intervention and 2-month follow-up)
研究者
Areum Han
Assistant professor
University of Alabama at Birmingham