Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias (TACTICs): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Baseline Anxiety via Generalized Anxiety Disorder scale-7 (GAD-7)
研究概览
简要总结
Caregivers of adults with dementia report higher distress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases. Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. Results from our recent proof-of-concept study suggest that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. In this study, we will randomize N=60 dementia caregivers in equal numbers to receive either 6 weekly 1-hour telephone-based ACT sessions (TACTICs; experimental) or minimally-enhanced usual care (mEUC; control). We hypothesize that our TACTICs intervention will be feasible and acceptable in this population and will have a greater impact on reducing anxiety and secondary outcomes from baseline to post-intervention, and 3 and 6 months later.
详细描述
The objective of this pilot randomized controlled trial is to assess feasibility, acceptability, and preliminary effects of Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs) of adults with Alzheimer's disease or related dementias. Using a 2-arm randomized design, we will examine the effects of TACTICs compared to a minimally enhanced usual care group (mEUC) in N=60 dementia caregivers. Primary dementia caregivers with clinically-significant anxiety will be randomized in equal numbers to receive either TACTICs or mEUC. The specific aims are to: (1) Evaluate the feasibility and acceptability of TACTICs. Feasibility will be assessed using caregiver accrual, retention, and TACTICs session attendance rates. Acceptability will be assessed using a participant-reported satisfaction item administered upon intervention completion. (2) Measure the changes in caregiver anxiety and depressive symptoms, caregiver burden, wellbeing, and psychological flexibility at post-intervention (T2) and 3 months (T3) and 6 months (T4) post-intervention compared to baseline. Caregivers will be recruited from a variety of sources, including the Indiana Alzheimer's Disease Center (IADC), Aging Brain Care program at Eskenazi Health, and Indiana University Health geriatric psychiatry and neurology practices. Study staff will contact potentially-eligible caregivers to assess interest and verify eligibility. After providing informed consent and enrolling in the trial, interested and eligible caregivers will complete baseline measures and be randomly assigned in equal numbers to either the TACTICs intervention (n=30) or to mEUC (n=30) using a block randomization scheme. Randomization will be performed in REDCap using a SAS procedure. All study personnel will be blind to allocation sequence. The unblinded research coordinator will be responsible for randomizing participants in REDCap. The PI, Co-Investigators, and research assistants (i.e., recruiters and outcome assessors) will be blind to intervention assignment to reduce the risk of outcome expectancy bias and to enhance the rigor of the trial.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Principal Investigator and Outcomes Assessors are blinded to randomization sequence and randomization assignments for the duration of the study.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years or older
- •Able to communicate in English
- •Able to provide informed consent
- •Listed as primary caregiver in the chart of a patient with Alzheimer's disease or a related dementia (ADRD)
- •Self-identifies as ADRD patient's primary caregiver
- •Intends to continue caregiving for ADRD patient for ≥12 months
- •Clinically-elevated anxiety (score of 10 or higher on GAD-7)
排除标准
- •Non-family member of the ADRD patient
- •Has ADRD or other serious mental illness diagnosis such as bipolar or schizophrenia as determined by ICD-10 code
结局指标
主要结局
Change in Baseline Anxiety via Generalized Anxiety Disorder scale-7 (GAD-7)
时间窗: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Changes in anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7), which contains 7 items with total scores ranging from 0 to 21. Scores of 5, 10, and 15 are cut-offs for mild, moderate, and severe anxiety, respectively. An add-on item assessing the patient's global impression of symptom-related impairment helps researchers understand the extent to which anxiety interferes in daily life. The GAD-7 has factorial validity for the diagnosis of general anxiety disorder and is sensitive to change.
次要结局
- Change in Baseline Coping via Brief COPE(baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention)
- Change in Baseline Anticipatory Grief via Anticipatory Grief Scale (AGS)(baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention)
- Change in Baseline Depressive Symptoms via Patient Health Questionnaire-9 (PHQ-9)(baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention)
- Change in Baseline Wellbeing via Experience of Suffering Scale (ESS)(baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention)
- Change in Baseline Psychological Flexibility via Acceptance and Action Questionnaire-II (AAQ-II)(baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention)
- Change in Baseline Caregiver Burden via Zarit Burden Interview (ZBI)(baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention)
- Change in Baseline Quality of Life via PROMIS Global Health measure(baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention)
研究者
Shelley Johns
Assistant Professor of Medicine
Indiana University