Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias (TACTICs): A Pilot Randomized Controlled Trial (RRF)
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
- Generalized Anxiety Disorder Scale (GAD-7)
研究概览
简要总结
The purpose of the study is to test if Acceptance and Commitment Therapy (ACT), a behavioral intervention designed to increase psychological flexibility in the face of challenges, reduces anxiety associated psychological distress in dementia caregivers compared to the control group who will receive self-help and educational materials. This version of ACT is delivered over the phone in six primary sessions and one booster session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to participant group assignment.
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Listed in ADRD patient's chart as primary caregiver or self-identifies as ADRD patient's primary caregiver
- •Intends to continue caregiving for ≥12 months
- •Clinically-significant anxiety (score ≥10 on GAD-7)
- •21 years or older
- •Able to communicate in English
- •Able to provide informed consent
排除标准
- •Caregiver is a non-family member
- •Care recipient is in an assisted living or nursing home (at baseline)
- •Has ADRD or other serious mental illness diagnosis such as schizophrenia as determined by ICD-10 code or self-report
- •Caregiver is enrolled in an existing ADRD collaborative program at Eskenazi Health, IU Health or the VA.
- •Caregiver is enrolled in another IU study that is testing a ADRD caregiver intervention
结局指标
主要结局
Generalized Anxiety Disorder Scale (GAD-7)
时间窗: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
The Generalized Anxiety Disorder Scale (GAD-7) 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
未报告次要终点
研究者
Nicole R. Fowler, PhD
Associate Professor of Medicine
Indiana University