跳至主要内容
临床试验/NCT04780178
NCT04780178已完成不适用

Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias (TACTICs): A Pilot Randomized Controlled Trial (RRF)

Indiana University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
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

研究组 & 干预措施

TACTICs

Experimental

Our ACT intervention will include 6 weekly 1-hour telephone sessions and 1 booster session offered 1 month after session 6 designed to increase psychological flexibility through practice of one or more of the six skills in each session. Although these are ideally spaced 1 week apart, participants will have up to 12 weeks to complete the 6 sessions. Each session will include guided mindfulness practice that encourages non-judgmental awareness of the present moment to increase psychological flexibility; brief (10-minute) study-provided audio recordings will enable participants to practice mindfulness at home. Caregivers will also identify deeply-held values to serve as a guide when choosing how to spend limited time or energy and will set values-based action goals each week. A booster session will be provided one month after session 6 to reinforce skills learned.

干预措施: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias (Behavioral)

Minimally Enhanced Usual Care

No Intervention

All caregivers randomized to the mEUC group will receive a mailed packet containing 1) a letter from the Co-PIs thanking them for participating, 2) printed selections from of the NIH Alzheimer's caregiving website (https://www.nia.nih.gov/health/alzheimers/caregiving), and 3) a listing of Alzheimer's Association sponsored support groups closest to the caregiver's home address. Caregivers will also receive a brief phone call from the research coordinator to verify receipt of the packet. Since this is a usual care group with a minimally-enhanced component, it will be up to the mEUC participants to decide whether or not to engage with these intervention materials.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicole R. Fowler, PhD

Associate Professor of Medicine

Indiana University

研究点 (1)

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