Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With ADRD

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Caregiver Burden

Intervention / Treatment
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* Behavioral: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to receive either the TACTICs telephone therapy or the minimally enhanced usual care packet of information.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACTICs<br>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. | Behavioral: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias<br>* A telephone-based acceptance and commitment therapy for caregivers<br>* Other names: TACTICs;|
| No Intervention: Minimally Enhanced Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder Scale (GAD-7) | 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. | Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Dementia, Alzheimer's disease, Caregiving, Caregiver, Telehealth