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

Not Applicable

Completed

• Conditions: Caregiver Burden; Anxiety
• Interventions: Behavioral: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias

• Registration Number: NCT04780178
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-03
• Study Start: 2021-04-01
• Status Verified: 2022-08
• Primary Completion: 2022-08-08
• Study Completion: 2022-08-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACTICs	Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias	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.

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder Scale (GAD-7)	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.

Trial Locations

Locations (1)

IUH; 🇺🇸 Indianapolis, Indiana, United States