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

NCT ID: NCT04780178

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-08-08

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.

Conditions

Anxiety; Caregiver Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

TACTICs

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

A telephone-based acceptance and commitment therapy for caregivers

Minimally Enhanced Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

A telephone-based acceptance and commitment therapy for caregivers

Intervention Type: BEHAVIORAL

Other Intervention Names

TACTICs

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cleveland State University

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Nicole R. Fowler, PhD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicole R Fowler, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

IUH

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

10320

Identifier Type: -

Identifier Source: org_study_id