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

NCT04338750 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-07-26

No results posted yet for this study

Summary

Caregivers of adults with dementia report higher distress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases. Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. Results from our recent proof-of-concept study suggest that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. In this study, we will randomize N=60 dementia caregivers in equal numbers to receive either 6 weekly 1-hour telephone-based ACT sessions (TACTICs; experimental) or minimally-enhanced usual care (mEUC; control). We hypothesize that our TACTICs intervention will be feasible and acceptable in this population and will have a greater impact on reducing anxiety and secondary outcomes from baseline to post-intervention, and 3 and 6 months later.

Conditions

  • Anxiety
  • Anxiety Generalized
  • Anxiety Disorders and Symptoms
  • Caregiver Burnout

Interventions

BEHAVIORAL

Telephone Acceptance and Commitment Therapy Intervention for Caregivers

Participants randomized to TACTICs will receive a manualized acceptance and commitment therapy intervention delivered via phone in 6 weekly 1-hour sessions by a trained Bachelor's-level interventionist. Participants in this intervention will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' caregiving experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to anxiety and caregiving challenges. Participants will receive handouts on session topics and a CD with guided mindfulness practices.

BEHAVIORAL

minimally-Enhanced Usual Care

Participants randomized to mEUC will receive a letter thanking them for participating in the trial along with the Alzheimer's Caregiving guide from the National Institute of Aging of the National Institutes of Health (https://www.nia.nih.gov/health/alzheimers/caregiving), coupled with a listing of the five Alzheimer's Association sponsored support groups closest to their home address.

Sponsors & Collaborators

  • Indiana Clinical and Translational Sciences Institute

    collaborator OTHER
  • Regenstrief Institute, Inc.

    collaborator OTHER
  • Indiana University

    lead OTHER

Principal Investigators

  • Shelley A. Johns, PsyD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-24
Primary Completion
2021-04-09
Completion
2021-04-09

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338750 on ClinicalTrials.gov