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

NCT ID: NCT04338750

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-24
• Study Completion Date: 2021-04-09

Brief 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.

Detailed Description

The objective of this pilot randomized controlled trial is to assess feasibility, acceptability, and preliminary effects of Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs) of adults with Alzheimer's disease or related dementias. Using a 2-arm randomized design, we will examine the effects of TACTICs compared to a minimally enhanced usual care group (mEUC) in N=60 dementia caregivers. Primary dementia caregivers with clinically-significant anxiety will be randomized in equal numbers to receive either TACTICs or mEUC. The specific aims are to: (1) Evaluate the feasibility and acceptability of TACTICs. Feasibility will be assessed using caregiver accrual, retention, and TACTICs session attendance rates. Acceptability will be assessed using a participant-reported satisfaction item administered upon intervention completion. (2) Measure the changes in caregiver anxiety and depressive symptoms, caregiver burden, wellbeing, and psychological flexibility at post-intervention (T2) and 3 months (T3) and 6 months (T4) post-intervention compared to baseline. Caregivers will be recruited from a variety of sources, including the Indiana Alzheimer's Disease Center (IADC), Aging Brain Care program at Eskenazi Health, and Indiana University Health geriatric psychiatry and neurology practices. Study staff will contact potentially-eligible caregivers to assess interest and verify eligibility. After providing informed consent and enrolling in the trial, interested and eligible caregivers will complete baseline measures and be randomly assigned in equal numbers to either the TACTICs intervention (n=30) or to mEUC (n=30) using a block randomization scheme. Randomization will be performed in REDCap using a SAS procedure. All study personnel will be blind to allocation sequence. The unblinded research coordinator will be responsible for randomizing participants in REDCap. The PI, Co-Investigators, and research assistants (i.e., recruiters and outcome assessors) will be blind to intervention assignment to reduce the risk of outcome expectancy bias and to enhance the rigor of the trial.

Conditions

Anxiety; Anxiety Generalized; Anxiety Disorders and Symptoms; Caregiver Burnout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs)

Participants in the ACT arm will learn new and more adaptive ways to respond to challenges, including anxiety and the irreversibility of dementia and its behavioral manifestations.

Group Type: EXPERIMENTAL

Telephone Acceptance and Commitment Therapy Intervention for Caregivers

Intervention Type: BEHAVIORAL

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.

minimally-Enhanced Usual Care (mEUC)

Participants randomized to mEUC will receive educational, science-based reading and resources, including a listing of Alzheimer's Association sponsored support groups closest to their home address.

Group Type: ACTIVE_COMPARATOR

minimally-Enhanced Usual Care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

TACTICs; mEUC

Eligibility Criteria

Inclusion Criteria

• 21 years or older
• Able to communicate in English
• Able to provide informed consent
• Listed as primary caregiver in the chart of a patient with Alzheimer's disease or a related dementia (ADRD)
• Self-identifies as ADRD patient's primary caregiver
• Intends to continue caregiving for ADRD patient for ≥12 months
• Clinically-elevated anxiety (score of 10 or higher on GAD-7)

Exclusion Criteria

• Non-family member of the ADRD patient
• Has ADRD or other serious mental illness diagnosis such as bipolar or schizophrenia as determined by ICD-10 code

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

Sponsors

Indiana Clinical and Translational Sciences Institute

OTHER

Sponsor Role: collaborator

Regenstrief Institute, Inc.

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Shelley Johns

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shelley A. Johns, PsyD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Regenstrief Institute, Inc.

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

2002468698

Identifier Type: -

Identifier Source: org_study_id