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

NCT04338750 | Completed DMC

• 1 other identifier: 2002468698
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Alzheimer's disease; Dementia; Caregiving; Caregiver; Anxiety; Acceptance and commitment therapy; Telehealth

Outcome Measures

Primary Outcomes (1)

• Change in Baseline Anxiety via Generalized Anxiety Disorder scale-7 (GAD-7)

  Changes in anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7), which 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 months post-intervention, 6 months post-intervention

Secondary Outcomes (7)

• Change in Baseline Depressive Symptoms via Patient Health Questionnaire-9 (PHQ-9)

  baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention

• Change in Baseline Caregiver Burden via Zarit Burden Interview (ZBI)

  baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention

• Change in Baseline Wellbeing via Experience of Suffering Scale (ESS)

  baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention

• Change in Baseline Coping via Brief COPE

  baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention

• Change in Baseline Psychological Flexibility via Acceptance and Action Questionnaire-II (AAQ-II)

  baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention

Other Outcomes (5)

• Intervention feasibility: accrual rate

  baseline

• Intervention feasibility: attendance rate

  post-intervention

• Intervention feasibility: retention rate

  6 months post-intervention

Study Arms (2)

Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs)

EXPERIMENTAL

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.

Behavioral: Telephone Acceptance and Commitment Therapy Intervention for Caregivers

minimally-Enhanced Usual Care (mEUC)

ACTIVE COMPARATOR

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.

Behavioral: minimally-Enhanced Usual Care

Interventions

Telephone Acceptance and Commitment Therapy Intervention for Caregivers 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.

Also known as: TACTICs

Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs)

minimally-Enhanced Usual Care 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.

Also known as: mEUC

minimally-Enhanced Usual Care (mEUC)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Indiana Clinical and Translational Sciences Institute: collaborator
• Regenstrief Institute, Inc.: collaborator

Study Sites (1)

Regenstrief Institute, Inc.

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder; Caregiver Burden; Alzheimer Disease; Dementia

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Shelley A. Johns, PsyD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Principal Investigator and Outcomes Assessors are blinded to randomization sequence and randomization assignments for the duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Caregivers of adults with Alzheimer's disease or related dementias (N = 60) will be randomly assigned in equal numbers to Acceptance and Commitment Therapy delivered by telephone (TACTICs) or minimally-enhanced usual care (mEUC) using a block randomization scheme.

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 8, 2020
• Study Start: March 24, 2020
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. Data will be available for at least 6 years.
• Access Criteria: The data set and supporting information will be made available to qualified investigators to allow replication of analyses or secondary data analyses. The PI will review requests for data access. The investigators will be required to sign a data use agreement and obtain IRB approval before receiving the data set. The mechanism for data sharing will be reviewed by the IRB.

Locations

US (1)