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

NCT04780178 | Completed

• 1 other identifier: 10320
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Dementia; Alzheimer's disease; Caregiving; Caregiver; Anxiety; Telehealth

Outcome Measures

Primary Outcomes (1)

• Generalized Anxiety Disorder Scale (GAD-7)

  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.

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

Other Outcomes (10)

• Patient Health Questionnaire-8

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

• Zarit Burden Interview

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

• Experience of Suffering Scale

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

Study Arms (2)

TACTICs

EXPERIMENTAL

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.

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

Minimally Enhanced Usual Care

NO INTERVENTION

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.

Interventions

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

A telephone-based acceptance and commitment therapy for caregivers

Also known as: TACTICs

TACTICs

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years or older
• Able to communicate in English
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Cleveland State University: collaborator

Study Sites (1)

IUH

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Caregiver Burden; Dementia; Alzheimer Disease

Interventions

Amyloid beta-Protein Precursor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory

Study Officials

• Nicole R Fowler, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to participant group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Participants will be randomly assigned to receive either the TACTICs telephone therapy or the minimally enhanced usual care packet of information.

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 3, 2021
• Study Start: April 1, 2021
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)