Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias (TACTICs): A Pilot Randomized Controlled Trial (RRF)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- Indiana University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Generalized Anxiety Disorder Scale (GAD-7)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Nicole R. Fowler, PhD
Associate Professor of Medicine
Indiana University
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
Outcomes
Primary Outcomes
Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
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.