Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias. A Single Arm Pilot
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Anxiety symptoms measured by the Generalized Anxiety Disorder Scale (GAD-7)
Study Overview
Brief Summary
Caregivers of adults with dementia report higher stress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases.
Detailed Description
Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. The Investigators are trying to determine proof of concept that suggests that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. This study will recruit N=20 dementia caregivers to receive 6 weekly 1-hour telephone-based ACT sessions
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 related dementia (DARD)
- •Intends to continue caregiving form ADRD patient for at least 12 months or greater
- •Clinically elevated anxiety score (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
Arms & Interventions
Experimental TACTICs
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of adults with dementia (TACICS. Participants will receive a manualized acceptance and commitment therapy intervention delivered via phone in 6 weekly 1 hour sessions by a trained interventionalist
Intervention: ACT Acceptance and Commitment Therapy (Behavioral)
Outcomes
Primary Outcomes
Anxiety symptoms measured by the Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: through study completion, an average of 6 months
Anxiety will be measured using the GAD-7 which contains 7 items with total scores ranging from 0 to 21. Scores of 5, 10 and 15 are cut off scores 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
Secondary Outcomes
- Caregivers grief during active caregiving will be measured with the Anticipatory Grief Scale (AGS)(through study completion, an average of 6 months)
- Depressive symptoms measured by the Patient Health Questionnarie-9 (PHQ-9)(through study completion, an average of 6 months)
- Caregivers psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II)(through study completion, an average of 6 months)
- Caregiver burden measured by the Zarit Burden Interview (ZBI)(through study completion, an average of 6 months)
- Physical, emotional and existential suffering to caregivers measured by the Experience of Suffering Scale (ESS)(through study completion, an average of 6 months)
- Different strategies that caregivers use to cope measured with the Brief COPE(through study completion, an average of 6 months)
- Overall quality of life will be measured with the NIH PROMIS Global Health measure(through study completion, an average of 6 months)
Investigators
Nicole R. Fowler, PhD
Associate Professor of Medicine
Indiana University