Clinical trial NCT04634396: Possible Therapy by Phone for Caregivers
Official title: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias. A Single Arm Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Anxiety Disorders and Symptoms
Caregiver Burnout
Keywords: Alzheimer's disease
Dementia
Caregiving
Caregiver
Anxiety
Acceptance and commitment therapy
Telehealth
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Regenstrief Institute, Inc.
First posted: 2020-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm proof of concept study
Primary purpose: SUPPORTIVE_CARE

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

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 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

Primary outcomes:
measure: Anxiety symptoms measured by the Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Depressive symptoms measured by the Patient Health Questionnarie-9 (PHQ-9)
timeFrame: through study completion, an average of 6 months
measure: Caregiver burden measured by the Zarit Burden Interview (ZBI)
timeFrame: through study completion, an average of 6 months
measure: Physical, emotional and existential suffering to caregivers measured by the Experience of Suffering Scale (ESS)
timeFrame: through study completion, an average of 6 months
measure: Different strategies that caregivers use to cope measured with the Brief COPE
timeFrame: through study completion, an average of 6 months
measure: Caregivers psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: through study completion, an average of 6 months
measure: Overall quality of life will be measured with the NIH PROMIS Global Health measure
timeFrame: through study completion, an average of 6 months
measure: Caregivers grief during active caregiving will be measured with the Anticipatory Grief Scale (AGS)
timeFrame: through study completion, an average of 6 months
Other outcomes:
measure: The feasibility of the TACTICs Intervention will be measured by accrual rate, attendance of sessions, and the retention in the study
timeFrame: baseline and through study completion, an average of 6 months.
measure: Caregivers acceptability of the TACTICs intervention
timeFrame: through study completion, an average of 6 months
Locations:
city: Indianapolis
country: United States
facility: Regenstrief Institute, Inc.
state: Indiana
Study officials:
affiliation: Indiana University
name: Shelley A. Johns, PhD
role: PRINCIPAL_INVESTIGATOR
References: