Clinical trial NCT04780178: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With ADRD
Official title: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias (TACTICs): A Pilot Randomized Controlled Trial (RRF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Caregiver Burden
Keywords: Dementia
Alzheimer's disease
Caregiving
Caregiver
Anxiety
Telehealth
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Cleveland State University
First posted: 2021-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to receive either the TACTICs telephone therapy or the minimally enhanced usual care packet of information.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Secondary outcomes:
Other outcomes:
measure: Patient Health Questionnaire-8
timeFrame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
measure: Zarit Burden Interview
timeFrame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
measure: Experience of Suffering Scale
timeFrame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
measure: Multidimensional Psychological Flexibility Inventory
timeFrame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
measure: Satisfaction with Life Scale
timeFrame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
measure: Quality of Life in Alzheimer's Disease
timeFrame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
measure: Intervention Acceptability
timeFrame: Post-intervention (7-9 weeks post-baseline)
measure: Health Care and Resource Utilization
timeFrame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
measure: Inventory of Complicated Grief
timeFrame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month ICG will (only) be measured in participants who have their loved one with dementia die during the study and agree to this survey
measure: Anticipatory grief
timeFrame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month AGS will (only) be measured in participants who have their loved one with dementia die during the study and agree to this survey
Locations:
city: Indianapolis
country: United States
facility: IUH
state: Indiana
Study officials:
affiliation: Indiana University
name: Nicole R Fowler, PhD
role: PRINCIPAL_INVESTIGATOR
References: