Clinical trial NCT04338750: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Dementia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Anxiety Generalized
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: Indiana Clinical and Translational Sciences Institute
name: Regenstrief Institute, Inc.
First posted: 2020-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Caregivers of adults with Alzheimer's disease or related dementias (N = 60) will be randomly assigned in equal numbers to Acceptance and Commitment Therapy delivered by telephone (TACTICs) or minimally-enhanced usual care (mEUC) using a block randomization scheme.
Primary purpose: TREATMENT

Brief summary: Caregivers of adults with dementia report higher distress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases. Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. Results from our recent proof-of-concept study suggest that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. In this study, we will randomize N=60 dementia caregivers in equal numbers to receive either 6 weekly 1-hour telephone-based ACT sessions (TACTICs; experimental) or minimally-enhanced usual care (mEUC; control). We hypothesize that our TACTICs intervention will be feasible and acceptable in this population and will have a greater impact on reducing anxiety and secondary outcomes from baseline to post-intervention, and 3 and 6 months later.

Detailed description: The objective of this pilot randomized controlled trial is to assess feasibility, acceptability, and preliminary effects of Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs) of adults with Alzheimer's disease or related dementias. Using a 2-arm randomized design, we will examine the effects of TACTICs compared to a minimally enhanced usual care group (mEUC) in N=60 dementia caregivers. Primary dementia caregivers with clinically-significant anxiety will be randomized in equal numbers to receive either TACTICs or mEUC. The specific aims are to: (1) Evaluate the feasibility and acceptability of TACTICs. Feasibility will be assessed using caregiver accrual, retention, and TACTICs session attendance rates. Acceptability will be assessed using a participant-reported satisfaction item administered upon intervention completion. (2) Measure the changes in caregiver anxiety and depressive symptoms, caregiver burden, wellbeing, and psychological flexibility at post-intervention (T2) and 3 months (T3) and 6 months (T4) post-intervention compared to baseline. Caregivers will be recruited from a variety of sources, including the Indiana Alzheimer's Disease Center (IADC), Aging Brain Care program at Eskenazi Health, and Indiana University Health geriatric psychiatry and neurology practices. Study staff will contact potentially-eligible caregivers to assess interest and verify eligibility. After providing informed consent and enrolling in the trial, interested and eligible caregivers will complete baseline measures and be randomly assigned in equal numbers to either the TACTICs intervention (n=30) or to mEUC (n=30) using a block randomization scheme. Randomization will be performed in REDCap using a SAS procedure. All study personnel will be blind to allocation sequence. The unblinded research coordinator will be responsible for randomizing participants in REDCap. The PI, Co-Investigators, and research assistants (i.e., recruiters and outcome assessors) will be blind to intervention assignment to reduce the risk of outcome expectancy bias and to enhance the rigor of the trial.

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 a related dementia (ADRD)
* Self-identifies as ADRD patient's primary caregiver
* Intends to continue caregiving for ADRD patient for ≥12 months
* Clinically-elevated anxiety (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: Change in Baseline Anxiety via Generalized Anxiety Disorder scale-7 (GAD-7)
timeFrame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Secondary outcomes:
measure: Change in Baseline Depressive Symptoms via Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
measure: Change in Baseline Caregiver Burden via Zarit Burden Interview (ZBI)
timeFrame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
measure: Change in Baseline Wellbeing via Experience of Suffering Scale (ESS)
timeFrame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
measure: Change in Baseline Coping via Brief COPE
timeFrame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
measure: Change in Baseline Psychological Flexibility via Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
measure: Change in Baseline Quality of Life via PROMIS Global Health measure
timeFrame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
measure: Change in Baseline Anticipatory Grief via Anticipatory Grief Scale (AGS)
timeFrame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Other outcomes:
measure: Intervention feasibility: accrual rate
timeFrame: baseline
measure: Intervention feasibility: attendance rate
timeFrame: post-intervention
measure: Intervention feasibility: retention rate
timeFrame: 6 months post-intervention
measure: Intervention acceptability
timeFrame: post-intervention
measure: Health care and resource utilization
timeFrame: baseline, post-intervention, 3 months post-intervention, 6 months post-intervention
Locations:
city: Indianapolis
country: United States
facility: Regenstrief Institute, Inc.
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Shelley A. Johns, PsyD
role: PRINCIPAL_INVESTIGATOR
References: