Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Dementia

Anxiety Clinical Trial

— TACTICs  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338750
• Other study ID #: 2002468698
• Status: Completed
• Phase: N/A
• Start date: March 24, 2020
• Est. completion date: April 9, 2021

Study information

• Verified date: July 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 9, 2021
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Anxiety Generalized
• Caregiver Burden
• Caregiver Burnout
• Dementia

Intervention

Behavioral:
• Telephone Acceptance and Commitment Therapy Intervention for Caregivers
Participants randomized to TACTICs will receive a manualized acceptance and commitment therapy intervention delivered via phone in 6 weekly 1-hour sessions by a trained Bachelor's-level interventionist. Participants in this intervention will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' caregiving experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to anxiety and caregiving challenges. Participants will receive handouts on session topics and a CD with guided mindfulness practices.
• minimally-Enhanced Usual Care
Participants randomized to mEUC will receive a letter thanking them for participating in the trial along with the Alzheimer's Caregiving guide from the National Institute of Aging of the National Institutes of Health (https://www.nia.nih.gov/health/alzheimers/caregiving), coupled with a listing of the five Alzheimer's Association sponsored support groups closest to their home address.

Locations

Country	Name	City	State
United States	Regenstrief Institute, Inc.	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Indiana Clinical and Translational Sciences Institute, Regenstrief Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention feasibility: accrual rate	We will assess the number of eligibly-screened caregivers who choose to consent and enroll in the trial. This accrual outcome speaks to intervention feasibility.	baseline
Other	Intervention feasibility: attendance rate	We will assess the total number of sessions that participants allocated to TACTICs attend (i.e., out of 6 sessions possible). This attendance outcome speaks to intervention feasibility.	post-intervention
Other	Intervention feasibility: retention rate	We will assess the number of enrolled subjects completing the final outcome assessment at 6 months post-intervention. This retention outcome speaks to intervention feasibility.	6 months post-intervention
Other	Intervention acceptability	We will assess intervention acceptability using a brief investigator-created battery of quantitative and qualitative satisfaction items.	post-intervention
Other	Health care and resource utilization	Health care and resource utilization will be measured using an investigator-created battery of items. Items will assess caregiver-reported health and mental care utilization (e.g., ED, inpatient, outpatient) and services accessed or used to support their caregiving (e.g., support groups, respite care, in-home aid).	baseline, post-intervention, 3 months post-intervention, 6 months post-intervention
Primary	Change in Baseline Anxiety via Generalized Anxiety Disorder scale-7 (GAD-7)	Changes in anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7), which 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.	baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Secondary	Change in Baseline Depressive Symptoms via Patient Health Questionnaire-9 (PHQ-9)	Changes in depressive symptoms will be measured using the 9-item Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms. With total scores ranging from 0 to 27, scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-9 has factorial validity for the diagnosis of major depressive disorder.	baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Secondary	Change in Baseline Caregiver Burden via Zarit Burden Interview (ZBI)	Changes in caregiver burden will be measured using the Zarit Burden Interview (ZBI). This two-factor, 22-item scale measures personal strain and role strain in caregiving by summing responses to a total score (0-20 little or no burden; 21-40 mild to moderate burden; 41-60 moderate to severe burden; and 61-88 severe burden). The ZBI measures change over time resulting from the progression of the patient's symptoms or from interventions aimed at reducing burden.	baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Secondary	Change in Baseline Wellbeing via Experience of Suffering Scale (ESS)	Changes in wellbeing will be measured using the Experience of Suffering Scale (ESS). With prior testing in ADRD caregivers, the ESS contains 33 items across 3 subscales: physical (9 items), psychological (15 items), and existential (9 items) suffering. Total scores for each subscale are calculated with higher scores indicating more suffering within each domain.	baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Secondary	Change in Baseline Coping via Brief COPE	Changes in coping will be measured with the 28-item Brief COPE, a measure of coping strategies used in response to stressors. Comprised of 28 coping strategies, the Brief COPE contains 14 two-item subscales, each analyzed separately: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, venting, behavioral disengagement, positive reframing, planning, humor, acceptance, religion, and self-blame.	baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Secondary	Change in Baseline Psychological Flexibility via Acceptance and Action Questionnaire-II (AAQ-II)	Changes in psychological flexibility and its opposite, experiential avoidance, will be measured using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Respondents rate how true each statement (e.g., "It is okay if I remember something unpleasant") is for them on a 7-point Likert-type scale anchored from 1=never true to 7=always true. Higher scores indicate greater psychological flexibility or acceptance.	baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Secondary	Change in Baseline Quality of Life via PROMIS Global Health measure	Changes in quality of life will be assessed with the 10-item PROMIS Global Health measure. On a 5-point scale, participants rate their mental and physical well-being with higher scores indicative of better health.	baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Secondary	Change in Baseline Anticipatory Grief via Anticipatory Grief Scale (AGS)	Changes in anticipatory grief will be measured with the Anticipatory Grief Scale (AGS), a 27-item self-report tool designed to assess the bereavement experience of dementia caregivers. Items are scored on a 5-point Likert scale with responses ranging from "strongly disagree" to "strongly agree."	baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention