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Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias: A Pilot Randomized Controlled Trial (TACTICs)

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ClinicalTrials.gov Identifier: NCT04338750
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Collaborators:
Indiana Clinical and Translational Sciences Institute
Regenstrief Institute, Inc.
Information provided by (Responsible Party):
Shelley Johns, Indiana University

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=50 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.

Condition or disease Intervention/treatment Phase
Anxiety Anxiety Generalized Anxiety Disorders and Symptoms Caregiver Burnout Behavioral: Telephone Acceptance and Commitment Therapy Intervention for Caregivers Behavioral: minimally-Enhanced Usual Care Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Principal Investigator and Outcomes Assessors are blinded to randomization sequence and randomization assignments for the duration of the study.
Primary Purpose: Treatment
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
Actual Study Start Date : March 24, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Experimental: TACTICs
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of adults with dementia (TACTICs)
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.
Other Name: TACTICs

Active Comparator: mEUC
minimally-Enhanced Usual Care (mEUC)
Behavioral: minimally-Enhanced Usual Care
Participants randomized to mEUC will receive information about dementia caregiver support groups near their home and educational, science-based reading and resources from the National Institute on Aging from the National Institutes of Health.
Other Name: mEUC




Primary Outcome Measures :
  1. Change in Baseline Anxiety via Generalized Anxiety Disorder scale-7 (GAD-7) [ Time Frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention ]
    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.


Secondary Outcome Measures :
  1. Change in Baseline Depressive Symptoms via Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention ]
    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.

  2. Change in Baseline Caregiver Burden via Zarit Burden Interview (ZBI) [ Time Frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention ]
    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.

  3. Change in Baseline Wellbeing via Experience of Suffering Scale (ESS) [ Time Frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention ]
    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.

  4. Change in Baseline Coping via Brief COPE [ Time Frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention ]
    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.

  5. Change in Baseline Psychological Flexibility via Acceptance and Action Questionnaire-II (AAQ-II) [ Time Frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention ]
    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.

  6. Change in Baseline Quality of Life via PROMIS Global Health measure [ Time Frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention ]
    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.

  7. Change in Baseline Anticipatory Grief via Anticipatory Grief Scale (AGS) [ Time Frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention ]
    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."


Other Outcome Measures:
  1. Intervention feasibility: accrual rate [ Time Frame: baseline ]
    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.

  2. Intervention feasibility: attendance rate [ Time Frame: post-intervention ]
    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.

  3. Intervention feasibility: retention rate [ Time Frame: 6 months post-intervention ]
    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.

  4. Intervention acceptability [ Time Frame: post-intervention ]
    We will assess intervention acceptability using a brief investigator-created battery of quantitative and qualitative satisfaction items.

  5. Health care and resource utilization [ Time Frame: baseline, post-intervention, 3 months post-intervention, 6 months post-intervention ]
    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).



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338750


Contacts
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Contact: Patrick V Stutz, BA 3172749484 pstutz@iupui.edu
Contact: Nicole R Fowler, PhD 3172749021 fowlern@iupui.edu

Locations
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United States, Indiana
Regenstrief Institute, Inc. Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Patrick V Stutz, BA    317-274-9484    pstutz@iupui.edu   
Principal Investigator: Shelley A Johns, PsyD         
Sponsors and Collaborators
Indiana University
Indiana Clinical and Translational Sciences Institute
Regenstrief Institute, Inc.
Investigators
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Principal Investigator: Shelley A Johns, PsyD Indiana University
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Responsible Party: Shelley Johns, Assistant Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT04338750    
Other Study ID Numbers: 2002468698
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In future manuscripts, the authors will list contact information and state that IPD is available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shelley Johns, Indiana University:
Alzheimer's disease
Dementia
Caregiving
Caregiver
Anxiety
Acceptance and commitment therapy
Telehealth
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Anxiety Disorders
Burnout, Psychological
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Stress, Psychological
Behavioral Symptoms