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Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With ADRD ((TACTICs))

Primary Purpose

Anxiety, Caregiver Burden

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Dementia, Alzheimer's disease, Caregiving, Caregiver, Anxiety, Telehealth

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TACTICs

Minimally Enhanced Usual Care

Arm Description

Our ACT intervention will include 6 weekly 1-hour telephone sessions and 1 booster session offered 1 month after session 6 designed to increase psychological flexibility through practice of one or more of the six skills in each session. Although these are ideally spaced 1 week apart, participants will have up to 12 weeks to complete the 6 sessions. Each session will include guided mindfulness practice that encourages non-judgmental awareness of the present moment to increase psychological flexibility; brief (10-minute) study-provided audio recordings will enable participants to practice mindfulness at home. Caregivers will also identify deeply-held values to serve as a guide when choosing how to spend limited time or energy and will set values-based action goals each week. A booster session will be provided one month after session 6 to reinforce skills learned.

All caregivers randomized to the mEUC group will receive a mailed packet containing 1) a letter from the Co-PIs thanking them for participating, 2) printed selections from of the NIH Alzheimer's caregiving website (https://www.nia.nih.gov/health/alzheimers/caregiving), and 3) a listing of Alzheimer's Association sponsored support groups closest to the caregiver's home address. Caregivers will also receive a brief phone call from the research coordinator to verify receipt of the packet. Since this is a usual care group with a minimally-enhanced component, it will be up to the mEUC participants to decide whether or not to engage with these intervention materials.

Outcomes

Primary Outcome Measures

Generalized Anxiety Disorder Scale (GAD-7)
The Generalized Anxiety Disorder Scale (GAD-7) 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

Full Information

First Posted
February 25, 2021
Last Updated
August 31, 2022
Sponsor
Indiana University
Collaborators
Cleveland State University
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1. Study Identification

Unique Protocol Identification Number
NCT04780178
Brief Title
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With ADRD
Acronym
(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 (RRF)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Cleveland State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Caregiver Burden
Keywords
Dementia, Alzheimer's disease, Caregiving, Caregiver, Anxiety, Telehealth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to receive either the TACTICs telephone therapy or the minimally enhanced usual care packet of information.
Masking
Outcomes Assessor
Masking Description
Outcome assessors are blinded to participant group assignment.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TACTICs
Arm Type
Experimental
Arm Description
Our ACT intervention will include 6 weekly 1-hour telephone sessions and 1 booster session offered 1 month after session 6 designed to increase psychological flexibility through practice of one or more of the six skills in each session. Although these are ideally spaced 1 week apart, participants will have up to 12 weeks to complete the 6 sessions. Each session will include guided mindfulness practice that encourages non-judgmental awareness of the present moment to increase psychological flexibility; brief (10-minute) study-provided audio recordings will enable participants to practice mindfulness at home. Caregivers will also identify deeply-held values to serve as a guide when choosing how to spend limited time or energy and will set values-based action goals each week. A booster session will be provided one month after session 6 to reinforce skills learned.
Arm Title
Minimally Enhanced Usual Care
Arm Type
No Intervention
Arm Description
All caregivers randomized to the mEUC group will receive a mailed packet containing 1) a letter from the Co-PIs thanking them for participating, 2) printed selections from of the NIH Alzheimer's caregiving website (https://www.nia.nih.gov/health/alzheimers/caregiving), and 3) a listing of Alzheimer's Association sponsored support groups closest to the caregiver's home address. Caregivers will also receive a brief phone call from the research coordinator to verify receipt of the packet. Since this is a usual care group with a minimally-enhanced component, it will be up to the mEUC participants to decide whether or not to engage with these intervention materials.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias
Other Intervention Name(s)
TACTICs
Intervention Description
A telephone-based acceptance and commitment therapy for caregivers
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder Scale (GAD-7)
Description
The Generalized Anxiety Disorder Scale (GAD-7) 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.
Time Frame
Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Other Pre-specified Outcome Measures:
Title
Patient Health Questionnaire-8
Description
8-item Patient Health Questionnaire-8 assesses depressive symptoms. With total scores ranging from 0 to 24, scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-8 has factorial validity for the diagnosis of major depressive disorder.
Time Frame
Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Title
Zarit Burden Interview
Description
The Zarit Burden Interview is a two-factor, 22-item scale that 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.
Time Frame
Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Title
Experience of Suffering Scale
Description
The Experience of Suffering Scale 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.
Time Frame
Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Title
Multidimensional Psychological Flexibility Inventory
Description
The 24-item Multidimensional Psychological Flexibility Inventory - Short form measures psychological flexibility and inflexibility. Respondents rate how true each statement is for them on a 6-point Likert-type scale anchored from 1=never true to 6=always true. Higher scores indicate higher levels of the dimension being assessed (i.e., psychological flexibility, psychological inflexibility).
Time Frame
Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Title
Satisfaction with Life Scale
Description
The 5-item Satisfaction with Life Scale measures wellbeing. On a 7-point scale, participants indicate how much they agree or disagree with each of the 5 items to assess cognitive judgments of life satisfaction.
Time Frame
Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Title
Quality of Life in Alzheimer's Disease
Description
Quality of Life in Alzheimer's Disease measures caregiver reported measure about the patient's quality of life and will provide preliminary data on the potential impact of the intervention on the person with ADRD for whom enrolled caregiver is caring for.
Time Frame
Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Title
Intervention Acceptability
Description
Intervention acceptability is measured at T2 using an investigator-created 5-item measure of quantitative and qualitative satisfaction items.
Time Frame
Post-intervention (7-9 weeks post-baseline)
Title
Health Care and Resource Utilization
Description
Health care and resource utilization will be measured using an investigator-created 8-item measure. Items will assess caregiver-reported health and mental care utilization (e.g., emergency department [ED], inpatient, outpatient) and services accessed or used to support their caregiving (e.g., support groups, respite care, in-home aid).
Time Frame
Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Title
Inventory of Complicated Grief
Description
The 19-item Inventory of Complicated Grief measures post death grief and bereavement in participants who have lost their loved one with dementia during the study. Each item is rated on a 5-point Likert scale with responses ranging from "never" to "always".
Time Frame
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
Title
Anticipatory grief
Description
the Anticipatory Grief Scale (AGS),43 a 27-item self-report tool designed to assess anticipatory grief of dementia caregivers. Items are scored on a 5-point Likert scale with responses ranging from "strongly disagree" to "strongly agree."
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole R Fowler, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IUH
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In future manuscripts, the authors will list contact information and state that the IPD is available upon request

Learn more about this trial

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

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