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Possible Therapy by Phone for Caregivers (TACTICs)

Primary Purpose

Anxiety, Anxiety Disorders and Symptoms, Caregiver Burnout

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT Acceptance and Commitment Therapy
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 Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Acceptance and commitment therapy, Telehealth

Eligibility Criteria

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

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 related dementia (DARD)
  • Intends to continue caregiving form ADRD patient for at least 12 months or greater
  • Clinically elevated anxiety score (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

Sites / Locations

  • Regenstrief Institute, Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Experimental TACTICs

Arm Description

Telephone Acceptance and Commitment Therapy Intervention for Caregivers of adults with dementia (TACICS. Participants will receive a manualized acceptance and commitment therapy intervention delivered via phone in 6 weekly 1 hour sessions by a trained interventionalist

Outcomes

Primary Outcome Measures

Anxiety symptoms measured by the Generalized Anxiety Disorder Scale (GAD-7)
Anxiety will be measured using the GAD-7 which contains 7 items with total scores ranging from 0 to 21. Scores of 5, 10 and 15 are cut off scores 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

Depressive symptoms measured by the Patient Health Questionnarie-9 (PHQ-9)
Depressive symptoms will be measured using the 9 item Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms. With total scores ranging from 0-27. 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
Caregiver burden measured by the Zarit Burden Interview (ZBI)
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
Physical, emotional and existential suffering to caregivers measured by the Experience of Suffering Scale (ESS)
Well being will be measured using the (ESS). With prior testing in ADRD caregivers, the ESS contains 33 items across 3 subscales: physical (9items), psychological (15 items), and existential (9 items) suffering. Total scores for each subscale are calculated with higher scores indicating more suffering within each domain
Different strategies that caregivers use to cope measured with the Brief COPE
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
Caregivers psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II)
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
Overall quality of life will be measured with the NIH PROMIS Global Health measure
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
Caregivers grief during active caregiving will be measured with the Anticipatory Grief Scale (AGS)
Anticipatory grief will be measured by the AGS, a 27 item self report tool designed to assess the bereavement experience of dementia caregivers. Items are scored on a 5-point Likert type scale with responses ranging from "strongly disagree" to "strongly agree".

Full Information

First Posted
November 3, 2020
Last Updated
March 27, 2023
Sponsor
Indiana University
Collaborators
Regenstrief Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04634396
Brief Title
Possible Therapy by Phone for Caregivers
Acronym
TACTICs
Official Title
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias. A Single Arm Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2019 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Regenstrief Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Caregivers of adults with dementia report higher stress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases.
Detailed Description
Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. The Investigators are trying to determine proof of concept that suggests that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. This study will recruit N=20 dementia caregivers to receive 6 weekly 1-hour telephone-based ACT sessions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Anxiety Disorders and Symptoms, Caregiver Burnout
Keywords
Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Acceptance and commitment therapy, Telehealth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single arm proof of concept study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental TACTICs
Arm Type
Other
Arm Description
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of adults with dementia (TACICS. Participants will receive a manualized acceptance and commitment therapy intervention delivered via phone in 6 weekly 1 hour sessions by a trained interventionalist
Intervention Type
Behavioral
Intervention Name(s)
ACT Acceptance and Commitment Therapy
Intervention Description
6 weeks of 1 hour sessions with a masters prepared research specialist to deliver validated tools
Primary Outcome Measure Information:
Title
Anxiety symptoms measured by the Generalized Anxiety Disorder Scale (GAD-7)
Description
Anxiety will be measured using the GAD-7 which contains 7 items with total scores ranging from 0 to 21. Scores of 5, 10 and 15 are cut off scores 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
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Depressive symptoms measured by the Patient Health Questionnarie-9 (PHQ-9)
Description
Depressive symptoms will be measured using the 9 item Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms. With total scores ranging from 0-27. 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
Time Frame
through study completion, an average of 6 months
Title
Caregiver burden measured by the Zarit Burden Interview (ZBI)
Description
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
Time Frame
through study completion, an average of 6 months
Title
Physical, emotional and existential suffering to caregivers measured by the Experience of Suffering Scale (ESS)
Description
Well being will be measured using the (ESS). With prior testing in ADRD caregivers, the ESS contains 33 items across 3 subscales: physical (9items), 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
through study completion, an average of 6 months
Title
Different strategies that caregivers use to cope measured with the Brief COPE
Description
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
Time Frame
through study completion, an average of 6 months
Title
Caregivers psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II)
Description
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
Time Frame
through study completion, an average of 6 months
Title
Overall quality of life will be measured with the NIH PROMIS Global Health measure
Description
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
Time Frame
through study completion, an average of 6 months
Title
Caregivers grief during active caregiving will be measured with the Anticipatory Grief Scale (AGS)
Description
Anticipatory grief will be measured by the AGS, a 27 item self report tool designed to assess the bereavement experience of dementia caregivers. Items are scored on a 5-point Likert type scale with responses ranging from "strongly disagree" to "strongly agree".
Time Frame
through study completion, an average of 6 months
Other Pre-specified Outcome Measures:
Title
The feasibility of the TACTICs Intervention will be measured by accrual rate, attendance of sessions, and the retention in the study
Description
The investigators will assess the number of eligibly screened caregivers who choose to consent and enroll in the pilot study, assess the total number of sessions that participants attend the number of enrolled subjects completing the outcome assessments.
Time Frame
baseline and through study completion, an average of 6 months.
Title
Caregivers acceptability of the TACTICs intervention
Description
The investigators will assess intervention acceptability using a brief investigator created battery of qualitative and quantitative satisfaction items
Time Frame
through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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 related dementia (DARD) Intends to continue caregiving form ADRD patient for at least 12 months or greater Clinically elevated anxiety score (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelley A. Johns, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regenstrief Institute, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-4800
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 IPD is available upon request
IPD Sharing Time Frame
Spring, 2021
IPD Sharing Access Criteria
manuscripts

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Possible Therapy by Phone for Caregivers

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