Possible Therapy by Phone for Caregivers (TACTICs)

Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias. A Single Arm Pilot

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Anxiety Disorders and Symptoms; Caregiver Burnout
• Intervention / Treatment: Behavioral: ACT Acceptance and Commitment Therapy

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202-4800
      • Regenstrief Institute, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Experimental TACTICs; 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	Behavioral: ACT Acceptance and Commitment Therapy; 6 weeks of 1 hour sessions with a masters prepared research specialist to deliver validated tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 6 months
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	through study completion, an average of 6 months
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	through study completion, an average of 6 months
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	through study completion, an average of 6 months
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	through study completion, an average of 6 months
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	through study completion, an average of 6 months
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".	through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility of the TACTICs Intervention will be measured by accrual rate, attendance of sessions, and the retention in the study	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.	baseline and through study completion, an average of 6 months.
Caregivers acceptability of the TACTICs intervention	The investigators will assess intervention acceptability using a brief investigator created battery of qualitative and quantitative satisfaction items	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Regenstrief Institute, Inc.
• Investigators: Principal Investigator: Shelley A. Johns, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2019
• Primary Completion (Actual): December 9, 2019
• Study Completion (Actual): December 9, 2019

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Alzheimer's disease; Dementia; Telehealth; Caregiver; Caregiving; Acceptance and commitment therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Stress, Psychological; Anxiety Disorders; Caregiver Burden
• Other Study ID Numbers: 1904631305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• 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