Possible Therapy by Phone for Caregivers (TACTICs)

• ClinicalTrials.gov Identifier: NCT04634396
• Recruitment Status: Completed
• First Posted: November 18, 2020
• Last Update Posted: November 18, 2020
• Sponsor: Indiana University
• Collaborator: Regenstrief Institute, Inc.
• Information provided by (Responsible Party): Nicole R. Fowler, PhD, Indiana University

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.

Condition or disease	Intervention/treatment	Phase
Anxiety; Anxiety Disorders and Symptoms; Caregiver Burnout	Behavioral: ACT Acceptance and Commitment Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: single arm proof of concept study
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias. A Single Arm Pilot
• Actual Study Start Date: June 14, 2019
• Actual Primary Completion Date: December 9, 2019
• Actual Study Completion Date: December 9, 2019

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Anxiety symptoms measured by the Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: through study completion, an average of 6 months ]
   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 :

1. Depressive symptoms measured by the Patient Health Questionnarie-9 (PHQ-9) [ Time Frame: through study completion, an average of 6 months ]
   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
2. Caregiver burden measured by the Zarit Burden Interview (ZBI) [ Time Frame: through study completion, an average of 6 months ]

   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. Physical, emotional and existential suffering to caregivers measured by the Experience of Suffering Scale (ESS) [ Time Frame: through study completion, an average of 6 months ]
   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
4. Different strategies that caregivers use to cope measured with the Brief COPE [ Time Frame: through study completion, an average of 6 months ]
   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. Caregivers psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II) [ Time Frame: through study completion, an average of 6 months ]
   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. Overall quality of life will be measured with the NIH PROMIS Global Health measure [ Time Frame: through study completion, an average of 6 months ]
   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. Caregivers grief during active caregiving will be measured with the Anticipatory Grief Scale (AGS) [ Time Frame: through study completion, an average of 6 months ]
   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".

Other Outcome Measures:

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

Eligibility Criteria

• 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 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

Contacts and Locations

Locations

United States, Indiana

Regenstrief Institute, Inc.

Indianapolis, Indiana, United States, 46202-4800

Sponsors and Collaborators

Indiana University

Regenstrief Institute, Inc.

Investigators

• Principal Investigator: Shelley A. Johns, PhD; Indiana University

More Information

• Responsible Party: Nicole R. Fowler, PhD, Associate Professor of Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT04634396
• Other Study ID Numbers: 1904631305
• First Posted: November 18, 2020
• Last Update Posted: November 18, 2020
• Last Verified: November 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
• Time Frame: Spring, 2021
• Access Criteria: manuscripts

• 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

Keywords provided by Nicole R. Fowler, PhD, Indiana University:

Alzheimer's disease; Dementia; Caregiving; Caregiver; Anxiety; Acceptance and commitment therapy; Telehealth

Additional relevant MeSH terms:

Anxiety Disorders; Caregiver Burden; Mental Disorders; Stress, Psychological; Behavioral Symptoms