Possible Therapy by Phone for Caregivers

Anxiety Clinical Trial

— TACTICs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04634396
• Other study ID #: 1904631305
• Status: Completed
• Phase: N/A
• Start date: June 14, 2019
• Est. completion date: December 9, 2019

Study information

• Verified date: March 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Caregiver Burden
• Caregiver Burnout

Intervention

Behavioral:
• ACT Acceptance and Commitment Therapy
6 weeks of 1 hour sessions with a masters prepared research specialist to deliver validated tools

Locations

Country	Name	City	State
United States	Regenstrief Institute, Inc.	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Regenstrief Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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