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

Anxiety Clinical Trial

— (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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780178
• Other study ID #: 10320
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: August 8, 2022

Study information

• Verified date: August 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Caregiver Burden

Intervention

Behavioral:
• Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias
A telephone-based acceptance and commitment therapy for caregivers

Locations

Country	Name	City	State
United States	IUH	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Cleveland State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Health Questionnaire-8	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.	Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Other	Zarit Burden Interview	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.	Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Other	Experience of Suffering Scale	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.	Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Other	Multidimensional Psychological Flexibility Inventory	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).	Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Other	Satisfaction with Life Scale	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.	Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Other	Quality of Life in Alzheimer's Disease	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.	Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Other	Intervention Acceptability	Intervention acceptability is measured at T2 using an investigator-created 5-item measure of quantitative and qualitative satisfaction items.	Post-intervention (7-9 weeks post-baseline)
Other	Health Care and Resource Utilization	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).	Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month
Other	Inventory of Complicated Grief	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".	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
Other	Anticipatory grief	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."	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
Primary	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.	Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month