Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC)

Dementia Clinical Trial

— PAACC  

Official title:

Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC): A Randomized Controlled Trial on the Effectiveness of a Mindfulness Based Caregiver Multicomponent Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447860
• Other study ID #: MS0010
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: November 12, 2023

Study information

• Verified date: February 2024
• Source: Salem Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Primary objective of the study is to evaluate the effectiveness of mindfulness based caregiver intervention, Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC) compared to an established cognitive behavior therapy based dementia caregiver intervention, Resources for Enhancing Alzheimer's Caregiver Health (REACH) in improving caregiver burden and quality of life of care recipient.

Description:

The study is a randomized controlled trial comparing a mindfulness-enhanced evidence-based caregiver skill-building intervention (PAACC) to REACH-VA to reduce caregiver burden and increase quality of life of the care recipient. For this, caregivers of persons with ADRD or TBI-AD who have moderate to severe burden will be randomly assigned to either receive PAACC or receive REACH-VA. Both the interventions will include 4 biweekly sessions delivered by trained interventionists, followed by an outcome testing session after the intervention. Outcomes of caregiver stress, health and well being will be assessed at baseline and at the end of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: November 12, 2023
• Est. primary completion date: November 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Caregivers will include family members living with the individual diagnosed with Alzheimer's Disease( AD) or Alzheimer's disease related dementia(ADRD) or Traumatic Brain Injury -AD(TBI-AD) with moderate to severe caregiver burden .

• Care recipients with diagnosis of Diagnosis of AD or ADRD or TBI-related AD .

Exclusion Criteria:

• Care givers: Determined to be an imminent risk to self or others,the Care recipient currently resides in a nursing home or assisted living facilities, unable to provide their own consent to participate in the study , and active substance use disorder in the last 1yr.

• Care recipient: Determined to be an imminent risk to self or others, Caregiver is not interested in the study, unable to obtain informed consent from the Care recipient

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• PAACC
Mindfulness based caregiver intervention that includes education , problem solving, skill building, stress management and mindfulness to help enhance compassion and acceptance of self and others
• REACH-VA
A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress

Locations

Country	Name	City	State
United States	VA Boston Health Care system	Brockton	Massachusetts
United States	Salem VAMC	Salem	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Salem Veterans Affairs Medical Center	United States Department of Defense, VA Boston Healthcare System, Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress Scale	The Perceived Stress Scale (PSS) is a 10-item self-report scale developed to measure the degree to which each participant perceives and appraises recent life events as stressful	4-6 weeks