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Completed

NCT Number: NCT03447860

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Health Care system, Brockton, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAACC

Behavioral

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

Behavioral

A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress

Primary outcomes

  1. Perceived Stress Scale

    Time frame: 4-6 weeks

    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

Sponsors and collaborators

Lead sponsor

Salem Veterans Affairs Medical Center

Fed

Collaborators

  • United States Department of Defense
  • VA Boston Healthcare System
  • Virginia Polytechnic Institute and State University

Registry information

Official study title

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

Acronym: PAACC

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2018
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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