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

NCT ID: NCT03447860

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2023-11-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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REACH-VA

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

Group Type ACTIVE_COMPARATOR

REACH-VA

Intervention Type BEHAVIORAL

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

PAACC

A mindfulness-based multi-component caregiver intervention to reduce caregiver stress.

Group Type EXPERIMENTAL

PAACC

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

REACH-VA

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Boston Healthcare System

FED

Sponsor Role collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

Salem Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Mamta Sapra

Geriatric psychiatrist, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mamta Sapra, MD

Role: PRINCIPAL_INVESTIGATOR

Salem VAMC

Locations

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VA Boston Health Care system

Brockton, Massachusetts, United States

Site Status

Salem VAMC

Salem, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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MS0010

Identifier Type: -

Identifier Source: org_study_id

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