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

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ClinicalTrials.gov Identifier: NCT03447860
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
VA Boston Healthcare System
Virginia Polytechnic Institute and State University
United States Department of Defense
Information provided by (Responsible Party):
Mamta Sapra, Salem Veterans Affairs Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: PAACC Behavioral: REACH-VA Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Active Comparator: REACH-VA
A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress.
Behavioral: REACH-VA
A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress

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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447860


Contacts
Contact: Frances Hickman 5409822463 ext 1207 frances.hickman3@va.gov

Locations
United States, Massachusetts
VA Boston Health Care system Not yet recruiting
Brockton, Massachusetts, United States, 02301
Contact: Lindsey Jacobs, PhD         
United States, Virginia
Salem VAMC Recruiting
Salem, Virginia, United States, 24153
Contact: Mamta Sapra, MD    540-982-2463 ext 1453    mamta.sapra@va.gov   
Contact: Tonda Yates, LPN    5409822463 ext 1534    tonda.yates@va.gov   
Salem Veteran Affairs Medical Center Not yet recruiting
Salem, Virginia, United States, 24153
Contact: Mamta Sapra, MD    540-982-2463 ext 1453    mamta.sapra@va.gov   
Sponsors and Collaborators
Salem Veterans Affairs Medical Center
VA Boston Healthcare System
Virginia Polytechnic Institute and State University
United States Department of Defense
Investigators
Principal Investigator: Mamta Sapra, MD Salem VAMC

Responsible Party: Mamta Sapra, Geriatric psychiatrist, MD, Salem Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03447860     History of Changes
Other Study ID Numbers: MS0010
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders