ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

February 21, 2018
February 27, 2018
September 11, 2018
June 25, 2018
September 2020   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03447860 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC)
Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC): A Randomized Controlled Trial on the Effectiveness of a Mindfulness Based Caregiver Multicomponent Intervention
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Dementia
  • 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
  • Behavioral: REACH-VA
    A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress
  • Active Comparator: REACH-VA
    A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress.
    Intervention: Behavioral: REACH-VA
  • Experimental: PAACC
    A mindfulness-based multi-component caregiver intervention to reduce caregiver stress.
    Intervention: Behavioral: PAACC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Same as current
December 2020
September 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact: Frances Hickman 5409822463 ext 1207 frances.hickman3@va.gov
United States
 
 
NCT03447860
MS0010
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Mamta Sapra, Salem Veterans Affairs Medical Center
Salem Veterans Affairs Medical Center
  • VA Boston Healthcare System
  • Virginia Polytechnic Institute and State University
  • United States Department of Defense
Principal Investigator: Mamta Sapra, MD Salem VAMC
Salem Veterans Affairs Medical Center
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP