DementiaPAACCNCT03447860
Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC)
A study testing PAACC and REACH-VA in people with Dementia, run by Salem Veterans Affairs Medical Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- PAACC and REACH-VA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jun 2018to 12 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Boston Health Care system
Brockton, Massachusetts, 02301
Salem VAMC
Salem, Virginia, 24153
About this study
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
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- PAACC, REACH-VA
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAACCBehavioural
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-VABehavioural
A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress
| Study group | Role | What they receive |
|---|---|---|
| REACH-VA | Active comparator | A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress. Receives: Behavioral: REACH-VA |
| PAACC | Experimental | A mindfulness-based multi-component caregiver intervention to reduce caregiver stress. Receives: Behavioral: PAACC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start25 Jun 2018
- Primary completion12 Nov 2023
- Study completion12 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salem Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- VA Boston Healthcare System, Virginia Polytechnic Institute and State University, United States Department of Defense
- Responsible party
- Principal investigator, Mamta Sapra, Salem Veterans Affairs Medical Center
- Investigators
- Mamta Sapra, MD, Principal investigator, Salem VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447860
- Sponsor's protocol ID
- MS0010
- Acronym
- PAACC
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2018
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savla J, Mansoor M, Kim N, Hagemann L, Luci K, Sapra M. Mindfulness and rumination: stress pathways for caregivers of persons living with dementia. Gerontologist. 2026 Jun 9;66(7):gnag103. doi: 10.1093/geront/gnag103.
PubMed 42159557
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03447860
- Acronym / sponsor ID
- PAACC / MS0010
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Salem Veterans Affairs Medical CenterUS federal agency
- Collaborators
- VA Boston Healthcare System, Virginia Polytechnic Institute and State University, United States Department of Defense
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 12 Nov 2023 (actual)
- Study completion
- 12 Nov 2023 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REACH-VA | Active comparator | Behavioral: REACH-VAA cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress. |
| PAACC | Experimental | Behavioral: PAACCA mindfulness-based multi-component caregiver intervention to reduce caregiver stress. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAACCMindfulness based caregiver intervention that includes education , problem solving, skill building, stress management and mindfulness to help enhance compassion and acceptance of self and others | Behavioural | PAACC |
| REACH-VAA cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress | Behavioural | REACH-VA |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 42159557Savla J, Mansoor M, Kim N, Hagemann L, Luci K, Sapra M. Mindfulness and rumination: stress pathways for caregivers of persons living with dementia. Gerontologist. 2026 Jun 9;66(7):gnag103. doi: 10.1093/geront/gnag103.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mamta Sapra, MD principal investigator
Salem VAMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAACC and REACH-VA in people with Dementia, run by Salem Veterans Affairs Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.