ClinicalTrials.gg
CompletedNCT03447860PAACCUpdated Feb 13, 2024

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

An interventional study of PAACC and REACH-VA in Dementia, sponsored by Salem Veterans Affairs Medical Center. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by Salem Veterans Affairs Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Randomized
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Dementia

Browse trials for

03

In context

Dementia

2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.

This study's enrollment of 142 is above the median of 90 across 1,758 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Salem Veterans Affairs Medical Center is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 from the Care recipient
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
142 participants (actual)

Study arms

  • Active comparator
    REACH-VA

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

    Behavioral: REACH-VA

  • Experimental
    PAACC

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

    Behavioral: PAACC

Interventions

  • BehavioralPAACC

    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

  • BehavioralREACH-VA

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4-6 weeks

07

Study locations

2 sites
  • VA Boston Health Care system
    Brockton, Massachusetts 02301, United States
  • Salem VAMC
    Salem, Virginia 24153, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Nov 2023, 64 months.

Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 64 months is above that.

Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2018
First posted
Feb 27, 2018
StartActual
Jun 25, 2018
Primary completionActual
Nov 12, 2023
CompletionActual
Nov 12, 2023
Last update
Feb 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03447860
Lead sponsor
Salem Veterans Affairs Medical Center
Collaborators
VA Boston Healthcare System, Virginia Polytechnic Institute and State University, United States Department of Defense
Responsible party
Mamta Sapra (Geriatric psychiatrist, MD, Salem Veterans Affairs Medical Center) — Principal investigator
First posted
Feb 27, 2018
Start date
Jun 25, 2018
Primary completion
Nov 12, 2023
Completion
Nov 12, 2023
Last update
Feb 13, 2024

Study contacts

Mamta Sapra, MD
principal investigator · Salem VAMC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion