NCT04977245: MBSR

Mindfulness-Based Stress Reduction in Dementia Caregivers

Completed NA Last updated 28 April 2022

What this trial tests

NA trial testing Mindfulness-Based Stress Reduction in Mindfulness Based Stress Reduction in 40 participants. Completed in 4 April 2022.

Timeline

12 August 2021

Primary endpoint
4 April 2022

4 April 2022

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	40
Start date	12 August 2021
Primary completion	4 April 2022
Estimated completion	4 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness-Based Stress Reduction
• Self-Guided Mindfulness eCourse

Conditions studied

• Mindfulness Based Stress Reduction — all drugs for Mindfulness Based Stress Reduction →
• Caregiver Burnout — all drugs for Caregiver Burnout →
• Caregiver Stress Syndrome — all drugs for Caregiver Stress Syndrome →
• Dementia — all drugs for Dementia →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Mindfulness Based Stress Reduction or Caregiver Burnout. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aims: The study will contribute to our understanding of how the cultivation of caregiver mindfulness might improve their overall relational well-being (Primary Outcome), their psychological well-being (Secondary Outcome), and have an impact on dementia patients' lifestyles (Other Outcome). Overall, this study will investigate the idea that the fruits of mindfulness training can be leveraged by both the caregiver and the care-recipient, improving the quality of relationship by making their interactions more mutual, connected, empathic and positive. This study aims to additionally elucidate which facets of mindfulness account for caregiver's happiness and psychological well-being.

Sample: In this study 40 dementia caregivers will be recruited to participate; 20 will be allocated to the clinical intervention group (i.e., adapted MBSR for caregivers) and 20 to the active control group. Data will be collected pre-post the start of intervention, and at a 3 month follow up.

Future orientation: This study may contribute to evidence-based knowledge concerning the efficacy of mindfulness based interventions to support caregiver empowerment, via regaining relationship satisfaction and achieving greater equanimity in the face of stressors.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A mindfulness-based intervention adapted to dementia caregivers: A study protocol for a randomized clinical control trial.
   Antoniou R, Toli DG, Lerner H, Callahan P, et al · · 2022 · cited 1× · PMID 36605275 · DOI 10.3389/fpsyg.2022.1062452