A mindfulness-based stress management program for caregivers of allogeneic hematopoietic stem cell transplant (HCT) patients: Protocol for a randomized controlled trial.
Min-Jeong Yang, Valerie V Yepez, Karen O Brandon, Maija Reblin, Joseph Pidala, Heather S L Jim, Jerrold S. Meyer, L Robert Gore, Nandita Khera, Penny Lau, Rachel M Sauls, Sarah R Jones, Christine Vinci
PLoS One April 1, 2022 DOI: 10.1371/journal.pone.0266316 (opens in new tab)
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Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Pilot study Peer reviewed |
|---|---|
| Population | Caregivers of allogeneic hematopoietic stem cell transplant cancer patients, plus the patients themselves (patients enrolled for assessments only) |
| Duration | 6-week intervention with assessments at baseline, end of treatment, and 2- and 6-months post-treatment |
| Topics | Meditation |
| Keywords | Humans Hydrocortisone Pilot projects Caregivers |
| Registration | NCT05078229 |
| Key findings | The protocol describes a planned three-arm randomized trial testing whether the six-week FOCUS mindfulness-based stress management program lowers post-treatment caregiver burden and improves patient health outcomes relative to Healthy Living and enhanced usual care. The authors hypothesize that FOCUS caregivers will report lower burden and that their patients will have better health outcomes. Recruitment is ongoing and no outcome data are reported. |
Abstract
Objectives: Caregivers of allogeneic hematopoietic stem cell transplant (HCT) cancer patients experience high caregiver burden and carry a significant amount of responsibility. Mindfulness has the potential to lessen caregiver burden by aiding in stress management. To date, no studies have examined the efficacy of mindfulness in reducing caregiver burden in this population. Based on our pilot study demonstrating initial feasibility and acceptability of FOCUS (Focusing On mindfulness for Caregivers Under Stress), this 3-arm randomized controlled trial aims to examine the efficacy of a 6-week mindfulness-based stress management program for allogeneic HCT caregivers. Hypotheses include that the FOCUS condition will have lower post-treatment caregiver burden and that patients of these caregivers will have better patient health outcomes compared to other treatment conditions.
Method: Eligible caregivers will be randomly assigned to one of three treatment conditions: FOCUS, Healthy Living (HL; active control), and Enhanced Care (EC; usual care). Caregivers in FOCUS and HL will participate in 6-week weekly individual treatment sessions and will be sent brief daily momentary interventions/messages. Caregivers in all conditions will complete daily diaries over the course of treatment. Patients of enrolled caregivers will be enrolled for assessments only. Participants will complete assessments at baseline, end of treatment, 2- and 6-months post-treatment. Biomarker data will be collected via hair cortisol concentrations from caregivers at baseline and 6 months post-treatment.
Results: Recruitment is ongoing.
Conclusions: The data collected from this study will provide evidence on the efficacy of mindfulness in alleviating HCT caregiver stress and impacting patient health outcomes.
Trial Registration: The current study is registered in clinicaltrials.gov (NCT05078229); see https://clinicaltrials.gov/ct2/show/NCT05078229?term=christine+vinci&draw=2&rank=1.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 8
- The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology 2003
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective Perspectives on Psychological Science October 14, 2011
- How Does Mindfulness Training Affect Health? A Mindfulness Stress Buffering Account Current Directions in Psychological Science December 1, 2014
- An empirical study of the mechanisms of mindfulness in a mindfulness‐based stress reduction program Journal of Clinical Psychology March 6, 2009
and 3 more in the library