Clinical trial NCT06390020: Mindfulness-Based Stress Reduction (MBSR) for People High on the Personality Trait Sensory Processing Sensitivity: A Mixed Methods Study
Official title: Mindfulness-Based Stress Reduction for People High on the Personality Trait Sensory Processing Sensitivity: A Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sensory Processing Sensitivity
Keywords: Sensory processing sensitivity
Highly sensitive person
Mindfulness-based stress reduction
Mindfulness
Depression
Anxiety
Stress
Self-regulation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the efficacy of MBSR training in alleviating stress-related symptoms among individuals with high sensory processing sensitivity. Participants will be randomly allocated to either the MBSR group or the control group.

The primary hypothesis is that participants in the MBSR group, relative to control group, will have lower depression-anxiety-stress scores post-intervention, after controlling for baseline scores. The secondary hypothesis is that in the MBSR group, relative to control group, other mental health, physical health and well-being outcomes, as well as potential mindfulness mechanisms will also improve, after controlling for baseline scores.


Eligibility criteria: Inclusion Criteria:

* Participant has high sensory processing sensitivity (screened for by the Highly Sensitive Person Scale (HSPS) with a mean score of ≥4.4)
* Participant is 18 years or older
* Participant is proficient in Dutch
* Participant lives near the location where the MBSR training takes place (up to about 30km from Nijmegen)
* Participant is able to travel to location of the MBSR training for all sessions
* Participant is available on the scheduled times of the MBSR sessions (or not available for one session with exception of the silent day)

Exclusion Criteria:

* Participant has a severe psychological condition (e.g. psychotic or suicidal)
* Participant has followed mindfulness or meditation training (\~eight-week program) within the previous five years

Primary outcomes:
measure: Change from Baseline to Post-intervention in self-reported depression, anxiety, and stress
timeFrame: Baseline, Post-intervention at approximately 3 months
Secondary outcomes:
measure: Change from Baseline to Post-intervention in self-reported well-being
timeFrame: Baseline, Post-intervention at approximately 3 months
measure: Change from Baseline to Post-intervention in self-reported burnout symptoms
timeFrame: Baseline, Post-intervention at approximately 3 months
measure: Change from Baseline to Post-intervention in self-reported physical symptoms
timeFrame: Baseline, Post-intervention at approximately 3 months
measure: Change from Baseline to Post-intervention in self-reported overstimulation
timeFrame: Baseline, Post-intervention at approximately 3 months
measure: Change from Baseline to Post-intervention in self-reported mindfulness
timeFrame: Baseline, Post-intervention at approximately 3 months
measure: Change from Baseline to Post-intervention in self-reported attention regulation
timeFrame: Baseline, Post-intervention at approximately 3 months
measure: Change from Baseline to Post-intervention in self-reported strategies for cognitive emotion regulation
timeFrame: Baseline, Post-intervention at approximately 3 months
measure: Change from Baseline to Post-intervention in self-reported body awareness
timeFrame: Baseline, Post-intervention at approximately 3 months
measure: Change from Baseline to Post-intervention in self-reported self-compassion
timeFrame: Baseline, Post-intervention at approximately 3 months
measure: Change from Baseline to Post-intervention in self-reported sensory processing sensitivity
timeFrame: Baseline, Post-intervention at approximately 3 months
measure: Perceived facilitators, barriers, effects, and mechanisms of participating in the MBSR training
timeFrame: Post-intervention at approximately 3 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: The Radboudumc Center for Mindfulness
state: Gelderland
Study officials:
affiliation: Radboudumc, Centre for Mindfulness
name: Anne Speckens, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Donders Institute for Brain, Cognition and Behaviour
name: Corina Greven, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greven CU, Lionetti F, Booth C, Aron EN, Fox E, Schendan HE, Pluess M, Bruining H, Acevedo B, Bijttebier P, Homberg J. Sensory Processing Sensitivity in the context of Environmental Sensitivity: A critical review and development of research agenda. Neurosci Biobehav Rev. 2019 Mar;98:287-305. doi: 10.1016/j.neubiorev.2019.01.009. Epub 2019 Jan 9.