Mindfulness-Based Stress Reduction (MBSR) for People High on the Personality Trait Sensory Processing Sensitivity: A Mixed Methods Study

NCT ID: NCT06390020

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sensory Processing Sensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Participants instructed not to partake in any (similar) mindfulness or meditation training.

Group Type NO_INTERVENTION

No interventions assigned to this group

MBSR training

Group Type EXPERIMENTAL

MBSR

Intervention Type OTHER

The MBSR training spans eight weeks and follows a standardized protocol. It consists of eight weekly sessions, each lasting 2.5 hours, a single 6-hour silent day, and daily home exercises. Additionally, the program incorporates personalized psychoeducation on high sensory processing sensitivity, covering its characteristics, scientific foundations, its relation with stress-related symptoms, and why mindfulness might be helpful.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MBSR

The MBSR training spans eight weeks and follows a standardized protocol. It consists of eight weekly sessions, each lasting 2.5 hours, a single 6-hour silent day, and daily home exercises. Additionally, the program incorporates personalized psychoeducation on high sensory processing sensitivity, covering its characteristics, scientific foundations, its relation with stress-related symptoms, and why mindfulness might be helpful.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anne Speckens, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Radboudumc, Centre for Mindfulness

Corina Greven, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Donders Centre for Cognitive Neuroimaging

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Radboudumc Center for Mindfulness

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anne Speckens, prof. dr.

Role: primary

(024) 36 68 456

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30639671 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL84880.091.23

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mindfulness-Based Approaches to Insomnia
NCT00768781 COMPLETED PHASE2