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

NCT06390020 | Recruiting

• 1 other identifier: NL84880.091.23
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensory Processing Sensitivity

Keywords

Sensory processing sensitivity; Highly sensitive person; Mindfulness-based stress reduction; Mindfulness; Depression; Anxiety; Stress; Self-regulation

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Post-intervention in self-reported depression, anxiety, and stress

  Measured by the Depression, Anxiety and Stress Scale (DASS-21). It has 21 items assessed on a four-point Likert scale (0-3) with a total score ranging from 0 to 63. There are three subscales (Depression, Anxiety and Stress), with each seven items and subscale scores ranging from 0 to 21. The main outcome will be the total score, which is doubled to match the scores of the full version (DASS-42). A higher score indicates more severe symptoms of depression, anxiety, and/or stress.

  Baseline, Post-intervention at approximately 3 months

Secondary Outcomes (11)

• Change from Baseline to Post-intervention in self-reported well-being

  Baseline, Post-intervention at approximately 3 months

• Change from Baseline to Post-intervention in self-reported burnout symptoms

  Baseline, Post-intervention at approximately 3 months

• Change from Baseline to Post-intervention in self-reported physical symptoms

  Baseline, Post-intervention at approximately 3 months

• Change from Baseline to Post-intervention in self-reported overstimulation

  Baseline, Post-intervention at approximately 3 months

• Change from Baseline to Post-intervention in self-reported mindfulness

  Baseline, Post-intervention at approximately 3 months

Study Arms (2)

Control

NO INTERVENTION

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

MBSR training

EXPERIMENTAL

Other: MBSR

Interventions

MBSR 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.

MBSR training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

The Radboudumc Center for Mindfulness

Nijmegen, Gelderland, 6525 GC, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 30639671 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Self-Control

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Social Behavior

Study Officials

• Anne Speckens, prof. dr.

  Radboudumc, Centre for Mindfulness

  PRINCIPAL INVESTIGATOR

• Corina Greven, prof. dr.

  Donders Centre for Cognitive Neuroimaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 29, 2024
• Study Start: January 15, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-03

Locations

NL (1)