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Sensory Processing SensitivityMindSensNCT06390020

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

A study testing MBSR in people with Sensory Processing Sensitivity, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sensory Processing Sensitivity
What is being tested?
MBSR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteNetherlands
Study dates
15 Jan 2024to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting
  • The Radboudumc Center for Mindfulness

    Nijmegen, Gelderland, 6525 GC

    Anne Speckens, prof. dr., (024) 36 68 456, mindfulness@radboudumc.nl

    Recruiting

Other trials in Netherlands

About this study

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

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.

Being tested
MBSR
Keywords
Sensory processing sensitivity, Highly sensitive person, Mindfulness-based stress reduction, Mindfulness, Depression, Anxiety, Stress, Self-regulation
Medical subject headings
Depression, Anxiety Disorders, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBSROther

    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.

Study groups in NCT06390020
Study groupRoleWhat they receive
ControlNo interventionParticipants instructed not to partake in any (similar) mindfulness or meditation training.
MBSR trainingExperimentalNot described
Receives: Other: MBSR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Post-intervention at approximately 3 months

Secondary outcomes (11)
  1. Change from Baseline to Post-intervention in self-reported well-being

    Measured by the Mental Health Continuum - Short Form (MHC-SF). It has 14 items assessed on a six-point Likert scale (0-5) with a total score ranging from 0 to 70. There are three subscales: Emotional well-being (3 items), Social well-being (5 items), and Psychological well-being (6 items). Score combinations across these subscales can be used to distinguish between the following subgroups: flourishing, moderate, and languishing. Higher scores indicate a better well-being.

    Measured: Baseline, Post-intervention at approximately 3 months

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

    Measured by the Burnout Assessment Tool - Short Form (BAT-12). It has 12 items assessed on a five-point Likert scale (1-5) with a mean total score ranging from 1 to 5. There are four subscales: Exhaustion, Mental Distance, Emotional Impairment, and Cognitive Impairment (3 items each). Mean subscale scores range from 1 to 5. Higher scores indicate more severe burnout symptoms.

    Measured: Baseline, Post-intervention at approximately 3 months

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

    Measured by the Cohen - Hoberman Inventory of Physical Symptoms (CHIPS). It has 33 items assessed on a five-point Likert scale (0-4) with a total score of 0 to 132. A higher score indicates more severe physical symptoms.

    Measured: Baseline, Post-intervention at approximately 3 months

  4. Change from Baseline to Post-intervention in self-reported overstimulation

    Measured by the Multi-Modal Evaluation of Sensory Sensitivity (MESSY). It has 30 items assessed on a five-point Likert scale (1-5) with a total score of 30 to 150. There are seven subscales Multisensory Sensitivity (7 items), Visual Sensitivity (5 items), Auditory Sensitivity (5 items), Tactile Sensitivity (3 items), Chemosensory Sensitivity (4 items), Sensitivity to environmental temperature (3 items), and Motion Sensitivity (3 items). Mean subscale scores range from 1 and 5. Higher scores indicate more overstimulation symptoms.

    The three secondary outcomes listed above, in addition to this one, can be categorized into outcomes pertaining to mental and physical health as well as well-being.

    Measured: Baseline, Post-intervention at approximately 3 months

  5. Change from Baseline to Post-intervention in self-reported mindfulness

    Measured by the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF). It has 24 items assessed on a five-point Likert scale (1-5) with a total score ranging from 24 to 120. There are five subscales: Observing (4 items), Describing (5 items), Acting with awareness (5 items), Non-judging (5 items), and Nonreactivity (5 items) with subscale scores ranging from 4 to 20 for Observing and from 5 to 25 for the others. Higher scores indicate more mindfulness.

    Measured: Baseline, Post-intervention at approximately 3 months

  6. Change from Baseline to Post-intervention in self-reported attention regulation

    Measured by the Attention Control Scale (ACS). It has 20 items assessed on a four-point Likert scale (1-4) with a total score ranging from 20 to 80. There are two subscales: Attention Focusing (9 items) with a subscale score ranging from 9 to 36 and Attention Shifting (11 items) with a subscale score ranging from 11 to 44. Higher scores indicate more attention regulation.

    Measured: Baseline, Post-intervention at approximately 3 months

  7. Change from Baseline to Post-intervention in self-reported strategies for cognitive emotion regulation

    Measured by the Cognitive Emotion Regulation Questionnaire - Short Form (CERQ-SF). It has 18 items assessed on a five-point Likert scale (1-5). This study uses eight of in total nine subscales (and 16 items) with two items each: four adaptive strategy subscales: (Putting into perspective, Positive reappraisal, Positive refocusing, and Refocus on planning), and four less adaptive strategies (Self-blame, Other-blame, Rumination, and Catastrophizing). Subscale scores range from 2 to 10 and higher scores indicate more of that emotion regulation strategy.

    Measured: Baseline, Post-intervention at approximately 3 months

  8. Change from Baseline to Post-intervention in self-reported body awareness

    Measured by the Multidimensional Assessment of Interoceptive Awareness - 2 (MAIA-2). It has 37 items assessed on a six-point Likert scale (0-5). There are eight subscales: Noticing (4 items), Not Distracting (6 items), Not-Worrying (5 items), Attention Regulation (7 items), Emotional Awareness (5 items), Self-Regulation (4 items), Body Listening (3 items), and Trusting (3 items) with mean subscale scores ranging from 0 to 5. Higher scores indicate more of that body awareness aspect.

    Measured: Baseline, Post-intervention at approximately 3 months

  9. Change from Baseline to Post-intervention in self-reported self-compassion

    Measured by the Self-Compassion Scale - Short-Form (SCS-SF). It has 12 items assessed on seven-point Likert scale (1-7) with a total score ranging from 12 to 84. There are six subscales: Self-Kindness, Self-Judgement, Common Humanity, Isolation, Mindfulness, and Over-Identified with two items each. Subscale scores range from 2 and 14. Higher scores indicate more self-compassion.

    The four secondary outcomes listed above, in addition to this one, can be categorized into outcomes pertaining to potential mindfulness mechanisms.

    Measured: Baseline, Post-intervention at approximately 3 months

  10. Change from Baseline to Post-intervention in self-reported sensory processing sensitivity

    Measured by the Sensory Processing Sensitivity Questionnaire - Short Form (SPSQ-SF). It has 26 items assessed on a seven-point Likert scale (1-7) with a total score ranging from 26 to 182. There are six subscales: Sensory sensitivity to subtle internal and external stimuli (4 items), Social affective sensitivity (5 items), Aesthetic sensitivity (3 items), Sensory comfort (5 items), Sensory discomfort (4 items), and Emotional and physiological reactivity (5 items). The first four subscales make up the positive dimension and the last two subscales the negative dimension. Subscale scores and dimension scores are derived by adding up the relevant items. Higher scores indicate more sensory processing sensitivity aspects.

    Measured: Baseline, Post-intervention at approximately 3 months

  11. Perceived facilitators, barriers, effects, and mechanisms of participating in the MBSR training

    Semi-structured interview, participant observer

    Measured: Post-intervention at approximately 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start15 Jan 2024
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06390020
Sponsor's protocol ID
NL84880.091.23
Acronym
MindSens
Status last verified
Mar 2024
First submitted
20 Mar 2024
Last updated
29 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30639671

Questions about this trial

What is this clinical trial studying?

A study testing MBSR in people with Sensory Processing Sensitivity, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline to Post-intervention in self-reported depression, anxiety, and stress (time frame: Baseline, Post-intervention at approximately 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06390020, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.

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