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.
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
- Recruiting
The Radboudumc Center for Mindfulness
Nijmegen, Gelderland, 6525 GC
Anne Speckens, prof. dr., (024) 36 68 456, mindfulness@radboudumc.nl
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.
- Conditions
- Sensory Processing Sensitivity
- 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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants instructed not to partake in any (similar) mindfulness or meditation training. |
| MBSR training | Experimental | Not described Receives: Other: MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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.
- First posted29 Apr 2024
- Study start15 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensory Processing SensitivityStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Speckens, prof. dr., Principal investigator, Radboudumc, Centre for MindfulnessCorina Greven, prof. dr., Principal investigator, Donders Centre for Cognitive Neuroimaging
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Stress Reduction for People High on the Personality Trait Sensory Processing Sensitivity: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT06390020
- Acronym / sponsor ID
- MindSens / NL84880.091.23
- Conditions
- Sensory Processing Sensitivity
- Keywords
- Sensory processing sensitivity, Highly sensitive person, Mindfulness-based stress reduction, Mindfulness, Depression, Anxiety, Stress, Self-regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants instructed not to partake in any (similar) mindfulness or meditation training. |
| MBSR training | Experimental | Other: MBSR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSRThe 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. | Other | MBSR training |
Primary outcome
Change from Baseline to Post-intervention in self-reported depression, anxiety, and stress
Time frame: Baseline, Post-intervention at approximately 3 months
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.
11 secondary outcomes
Change from Baseline to Post-intervention in self-reported well-being
Time frame: Baseline, Post-intervention at approximately 3 months
Change from Baseline to Post-intervention in self-reported burnout symptoms
Time frame: Baseline, Post-intervention at approximately 3 months
Change from Baseline to Post-intervention in self-reported physical symptoms
Time frame: Baseline, Post-intervention at approximately 3 months
Change from Baseline to Post-intervention in self-reported overstimulation
Time frame: Baseline, Post-intervention at approximately 3 months
Change from Baseline to Post-intervention in self-reported mindfulness
Time frame: Baseline, Post-intervention at approximately 3 months
Change from Baseline to Post-intervention in self-reported attention regulation
Time frame: Baseline, Post-intervention at approximately 3 months
Change from Baseline to Post-intervention in self-reported strategies for cognitive emotion regulation
Time frame: Baseline, Post-intervention at approximately 3 months
Change from Baseline to Post-intervention in self-reported body awareness
Time frame: Baseline, Post-intervention at approximately 3 months
Change from Baseline to Post-intervention in self-reported self-compassion
Time frame: Baseline, Post-intervention at approximately 3 months
Change from Baseline to Post-intervention in self-reported sensory processing sensitivity
Time frame: Baseline, Post-intervention at approximately 3 months
Perceived facilitators, barriers, effects, and mechanisms of participating in the MBSR training
Time frame: Post-intervention at approximately 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Background: PubMed 30639671Greven 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Speckens, prof. dr. principal investigator
Radboudumc, Centre for Mindfulness
Corina Greven, prof. dr. principal investigator
Donders Centre for Cognitive Neuroimaging
1 site in 1 country: see every site and its status.
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.