MindfulnessSBST_FMSNCT05568030
Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm
A study testing Mindfulness and Psycho-education in people with Mindfulness and Fibromyalgia, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
This study is a double-blinded randomized controlled trial with two arms, comparing a recorded mindfulness intervention to a control psycho-education audio. It is a monocentric study that will take place in Centre Hospitalier Universitaire Vaudois (CHUV), a primary teaching hospital in Lausanne, Switzerland. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mindfulness, Fibromyalgia, Stress
- What is being tested?
- Mindfulness and Psycho-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Oct 2022to 31 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We plan to recruit adult female patients (>18 years old) suffering from fibromyalgia (FMS), with chronic pain (more than 6 months), willing and able to give informed consent. Specifically, patients must fulfil the criteria of the American College of Rheumatology (2010) by having the following combination of scores at the widespread pain index (WPI) and the severity score (SS) :
- WPI score is ≥7 and the SS score is ≥ 5 OR
- WPI score is comprised between 3 to 6 and the SS score ≥9
- And no other condition explaining the painful syndrome
Who cannot join
- Insufficient French language skills
- Unstable psychiatric co-morbidity: major depression with current suicidal risk, unstable psychotic disorder, unstable psychotropic medication (stable=more than 3 month under the same dose).
- Somatic co-morbidity that could interfere with physiological monitoring/stress tolerance: such as cardiac malformation, recent myocardial dysfunction, cardiac transplantation, or cardiac treatment (pacemaker, antiarrhythmic drugs, muscarinic receptor blockers, ACE inhibitors or any that would induce a modification in HR)
- Contraindication to sensors positioning (local skin damage or allergies)
- Substance use disorder (alcohol, drugs).
- Refusal to listen to an audio recording of mindfulness
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre de Médecine Intégrative et Complémentaire, CHUV
Lausanne, Canton of Vaud, 1011
About this study
This study is a double-blinded randomized controlled trial with two arms, comparing a recorded mindfulness intervention to a control psycho-education audio. It is a monocentric study that will take place in Centre Hospitalier Universitaire Vaudois (CHUV), a primary teaching hospital in Lausanne, Switzerland.
Patients will be randomized 1:1 to the brief mindfulness intervention vs neutral audio intervention. The investigators involved in recruitment and testing will be blind to the intervention condition. A collaborator that is not involved in this study will prepare a coded randomized sequence of audio assignments, uploaded in Redcap. The audio will be played on a laptop or mp-player with a noise cancelling headset.
- Conditions
- Mindfulness, Fibromyalgia, Stress
- Being tested
- Mindfulness, Psycho-education
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
One session of a 20 minute mindfulness recording, based on standardised script, focused on stress management.
Psycho-educationBehavioural
One session of a 20 minute recording, based on standardised script, focused on psychophysiological stress response description.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Not described Receives: Behavioral: Mindfulness |
| Psycho-education | Active comparator | Not described Receives: Behavioral: Psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress reactivity
The primary outcome is the variation of perceived stress level along the task. A 2-way repeated-measures ANOVA will be conducted to compare the stress reactivity of patients receiving the mindfulness intervention and the control intervention.
Perceived stress will be measured using visual analog scales from 0 to 10, 0 meaning no stress perceived and 10 meaning the highest stress perceived.
Measured: Within 3 hours
Secondary outcomes (7)
Heart rate variability
Heart rate variability will also be measured using a NeXus-10 MKII, Mindmedia with 3 electrodes.
A 2-way repeated-measures ANOVA will be conducted to compare the heart rate variability of patients receiving the mindfulness intervention and the control intervention.
Measured: Within 3 hours
Respiration rate
Respiration rate will also be measured using a NeXus-10 MKII, Mindmedia with a thoracic belt.
A 2-way repeated-measures ANOVA will be conducted to compare the respiration rate of patients receiving the mindfulness intervention and the control intervention.
Measured: Within 3 hours
Oxygen saturation
Oxygen saturation will also be measured using a NeXus-10 MKII, Mindmedia with a pulse oximeter probe.
A 2-way repeated-measures ANOVA will be conducted to compare the oxygen saturation of patients receiving the mindfulness intervention and the control intervention.
Measured: Within 3 hours
Electrodermal activity
Electrodermal activity will also be measured using a NeXus-10 MKII, Mindmedia with two fingertips electrodes.
A 2-way repeated-measures ANOVA will be conducted to compare the electrodermal activity of patients receiving the mindfulness intervention and the control intervention.
Measured: Within 3 hours
Cerebral activity
Cerebral activity will also be measured using a 6-electrodes headband electroencephalogram (Dreem headband, Dreem SAS).
Measured: Within 3 hours
Salivary cortisol concentrations
Salivary cortisol concentration will also be collected using a mouth cotton swab. A 2-way repeated-measures ANOVA will be conducted to compare the salivary cortisol concentrations of patients receiving the mindfulness intervention and the control intervention.
Measured: Within 3 hours
Blood catecholamine levels
Blood catecholamine levels will also be collected using a venous line on the non-dominant arm for repeated blood collection. A 2-way repeated-measures ANOVA will be conducted to compare the blood catecholamine levels of patients receiving the mindfulness intervention and the control intervention.
Measured: Within 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start28 Oct 2022
- Primary completion20 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chantal Berna, University of Lausanne Hospitals
- Investigators
- Chantal Berna, Prof, Principal investigator, Centre de médecine intégrative et complémentaire, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568030
- Sponsor's protocol ID
- CER-VD 2022-01316
- Acronym
- SBST_FMS
- Status last verified
- Mar 2025
- First submitted
- 1 Sep 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm
- ClinicalTrials.gov ID
- NCT05568030
- Acronym / sponsor ID
- SBST_FMS / CER-VD 2022-01316
- Conditions
- Mindfulness, Fibromyalgia, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Oct 2022 (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 is a double-blinded randomized controlled trial with two arms, comparing a recorded mindfulness intervention to a control psycho-education audio. It is a monocentric study that will take place in Centre Hospitalier Universitaire Vaudois (CHUV), a primary teaching hospital in Lausanne, Switzerland.
Patients will be randomized 1:1 to the brief mindfulness intervention vs neutral audio intervention. The investigators involved in recruitment and testing will be blind to the intervention condition. A collaborator that is not involved in this study will prepare a coded randomized sequence of audio assignments, uploaded in Redcap. The audio will be played on a laptop or mp-player with a noise cancelling headset.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness |
| Psycho-education | Active comparator | Behavioral: Psycho-education |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- We plan to recruit adult female patients (>18 years old) suffering from fibromyalgia (FMS), with chronic pain (more than 6 months), willing and able to give informed consent. Specifically, patients must fulfil the criteria of the American College of Rheumatology (2010) by having the following combination of scores at the widespread pain index (WPI) and the severity score (SS) :
- WPI score is ≥7 and the SS score is ≥ 5 OR
- WPI score is comprised between 3 to 6 and the SS score ≥9
- And no other condition explaining the painful syndrome
Key exclusion criteria (6 listed)
- Insufficient French language skills
- Unstable psychiatric co-morbidity: major depression with current suicidal risk, unstable psychotic disorder, unstable psychotropic medication (stable=more than 3 month under the same dose).
- Somatic co-morbidity that could interfere with physiological monitoring/stress tolerance: such as cardiac malformation, recent myocardial dysfunction, cardiac transplantation, or cardiac treatment (pacemaker, antiarrhythmic drugs, muscarinic receptor blockers, ACE inhibitors or any that would induce a modification in HR)
- Contraindication to sensors positioning (local skin damage or allergies)
- Substance use disorder (alcohol, drugs).
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 |
|---|---|---|
| MindfulnessOne session of a 20 minute mindfulness recording, based on standardised script, focused on stress management. | Behavioural | Mindfulness |
| Psycho-educationOne session of a 20 minute recording, based on standardised script, focused on psychophysiological stress response description. | Behavioural | Psycho-education |
Primary outcome
Perceived stress reactivity
Time frame: Within 3 hours
The primary outcome is the variation of perceived stress level along the task. A 2-way repeated-measures ANOVA will be conducted to compare the stress reactivity of patients receiving the mindfulness intervention and the control intervention. Perceived stress will be measured using visual analog scales from 0 to 10, 0 meaning no stress perceived and 10 meaning the highest stress perceived.
7 secondary outcomes
Heart rate variability
Time frame: Within 3 hours
Respiration rate
Time frame: Within 3 hours
Oxygen saturation
Time frame: Within 3 hours
Electrodermal activity
Time frame: Within 3 hours
Cerebral activity
Time frame: Within 3 hours
Salivary cortisol concentrations
Time frame: Within 3 hours
Blood catecholamine levels
Time frame: Within 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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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.
Chantal Berna, Prof principal investigator
Centre de médecine intégrative et complémentaire, CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Psycho-education in people with Mindfulness and Fibromyalgia, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 6 Mar 2025. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress reactivity (time frame: Within 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.