Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm (SBST_FMS)

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 Overview

• Status: Completed
• Conditions: Stress; Fibromyalgia; Mindfulness
• Intervention / Treatment: Behavioral: Mindfulness; Behavioral: Psycho-education

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre de Médecine Intégrative et Complémentaire, CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness	Behavioral: Mindfulness; One session of a 20 minute mindfulness recording, based on standardised script, focused on stress management.
Active Comparator: Psycho-education	Behavioral: Psycho-education; One session of a 20 minute recording, based on standardised script, focused on psychophysiological stress response description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Within 3 hours
Cerebral activity	Cerebral activity will also be measured using a 6-electrodes headband electroencephalogram (Dreem headband, Dreem SAS).	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.	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.	Within 3 hours

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Principal Investigator: Chantal Berna, Prof, Centre de Médecine Intégrative et Complémentaire, CHUV

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia
• Other Study ID Numbers: CER-VD 2022-01316

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No