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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm

Conditions
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Mindfulness, Fibromyalgia, Stress

Intervention / Treatment
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* Behavioral: Mindfulness
* Behavioral: Psycho-education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |