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

University of Lausanne Hospitals60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Mindfulness Fibromyalgia Stress

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Within 3 hours

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Within 3 hours

Cerebral activity

Cerebral activity will also be measured using a 6-electrodes headband electroencephalogram (Dreem headband, Dreem SAS).

Time frame: 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.

Time frame: 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.

Time frame: Within 3 hours

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes