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

Not Applicable

Completed

• Conditions: Fibromyalgia; Mindfulness; Stress
• Interventions: Behavioral: Mindfulness; Behavioral: Psycho-education

• Registration Number: NCT05568030
• Lead Sponsor: University of Lausanne Hospitals

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-05
• Study Start: 2022-10-28
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness	Mindfulness	-
Psycho-education	Psycho-education	-

Primary Outcome Measures

Name	Time	Method
Perceived stress reactivity	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.

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation	Within 3 hours	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.
Heart rate variability	Within 3 hours	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.
Electrodermal activity	Within 3 hours	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.
Blood catecholamine levels	Within 3 hours	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.
Respiration rate	Within 3 hours	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.
Cerebral activity	Within 3 hours	Cerebral activity will also be measured using a 6-electrodes headband electroencephalogram (Dreem headband, Dreem SAS).
Salivary cortisol concentrations	Within 3 hours	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.

Trial Locations

Locations (1)

Centre de Médecine Intégrative et Complémentaire, CHUV; 🇨🇭 Lausanne, Vaud, Switzerland