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

Stress Clinical Trial

— SBST_FMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05568030
• Other study ID #: CER-VD 2022-01316
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2023
• Source: University of Lausanne Hospitals
• Contact: Chantal Berna, Prof
• Phone: +41213142040
• Email: chantal.berna-renella[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Mindfulness
• Stress

Intervention

Behavioral:
• Mindfulness
One session of a 20 minute mindfulness recording, based on standardised script, focused on stress management.
• Psycho-education
One session of a 20 minute recording, based on standardised script, focused on psychophysiological stress response description.

Locations

Country	Name	City	State
Switzerland	Centre de Médecine Intégrative et Complémentaire, CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cerebral activity	Cerebral activity will also be measured using a 6-electrodes headband electroencephalogram (Dreem headband, Dreem SAS).	Within 3 hours
Secondary	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
Secondary	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