Clinical trial NCT05568030: Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm
Official title: Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Fibromyalgia
Stress
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Perceived stress reactivity
timeFrame: Within 3 hours
Secondary outcomes:
measure: Heart rate variability
timeFrame: Within 3 hours
measure: Respiration rate
timeFrame: Within 3 hours
measure: Oxygen saturation
timeFrame: Within 3 hours
measure: Electrodermal activity
timeFrame: Within 3 hours
measure: Cerebral activity
timeFrame: Within 3 hours
measure: Salivary cortisol concentrations
timeFrame: Within 3 hours
measure: Blood catecholamine levels
timeFrame: Within 3 hours
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre de Médecine Intégrative et Complémentaire, CHUV
state: Vaud
Study officials:
affiliation: Centre de médecine intégrative et complémentaire, CHUV
name: Chantal Berna, Prof
role: PRINCIPAL_INVESTIGATOR
References: