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

Last updated: March 3, 2025
Sponsor: University of Lausanne Hospitals
Overall Status: Completed

Phase

N/A

Condition

Fibromyalgia

Stress

Treatment

Mindfulness

Psycho-education

Clinical Study ID

NCT05568030
CER-VD 2022-01316
  • Ages > 18
  • Female

Study 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

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 informedconsent. Specifically, patients must fulfil the criteria of the American College ofRheumatology (2010) by having the following combination of scores at the widespreadpain 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

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 3month under the same dose).

  • Somatic co-morbidity that could interfere with physiological monitoring/stresstolerance: such as cardiac malformation, recent myocardial dysfunction, cardiactransplantation, or cardiac treatment (pacemaker, antiarrhythmic drugs, muscarinicreceptor 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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Mindfulness
Phase:
Study Start date:
October 28, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Centre de Médecine Intégrative et Complémentaire, CHUV

    Lausanne, Vaud 1011
    Switzerland

    Site Not Available

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