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

NCT05568030 | Completed DMC

• 1 other identifier: CER-VD 2022-01316
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness; Fibromyalgia; Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Heart rate variability

  Within 3 hours

• Respiration rate

  Within 3 hours

• Oxygen saturation

  Within 3 hours

• Electrodermal activity

  Within 3 hours

• Cerebral activity

  Within 3 hours

Study Arms (2)

Mindfulness

EXPERIMENTAL

Behavioral: Mindfulness

Psycho-education

ACTIVE COMPARATOR

Behavioral: Psycho-education

Interventions

Mindfulness BEHAVIORAL

One session of a 20 minute mindfulness recording, based on standardised script, focused on stress management.

Mindfulness

Psycho-education BEHAVIORAL

One session of a 20 minute recording, based on standardised script, focused on psychophysiological stress response description.

Psycho-education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Centre de Médecine Intégrative et Complémentaire, CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Chantal Berna, Prof

  Centre de médecine intégrative et complémentaire, CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: October 5, 2022
• Study Start: October 28, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CH (1)