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

NCT ID: NCT05568030

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness

Group Type: EXPERIMENTAL

Mindfulness

Intervention Type: BEHAVIORAL

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

Psycho-education

Group Type: ACTIVE_COMPARATOR

Psycho-education

Intervention Type: BEHAVIORAL

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

Interventions

Mindfulness

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

Intervention Type: BEHAVIORAL

Psycho-education

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Chantal Berna

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chantal Berna, Prof

Role: PRINCIPAL_INVESTIGATOR

Centre de médecine intégrative et complémentaire, CHUV

Locations

Centre de Médecine Intégrative et Complémentaire, CHUV

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

CER-VD 2022-01316

Identifier Type: -

Identifier Source: org_study_id