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

NCT05568030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-06

No results posted yet for this 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.

Conditions

  • Mindfulness
  • Fibromyalgia
  • Stress

Interventions

BEHAVIORAL

Mindfulness

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

BEHAVIORAL

Psycho-education

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

Sponsors & Collaborators

  • University of Lausanne Hospitals

    lead OTHER

Principal Investigators

  • Chantal Berna, Prof · Centre de médecine intégrative et complémentaire, CHUV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2024-12-20
Completion
2024-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05568030 on ClinicalTrials.gov