NCT05568030

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-10-28
• Primary completion: 2024-12-20
• Completion: 2024-12-31
• First posted: 2022-10-05
• Last updated: 2025-03-06

Locations

1 site across 1 country: Switzerland