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
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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