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

Lausanne University Hospital (CHUV)

Status

Completed

Conditions

Fibromyalgia

Mindfulness

Stress

Treatments

Behavioral: Mindfulness

Behavioral: Psycho-education

Study type

Interventional

Funder types

Other

Identifiers

NCT05568030

CER-VD 2022-01316

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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