Mindfulness in Preparation to Bariatric Surgery

Study Overview
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Brief Summary
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Mindfulness is a common practice already widely used, that has shown benefits in terms of psychological and physical health. It is about learning or learn again to be self present and aware to the environment, across breathing, sensations, emotions and thought centering exercises, in the present moment without any judgement. The goal is to evaluate the efficacy of mindfulness versus an active control group in bariatric surgery.

Official Title
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Psycho-sensorial Mindfulness and Top-down Control : Mindfulness Program for Obese Patients in Preparation to Bariatric Surgery

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Bariatric surgery
* Procedure: Bariatric surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients: over 18 years Patients suffering from morbid obesity (BMI ≥ 40 kg/m²), or severe obesity (BMI ≥ 35 kg/m²) associate with at least a comorbidity likely to be improved by surgery Patient revised in second-line after the failure of a well conducted medical treatment, nutritional, dietetic and psychotherapeutic during 6 to 12 months : absence of enough weight loss or absence of maintain of weight loss Absence of any psychiatric counter-argument Exclusion Criteria: Subjects responding to inclusion criteria of the French National Authority for Health Subjects without agoraphobia, or obsessive-compulsive disorder, in post-traumatic stress disorder, alcohol or drugs dependant, without psychotic disorders, major depressive disorder, or suffering from anti-social personality disorder Patient registered for social security Free, signed and informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery<br>Obese patient without mindfulness program in parallel. | Procedure: Bariatric surgery<br>* With mindfulness programm<br>Procedure: Bariatric surgery<br>* Without mindfulness programm<br>|
| Active Comparator: Surgery with mindfulness program<br>Obese patient following a mindfulness program in parallel. | Procedure: Bariatric surgery<br>* With mindfulness programm<br>Procedure: Bariatric surgery<br>* Without mindfulness programm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric evaluation | Tool : SBC-20 - Scale of Body Connexion | About 15 minutes | 
| Psychometric evaluation | Tool : TAS-20 - The twenty-item Toronto Alexithymia Scale | About 15 minutes | 
| Psychometric evaluation | Tool : BAQ-18- Body Awareness Questionnaire | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, Mindfulness, Obese