Mindfulness in Preparation to Bariatric Surgery

Obesity Clinical Trial

— PConscience  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854306
• Other study ID #: 38RC12.215
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: December 22, 2017
• Start date: March 2013
• Est. completion date: November 14, 2014

Study information

• Verified date: December 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 14, 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Bariatric surgery
With mindfulness programm
• Bariatric surgery
Without mindfulness programm

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (20)

Breslin KT, Reed MR, Malone SB. An holistic approach to substance abuse treatment. J Psychoactive Drugs. 2003 Apr-Jun;35(2):247-51. Review. — View Citation

Cserjési R, Luminet O, Poncelet AS, Lénárd L. Altered executive function in obesity. Exploration of the role of affective states on cognitive abilities. Appetite. 2009 Apr;52(2):535-9. — View Citation

Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. — View Citation

Heatherton TF, Baumeister RF. Binge eating as escape from self-awareness. Psychol Bull. 1991 Jul;110(1):86-108. Review. — View Citation

Jon-Kabat-Zinn. (2009) Au cœur de la tourmente, la pleine conscience : MBSR, la réduction du stress basée sur la mindfulness, Bruxelles, De Boeck, coll. Carrefour des Psychothérapies

Karason K, Mølgaard H, Wikstrand J, Sjöström L. Heart rate variability in obesity and the effect of weight loss. Am J Cardiol. 1999 Apr 15;83(8):1242-7. — View Citation

Keng SL, Smoski MJ, Robins CJ. Effects of mindfulness on psychological health: a review of empirical studies. Clin Psychol Rev. 2011 Aug;31(6):1041-56. doi: 10.1016/j.cpr.2011.04.006. Epub 2011 May 13. Review. — View Citation

Leahey T.M., Crowther J. H., Irwin S.R. (2008) A cognitive-behavioral mindfulness group therapy intervention for the treatment of binge eating in bariatric surgery patients. Cognitive and Behavioral Practice, 15(4), p.364-375.

Lutz A, McFarlin DR, Perlman DM, Salomons TV, Davidson RJ. Altered anterior insula activation during anticipation and experience of painful stimuli in expert meditators. Neuroimage. 2013 Jan 1;64:538-46. doi: 10.1016/j.neuroimage.2012.09.030. Epub 2012 Sep 19. — View Citation

Lutz A, Slagter HA, Dunne JD, Davidson RJ. Attention regulation and monitoring in meditation. Trends Cogn Sci. 2008 Apr;12(4):163-9. doi: 10.1016/j.tics.2008.01.005. Epub 2008 Mar 10. Review. — View Citation

Mobbs O, Crépin C, Thiéry C, Golay A, Van der Linden M. Obesity and the four facets of impulsivity. Patient Educ Couns. 2010 Jun;79(3):372-7. doi: 10.1016/j.pec.2010.03.003. Epub 2010 Apr 18. — View Citation

Moeller FG, Barratt ES, Dougherty DM, Schmitz JM, Swann AC. Psychiatric aspects of impulsivity. Am J Psychiatry. 2001 Nov;158(11):1783-93. Review. — View Citation

Nederkoorn C, Smulders FT, Havermans RC, Roefs A, Jansen A. Impulsivity in obese women. Appetite. 2006 Sep;47(2):253-6. Epub 2006 Jun 19. — View Citation

Praissman S. Mindfulness-based stress reduction: a literature review and clinician's guide. J Am Acad Nurse Pract. 2008 Apr;20(4):212-6. doi: 10.1111/j.1745-7599.2008.00306.x. Review. — View Citation

Price CJ, Wells EA, Donovan DM, Rue T. Mindful awareness in body-oriented therapy as an adjunct to women's substance use disorder treatment: a pilot feasibility study. J Subst Abuse Treat. 2012 Jul;43(1):94-107. doi: 10.1016/j.jsat.2011.09.016. Epub 2011 Nov 25. — View Citation

Taylor GJ. Alexithymia: concept, measurement, and implications for treatment. Am J Psychiatry. 1984 Jun;141(6):725-32. Review. — View Citation

Van Strien T, Engels RC, Van Leeuwe J, Snoek HM. The Stice model of overeating: tests in clinical and non-clinical samples. Appetite. 2005 Dec;45(3):205-13. Epub 2005 Oct 20. — View Citation

Waller G, Babbs M, Wright F, Potterton C, Meyer C, Leung N. Somatoform dissociation in eating-disordered patients. Behav Res Ther. 2003 May;41(5):619-27. — View Citation

Weineland S, Arvidsson D, Kakoulidis TP, Dahl J. Acceptance and commitment therapy for bariatric surgery patients, a pilot RCT. Obes Res Clin Pract. 2012 Jan-Mar;6(1):e1-e90. doi: 10.1016/j.orcp.2011.04.004. — View Citation

Wiser S, Telch CF. Dialectical behavior therapy for Binge-Eating Disorder. J Clin Psychol. 1999 Jun;55(6):755-68. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychometric evaluation	Tool : SBC-20 - Scale of Body Connexion	About 15 minutes
Primary	Psychometric evaluation	Tool : TAS-20 - The twenty-item Toronto Alexithymia Scale	About 15 minutes
Primary	Psychometric evaluation	Tool : BAQ-18- Body Awareness Questionnaire	15 minutes