Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2013-03-31
2014-11-14
Brief Summary
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The goal is to evaluate the efficacy of "mindfulness" versus an active control group in bariatric surgery.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Surgery
Obese patient without mindfulness program in parallel.
Bariatric surgery
With mindfulness programm
Bariatric surgery
Without mindfulness programm
Surgery with mindfulness program
Obese patient following a mindfulness program in parallel.
Bariatric surgery
With mindfulness programm
Bariatric surgery
Without mindfulness programm
Interventions
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Bariatric surgery
With mindfulness programm
Bariatric surgery
Without mindfulness programm
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Pierre Yves Benhamou, Professor
Role: PRINCIPAL_INVESTIGATOR
Grenoble Hospital University
Locations
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UniversityHospitalGrenoble
La Tronche, , France
Countries
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References
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Breslin KT, Reed MR, Malone SB. An holistic approach to substance abuse treatment. J Psychoactive Drugs. 2003 Apr-Jun;35(2):247-51. doi: 10.1080/02791072.2003.10400006.
Cserjesi R, Luminet O, Poncelet AS, Lenard L. Altered executive function in obesity. Exploration of the role of affective states on cognitive abilities. Appetite. 2009 Apr;52(2):535-9. doi: 10.1016/j.appet.2009.01.003.
Heatherton TF, Baumeister RF. Binge eating as escape from self-awareness. Psychol Bull. 1991 Jul;110(1):86-108. doi: 10.1037/0033-2909.110.1.86.
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
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. doi: 10.1016/S0022-3999(03)00573-7.
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.
Karason K, Molgaard H, Wikstrand J, Sjostrom L. Heart rate variability in obesity and the effect of weight loss. Am J Cardiol. 1999 Apr 15;83(8):1242-7. doi: 10.1016/s0002-9149(99)00066-1.
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.
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.
Mobbs O, Crepin C, Thiery 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.
Moeller FG, Barratt ES, Dougherty DM, Schmitz JM, Swann AC. Psychiatric aspects of impulsivity. Am J Psychiatry. 2001 Nov;158(11):1783-93. doi: 10.1176/appi.ajp.158.11.1783.
Nederkoorn C, Smulders FT, Havermans RC, Roefs A, Jansen A. Impulsivity in obese women. Appetite. 2006 Sep;47(2):253-6. doi: 10.1016/j.appet.2006.05.008. Epub 2006 Jun 19.
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.
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.
Taylor GJ. Alexithymia: concept, measurement, and implications for treatment. Am J Psychiatry. 1984 Jun;141(6):725-32. doi: 10.1176/ajp.141.6.725.
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. doi: 10.1016/j.appet.2005.08.004. Epub 2005 Oct 20.
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. doi: 10.1016/s0005-7967(03)00019-6.
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.
Wiser S, Telch CF. Dialectical behavior therapy for Binge-Eating Disorder. J Clin Psychol. 1999 Jun;55(6):755-68. doi: 10.1002/(sici)1097-4679(199906)55:63.0.co;2-r.
Other Identifiers
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38RC12.215
Identifier Type: -
Identifier Source: org_study_id