The STRATOB study: design of a randomized controlled clinical trial of Cognitive Behavioral Therapy and Brief Strategic Therapy with telecare in patients with obesity and binge-eating disorder referred to residential nutritional rehabilitation

Gianluca Castelnuovo, Gian Mauro Manzoni, Valentina Villa, Gian Luca Cesa, Giada Pietrabissa, Enrico Molinari, Gianluca Castelnuovo, Gian Mauro Manzoni, Valentina Villa, Gian Luca Cesa, Giada Pietrabissa, Enrico Molinari

Abstract

Background: Overweight and obesity are linked with binge eating disorder (BED). Effective interventions to significantly reduce weight, maintain weight loss and manage associated pathologies like BED are typically combined treatment options (dietetic, nutritional, physical, behavioral, cognitive-behavioral, pharmacological, surgical). Significant difficulties with regard to availability, costs, treatment adherence and long-term efficacy are present. Particularly Cognitive Behavioral Therapy (CBT) is the therapeutic approach indicated both in in-patient and in out-patient settings for BED. In recent years systemic and systemic-strategic psychotherapies have been implemented to treat patients with obesity and BED involved in familiar problems. Particularly a brief protocol for the systemic-strategic treatment of BED, using overall the strategic dialogue, has been recently developed. Moreover telemedicine, a new promising low cost method, has been used for obesity with BED in out-patient settings in order to avoid relapse after the in-patient step of treatment and to keep on a continuity of care with the involvement of the same clinical in-patient team.

Methods: The comparison between CBT and Brief Strategic Therapy (BST) will be assessed in a two-arm randomized controlled clinical trial. Due to the novelty of the application of BST in BED treatment (no other RCTs including BST have been carried out), a pilot study will be carried out before conducting a large scale randomized controlled clinical trial (RCT). Both CBT and BST group will follow an in-hospital treatment (diet, physical activity, dietitian counseling, 8 psychological sessions) plus 8 out-patient telephone-based sessions of psychological support and monitoring with the same in-patient psychotherapists. Primary outcome measure of the randomized trial will be the change in the Global Index of the Outcome Questionnaire (OQ-45.2). Secondary outcome measures will be the percentage of BED patients remitted considering the number of weekly binge episodes and the weight loss. Data will be collected at baseline, at discharge from the hospital (c.a. 1 month after) and after 6-12-24 months from the end of the in-hospital treatment. Data at follow-up time points will be collected through tele-sessions.

Discussion: The STRATOB (Systemic and STRATegic psychotherapy for OBesity), a comprehensive two-phase stepped down program enhanced by telepsychology for the medium-term treatment of obese people with BED seeking intervention for weight loss, will shed light about the comparison of the effectiveness of the BST with the gold standard CBT and about the continuity of care at home using a low-level of telecare (mobile phones).

Trial registration: ClinicalTrials.gov Identifier: NCT01096251

References

    1. WHO. Definition and Diagnosis of Diabetes Mellitus and Intermediate Hyperglycemia. Report of a WHO/IDF consultation. 2006.
    1. Pi-Sunyer X. The medical risks of obesity. Postgrad Med. 2009;121:21–33. doi: 10.3810/pgm.2009.11.2074.
    1. Gnacinska M, Malgorzewicz S, Stojek M, Lysiak-Szydlowska W, Sworczak K. Role of adipokines in complications related to obesity: a review. Adv Med Sci. 2009;54:150–157. doi: 10.2478/v10039-009-0035-2.
    1. van Kruijsdijk RC, van der Wall E, Visseren FL. Obesity and cancer: the role of dysfunctional adipose tissue. Cancer Epidemiol Biomarkers Prev. 2009;18:2569–2578. doi: 10.1158/1055-9965.EPI-09-0372.
    1. McCallister JW, Adkins EJ, O'Brien JM Jr. Obesity and acute lung injury. Clin Chest Med. 2009;30:495–508. doi: 10.1016/j.ccm.2009.05.008. viii.
    1. Shah N, Roux F. The relationship of obesity and obstructive sleep apnea. Clin Chest Med. 2009;30:455–465. doi: 10.1016/j.ccm.2009.05.012. vii.
    1. Beleigoli AM, Diniz MF, Ribeiro AL. Natriuretic peptides: linking heart and adipose tissue in obesity and related conditions--a systematic review. Obes Rev. 2009;10:617–626. doi: 10.1111/j.1467-789X.2009.00624.x.
    1. Momeni A, Heier M, Bannasch H, Stark GB. Complications in abdominoplasty: a risk factor analysis. J Plast Reconstr Aesthet Surg. 2009;62:1250–1254. doi: 10.1016/j.bjps.2008.03.043.
    1. Wilson GT, Wilfley DE, Agras WS, Bryson SW. Psychological treatments of binge eating disorder. Arch Gen Psychiatry. pp. 94–101.
    1. Weinstein PK. A review of weight loss programs delivered via the Internet. J Cardiovasc Nurs. 2006;21:251–258. quiz 259-260.
    1. Hill JO, Thompson H, Wyatt H. Weight maintenance: what's missing? J Am Diet Assoc. 2005;105:S63–66.
    1. Wing RR, Tate DF, Gorin AA, Raynor HA, Fava JL. A self-regulation program for maintenance of weight loss. N Engl J Med. 2006;355:1563–1571. doi: 10.1056/NEJMoa061883.
    1. Jeffery RW, Drewnowski A, Epstein LH, Stunkard AJ, Wilson GT, Wing RR, Hill DR. Long-term maintenance of weight loss: current status. Health Psychol. 2000;19:5–16.
    1. Katan MB. Weight-loss diets for the prevention and treatment of obesity. N Engl J Med. 2009;360:923–925. doi: 10.1056/NEJMe0810291.
    1. Schlup B, Munsch S, Meyer AH, Margraf J, Wilhelm FH. The efficacy of a short version of a cognitive-behavioral treatment followed by booster sessions for binge eating disorder. Behav Res Ther. 2009;47:628–635. doi: 10.1016/j.brat.2009.04.003.
    1. Sarwer DB. Comment on: brief, four session group CBT reduces binge eating behaviors among bariatric surgery candidates (Ashton K, et al. 2009;5:257-62. Surg Obes Relat Dis. 2009;5:407–408. doi: 10.1016/j.soard.2009.02.006.
    1. Ashton K, Drerup M, Windover A, Heinberg L. Brief, four-session group CBT reduces binge eating behaviors among bariatric surgery candidates. Surg Obes Relat Dis. 2009;5:257–262. doi: 10.1016/j.soard.2009.01.005.
    1. Tsiros MD, Sinn N, Brennan L, Coates AM, Walkley JW, Petkov J, Howe PR, Buckley JD. Cognitive behavioral therapy improves diet and body composition in overweight and obese adolescents. Am J Clin Nutr. 2008;87:1134–1140.
    1. Munsch S, Roth B, Michael T, Meyer AH, Biedert E, Roth S, Speck V, Zumsteg U, Isler E, Margraf J. Randomized controlled comparison of two cognitive behavioral therapies for obese children: mother versus mother-child cognitive behavioral therapy. Psychother Psychosom. 2008;77:235–246. doi: 10.1159/000129659.
    1. Shelley-Ummenhofer J, MacMillan PD. Cognitive-behavioural treatment for women who binge eat. Can J Diet Pract Res. 2007;68:139–142. doi: 10.3148/68.3.2007.139.
    1. Eichler K, Zoller M, Steurer J, Bachmann LM. Cognitive-behavioural treatment for weight loss in primary care: a prospective study. Swiss Med Wkly. 2007;137:489–495.
    1. Brownley KA, Berkman ND, Sedway JA, Lohr KN, Bulik CM. Binge eating disorder treatment: a systematic review of randomized controlled trials. Int J Eat Disord. 2007;40:337–348. doi: 10.1002/eat.20370.
    1. Vaidya V. Cognitive behavior therapy of binge eating disorder. Adv Psychosom Med. 2006;27:86–93.
    1. Grilo CM, Masheb RM, Wilson GT. Rapid response to treatment for binge eating disorder. J Consult Clin Psychol. 2006;74:602–613.
    1. Fennig S. Can we treat morbid obese children in a behavioral inpatient program? Pediatr Endocrinol Rev. 2006;3 Suppl 4:590–596.
    1. Berkman ND, Bulik CM, Brownley KA, Lohr KN, Sedway JA, Rooks A, Gartlehner G. Management of eating disorders. Evid Rep Technol Assess (Full Rep) 2006. pp. 1–166.
    1. Wilson GT. Psychological treatment of eating disorders. Annu Rev Clin Psychol. 2005;1:439–465. doi: 10.1146/annurev.clinpsy.1.102803.144250.
    1. Peterson Y. Family therapy treatment: working with obese children and their families with small steps and realistic goals. Acta Paediatr Suppl. 2005;94:42–44. doi: 10.1080/08035320510035573.
    1. Molinari E, Baruffi M, Croci M, Marchi S, Petroni ML. Binge eating disorder in obesity: comparison of different therapeutic strategies. Eat Weight Disord. 2005;10:154–161.
    1. Wilfley DE, Cohen LR. Psychological treatment of bulimia nervosa and binge eating disorder. Psychopharmacol Bull. 1997;33:437–454.
    1. Nardone G, Portelli C. Knowing through changing: The Evolution of Brief Strategic Therapy. Crown House Publishing Limited; 2005.
    1. Milanese R. Advanced Brief therapy for eating disorders. Brief Strategic and Systemic Therapy European Review. 2004;1:125–129.
    1. Nardone G, Barbieri Brook R. Advanced Brief Strategic Therapy: An overview of interventions with eating disorders to exemplify how theory and practice work. European Journal of Psychotherapy & Counselling. 2010;12:113–127. doi: 10.1080/13642537.2010.482743.
    1. Marks S, Shaikh U, Hilty DM, Cole S. Weight status of children and adolescents in a telepsychiatry clinic. Telemed J E Health. 2009;15:970–974. doi: 10.1089/tmj.2008.0150.
    1. Shaikh U, Cole SL, Marcin JP, Nesbitt TS. Clinical management and patient outcomes among children and adolescents receiving telemedicine consultations for obesity. Telemed J E Health. 2008;14:434–440. doi: 10.1089/tmj.2007.0075.
    1. Riva G, Alcaniz M, Anolli L, Bacchetta M, Banos R, Beltrame F, Botella C, Galimberti C, Gamberini L, Gaggioli A. et al.The VEPSY UPDATED project: technical and clinical rationale. Stud Health Technol Inform. 2002;85:395–401.
    1. Riva G, Alcaniz M, Anolli L, Bacchetta M, Banos R, Beltrame F, Botella C, Galimberti C, Gamberini L, Gaggioli A. et al.The VEPSY updated project: virtual reality in clinical psychology. Cyberpsychol Behav. 2001;4:449–455. doi: 10.1089/109493101750527006.
    1. Tate DF, Jackvony EH, Wing RR. Effects of Internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. JAMA. 2003;289:1833–1836. doi: 10.1001/jama.289.14.1833.
    1. Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006;166:1620–1625. doi: 10.1001/archinte.166.15.1620.
    1. Tate DF, Wing RR, Winett RA. Using Internet technology to deliver a behavioral weight loss program. JAMA. 2001;285:1172–1177. doi: 10.1001/jama.285.9.1172.
    1. Harvey-Berino J, Pintauro S, Buzzell P, Gold EC. Effect of internet support on the long-term maintenance of weight loss. Obes Res. 2004;12:320–329. doi: 10.1038/oby.2004.40.
    1. Haugen HA, Tran ZV, Wyatt HR, Barry MJ, Hill JO. Using telehealth to increase participation in weight maintenance programs. Obesity (Silver Spring) 2007;15:3067–3077. doi: 10.1038/oby.2007.365.
    1. Shapiro JR, Bauer S, Hamer RM, Kordy H, Ward D, Bulik CM. Use of text messaging for monitoring sugar-sweetened beverages, physical activity, and screen time in children: a pilot study. J Nutr Educ Behav. 2008;40:385–391. doi: 10.1016/j.jneb.2007.09.014.
    1. McTigue KM, Conroy MB, Hess R, Bryce CL, Fiorillo AB, Fischer GS, Milas NC, Simkin-Silverman LR. Using the internet to translate an evidence-based lifestyle intervention into practice. Telemed J E Health. 2009;15:851–858. doi: 10.1089/tmj.2009.0036.
    1. Krukowski RA, Harvey-Berino J, Ashikaga T, Thomas CS, Micco N. Internet-based weight control: the relationship between web features and weight loss. Telemed J E Health. 2008;14:775–782. doi: 10.1089/tmj.2007.0132.
    1. Schiel R, Beltschikow W, Radon S, Kramer G, Schmiedel R, Berndt RD, Stein G. Long-term treatment of obese children and adolescents using a telemedicine support programme. J Telemed Telecare. 2008;14:13–16. doi: 10.1258/jtt.2007.070504.
    1. Hay PP, Bacaltchuk J, Stefano S, Kashyap P. Psychological treatments for bulimia nervosa and binging. Cochrane Database Syst Rev. 2009. p. CD000562.
    1. Hay PJ, Bacaltchuk J. Bulimia nervosa. Clin Evid (Online) 2008. 2008.
    1. Hay PJ, Bacaltchuk J, Stefano S. Psychotherapy for bulimia nervosa and binging. Cochrane Database Syst Rev. 2004. p. CD000562.
    1. Hay PJ, Bacaltchuk J. Psychotherapy for bulimia nervosa and binging. Cochrane Database Syst Rev. 2003. p. CD000562.
    1. Hay PJ, Bacaltchuk J. Psychotherapy for bulimia nervosa and binging. Cochrane Database Syst Rev. 2001. p. CD000562.
    1. Hay PJ, Bacaltchuk J. Psychotherapy for bulimia nervosa and binging. Cochrane Database Syst Rev. 2000. p. CD000562.
    1. Cooper HM. In: Research methods in personality and social psychology. Hendrik C, Clark MS, editor. Newbury Park: Sage; 1990. Meta-analysis and the integrative research review; pp. 142–163.
    1. Ogden J, Hills L. Understanding sustained behavior change: the role of life crises and the process of reinvention. Health (London) 2008;12:419–437. doi: 10.1177/1363459308094417.
    1. Ogden J, Stavrinaki M, Stubbs J. Understanding the role of life events in weight loss and weight gain. Psychol Health Med. 2009;14:239–249. doi: 10.1080/13548500802512302.
    1. Ryan RM, Patrick H, Deci EL, Williams GC. Facilitating health behaviour change and its maintenance: Interventions based on Self-Determination Theory. The European Health Psychologist. 2008;10:2–5.
    1. Perone R. SCID I/P DSM IV-TR Research Version. 2002.
    1. Chiappelli M, Lo Coco G, Gullo S, Bensi L, Prestano C. [The outcome questionnaire 45.2. Italian validation of an instrument for the assessment of psychological treatments] Epidemiol Psichiatr Soc. 2008;17:152–161.
    1. Lo Coco G, Chiappelli M, Bensi L, Gullo S, Prestano C, Lambert MJ. The factorial structure of the Outcome Questionnaire-45: a study with an Italian sample. Clin Psychol Psychother. 2008;15:418–423. doi: 10.1002/cpp.601.
    1. Lambert MJ, Hansen NB, Umphress V, Lunnen K, Okiishi J, Burlingame GM, Reisenger CW. Administration and scoring manual for the Outcome Questionnaire (OQ 45.2) Stevenson, MD: American Professional Credentialing Services LLC; 1996.
    1. Hatfield DR, Ogles BM. The Use of Outcome Measures by Psychologists in Clinical Practice. Professional Psychology: Research and Practice. 2004;35:485–491.
    1. Lackey NR, Wingate AL. The pilot study: one key to research success. Kans Nurse. 1986;61:6–7.
    1. Brownell KD, Wadden TA. Etiology and treatment of obesity: understanding a serious, prevalent, and refractory disorder. J Consult Clin Psychol. 1992;60:505–517.
    1. Riva G, Bacchetta M, Cesa G, Conti S, Castelnuovo G, Mantovani F, Molinari E. Is severe obesity a form of addiction? Rationale, clinical approach, and controlled clinical trial. Cyberpsychol Behav. 2006;9:457–479. doi: 10.1089/cpb.2006.9.457.
    1. Castelnuovo G, Buselli C, De Ferrari R, Gaggioli A, Mantovani F, Molinari E, Villamira M, Riva G. New tools in cybertherapy: the VEPSY web site. Stud Health Technol Inform. 2004;99:15–35.
    1. Riva G, Botella C, Castelnuovo G, Gaggioli A, Mantovani F, Molinari E. Cybertherapy in practice: the VEPSY updated project. Stud Health Technol Inform. 2004;99:3–14.
    1. Riva G, Alcaniz M, Anolli L, Bacchetta M, Banos R, Buselli C, Beltrame F, Botella C, Castelnuovo G, Cesa G. et al.The VEPSY UPDATED Project: clinical rationale and technical approach. Cyberpsychol Behav. 2003;6:433–439. doi: 10.1089/109493103322278835.
    1. Castelnuovo G, Gaggioli A, Mantovani F, Riva G. From psychotherapy to e-therapy: the integration of traditional techniques and new communication tools in clinical settings. Cyberpsychol Behav. 2003;6:375–382. doi: 10.1089/109493103322278754.
    1. Gaggioli A, Mantovani F, Castelnuovo G, Wiederhold B, Riva G. Avatars in clinical psychology: a framework for the clinical use of virtual humans. Cyberpsychol Behav. 2003;6:117–125. doi: 10.1089/109493103321640301.
    1. Castelnuovo G. No medicine without psychology: the key role of psychological contribution in clinical settings. Frontiers in Psychology for Clinical Settings. 2010;1
    1. Castelnuovo G, Manzoni GM, Cuzziol P, Cesa GL, Tuzzi C, Villa V, Liuzzi A, Petroni ML, Molinari E. TECNOB: study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes. BMC Public Health. p. 204.
    1. Castelnuovo G. Empirically supported treatments in psychotherapy: towards an evidence-based or evidence-biased psychology in clinical settings. Front Psychology. 2010;1:27.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren