Virtual reality for enhancing the cognitive behavioral treatment of obesity with binge eating disorder: randomized controlled study with one-year follow-up.

BACKGROUND: Recent research identifies unhealthful weight-control behaviors (fasting, vomiting, or laxative abuse) induced by a negative experience of the body, as the common antecedents of both obesity and eating disorders. In particular, according to the allocentric lock hypothesis, individuals with obesity may be locked to an allocentric (observer view) negative memory of the body that is no longer updated by contrasting egocentric representations driven by perception. In other words, these patients may be locked to an allocentric negative representation of their body that their sensory inputs are no longer able to update even after a demanding diet and a significant weight loss. OBJECTIVE: To test the brief and long-term clinical efficacy of an enhanced cognitive-behavioral therapy including a virtual reality protocol aimed at unlocking the negative memory of the body (ECT) in morbidly obese patients with binge eating disorders (BED) compared with standard cognitive behavior therapy (CBT) and an inpatient multimodal treatment (IP) on weight loss, weight loss maintenance, BED remission, and body satisfaction improvement, including psychonutritional groups, a low-calorie diet (1200 kcal/day), and physical training. METHODS: 90 obese (BMI>40) female patients with BED upon referral to an obesity rehabilitation center were randomly assigned to conditions (31 to ECT, 30 to CBT, and 29 to IP). Before treatment completion, 24 patients discharged themselves from hospital (4 in ECT, 10 in CBT, and 10 in IP). The remaining 66 inpatients received either 15 sessions of ECT, 15 sessions of CBT, or no additional treatment over a 5-week usual care inpatient regimen (IP). ECT and CBT treatments were administered by 3 licensed psychotherapists, and patients were blinded to conditions. At start, upon completion of the inpatient treatment, and at 1-year follow-up, patients' weight, number of binge eating episodes during the previous month, and body satisfaction were assessed by self-report questionnaires and compared across conditions. 22 patients who received all sessions did not provide follow-up data (9 in ECT, 6 in CBT, and 7 in IP). RESULTS: Only ECT was effective at improving weight loss at 1-year follow-up. Conversely, control participants regained on average most of the weight they had lost during the inpatient program. Binge eating episodes decreased to zero during the inpatient program but were reported again in all the three groups at 1-year follow-up. However, a substantial regain was observed only in the group who received the inpatient program alone, while both ECT and CBT were successful in maintaining a low rate of monthly binge eating episodes. CONCLUSIONS: Despite study limitations, findings support the hypothesis that the integration of a VR-based treatment, aimed at both unlocking the negative memory of the body and at modifying its behavioral and emotional correlates, may improve the long-term outcome of a treatment for obese BED patients. As expected, the VR-based treatment, in comparison with the standard CBT approach, was able to better prevent weight regain but not to better manage binge eating episodes.

Brief Strategic Therapy vs Cognitive Behavioral Therapy for the Inpatient and Telephone-Based Outpatient Treatment of Binge Eating Disorder: The STRATOB Randomized Controlled Clinical Trial.

This paper describes the results of the STRATOB (Systemic and STRATegic psychotherapy for OBesity) study, a two-arm randomized controlled clinical trial (RCT) comparing Brief Strategic Therapy (BST, Nardone or Arezzo model) with the gold standard CBT (Cognitive Behavioral Therapy) for the inpatient and telephone-based outpatient treatment of obese people with Binge Eating Disorder (BED) seeking treatment for weight reduction. Primary outcome measure of the randomized trial was change in the Global Index of the Outcome Questionnaire (OQ 45.2). Secondary outcome measures were BED remission (weekly binge episodes < 2) and weight loss. Data were collected at baseline, at discharge from the hospital (c.a. 1 month after) and after 6 months from discharge.. No significant difference between groups (BST vs CBT) was found in the primary outcome at discharge. However, a greater improvement was seen in the BST vs the CBT group (P<.01) in the primary outcome at 6 months. About secondary outcomes, no significant difference between groups were found in weight change both at discharge and at 6 months. Notably, a significant association emerged between treatment groups and BED remission at 6 months in favor of BST (only 20% of patients in BST group reported a number of weekly binge episodes > 2 vs 63.3% in CBT group).

TECNOB Study: Ad Interim Results of a Randomized Controlled Trial of a Multidisciplinary Telecare Intervention for Obese Patients with Type-2 Diabetes.

BACKGROUND: Obesity increases the risk of many health complications such as hypertension, coronary heart disease and type 2 diabetes, needs long-lasting treatment for effective results and involves high public and private care-costs. Therefore, it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated. Information and communication technologies (ICT) can help clinicians to deliver treatment in a cost-effective and time-saving manner to a large number of obese individuals with co-morbidities. OBJECTIVE: To examine ad interim effectiveness of a 12-month multidisciplinary telecare intervention for weight loss provided to obese patients with type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS: A single-center randomized controlled trial (TECNOB study) started in December 2008. At present, 72 obese patients with type 2 diabetes have been recruited and randomly allocated to the TECNOB program (n=37) or to a control condition (n=39). However, only 34 participants have completed at least the 3-month follow-up and have been included in this ad interim analysis. 21 out of them have reached also the 6-month follow-up and 13 have achieved the end of the program. Study is still on-going. INTERVENTION: All participants attended 1-month inpatient intensive program that involved individualized medical care, diet therapy, physical training and brief psychological counseling. At discharge, participants allocated to the TECNOB program were instructed to use a weight-loss web-site, a web-based videoconference tool, a dietary software installed into their cellular phones and an electronic armband measuring daily steps and energy expenditure. MAIN OUTCOME MEASURES: Weight and disordered eating-related behaviors and cognitions (EDI-2) at entry to hospital, at discharge from hospital, at 3,6 and 12 months. RESULTS: Ad interim analysis of data from 34 participants showed no statistically significant difference between groups in weight change at any time-point. However, within-group analysis revealed significant reductions of initial weight at discharge from hospital, at 3 months, at 6 months but not at 12 months. Control group had higher scores in Interpersonal distrust at 12 months. CONCLUSION: This ad interim findings revealed that the effect of the inpatient treatment was high and probably overwhelmed the effect of the TECNOB intervention. Much statistical power and long-term follow-up may enhance the probability to detect the TECNOB effect over and above the great one exerted by the inpatient program.

TECNOB: study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes.

BACKGROUND: Obesity is one of the most important medical and public health problems of our time: it increases the risk of many health complications such as hypertension, coronary heart disease and type 2 diabetes, needs long-lasting treatment for effective results and involves high public and private costs. Therefore, it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated. METHODS/DESIGN: TECNOB (TEChnology for OBesity) is a comprehensive two-phase stepped down program enhanced by telemedicine for the long-term treatment of obese people with type 2 diabetes seeking intervention for weight loss. Its core features are the hospital-based intensive treatment (1-month), that consists of diet therapy, physical training and psychological counseling, and the continuity of care at home using new information and communication technologies (ICT) such as internet and mobile phones. The effectiveness of the TECNOB program compared with usual care (hospital-based treatment only) will be evaluated in a randomized controlled trial (RCT) with a 12-month follow-up. The primary outcome is weight in kilograms. Secondary outcome measures are energy expenditure measured using an electronic armband, glycated hemoglobin, binge eating, self-efficacy in eating and weight control, body satisfaction, healthy habit formation, disordered eating-related behaviors and cognitions, psychopathological symptoms and weight-related quality of life. Furthermore, the study will explore what behavioral and psychological variables are predictive of treatment success among those we have considered. DISCUSSION: The TECNOB study aims to inform the evidence-based knowledge of how telemedicine may enhance the effectiveness of clinical interventions for weight loss and related type-2 diabetes, and which type of obese patients may benefit the most from such interventions. Broadly, the study aims also to have a effect on the theoretical model behind the traditional health care service, in favor of a change towards a new "health care everywhere" approach.

Do coping strategies discriminate eating disordered individuals better than eating disorder features? An explorative study on female inpatients with anorexia and bulimia nervosa.

The purpose of this explorative research was to examine how the COPE (Coping Orientation to Problem Experienced Inventory), an established instrument for measuring coping styles, and EDI-2 (Eating Disorder Inventory-2), a widely used questionnaire for assessing psychological and behavioural features of eating disorders (ED), discriminate among healthy individuals, inpatients with anorexia nervosa (AN) and inpatients with bulimia nervosa (BN). A discriminant analysis approach was used. Results showed that coping styles such as positive attitude, planning and social support are even more discriminative variables than eating disorder features. Implications for further studies are discussed.

Virtual Reality-Enhanced Cognitive-Behavioral Therapy for Morbid Obesity: A Randomized Controlled Study with 1 Year Follow-Up.

It is well known that obesity has a multifactorial etiology, including biological, environmental, and psychological causes. For this reason, obesity treatment requires a more integrated approach than the standard behavioral treatment based on dietary and physical activity only. To test the long-term efficacy of an enhanced cognitive-behavioral therapy (CBT) of obesity, including a virtual reality (VR) module aimed at both unlocking the negative memory of the body and to modify its behavioral and emotional correlates, 163 female morbidly obese inpatients (body mass index >40) were randomly assigned to three conditions: a standard behavioral inpatient program (SBP), SBP plus standard CBT, and SBP plus VR-enhanced CBT. Patients' weight, eating behavior, and body dissatisfaction were measured at the start and upon completion of the inpatient program. Weight was assessed also at 1 year follow-up. All measures improved significantly at discharge from the inpatient program, and no significant difference was found among the conditions. However, odds ratios showed that patients in the VR condition had a greater probability of maintaining or improving weight loss at 1 year follow-up than SBP patients had (48% vs. 11%, p = 0.004) and, to a lesser extent, than CBT patients had (48% vs. 29%, p = 0.08). Indeed, only the VR-enhanced CBT was effective in further improving weight loss at 1 year follow-up. On the contrary, participants who received only the inpatient program regained back, on average, most of the weight they had lost. Findings support the hypothesis that a VR module addressing the locked negative memory of the body may enhance the long-term efficacy of standard CBT.

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.

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