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Year of Publication
1.  Impact of Fibromyalgia on Functioning in Obese Patients Undergoing Comprehensive Rehabilitation 
PLoS ONE  2014;9(3):e91392.
A possible link between fibromyalgia (FM) and obesity has been recently suggested but very scanty data on the prevalence of FM in obese populations are available. The aims of the present cross-sectional study were: 1) to estimate the prevalence of FM in a population of obese patients undergoing rehabilitation and 2) to investigate the effect of FM on obese patients' functional capacities. One hundred and thirty Italian obese (Body Mass Index, BMI ≥30) patients admitted to hospital for 1-month rehabilitation treatment took part in the study. All participants were interviewed by a rheumatologist according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for FM. At admission and discharge from hospital (on average, after 28 days), the following measures were compared between the group of patients with FM and the other patients: body weight, body mass index, functional independence (FIM), obesity-related disability (TSD-OC), self-reported functioning and the Timed-Up-Go (TUG) test. Thirty seven patients out of 130 fulfilled the diagnostic criteria for FM. The prevalence rate was 27.7% (95% CI: 20 to 35.4). Between-group comparisons showed that FM patients had higher disability level at the first assessment, had lower scores on the FIM at the final assessment, scored lower on self-reported functioning both at the first and the final assessments and had a lower body weight. The prevalence of FM in our study is much higher than the rates reported in the general normal-weight population (on average, 3.5%) and the 5.15% rate previously reported in a bariatric population. Functional data showed that the FM obese group yielded lower performance capacity and higher disability level as compared to the non-FM obese group. However, due to the relatively small sample size and the selected population, such results need to be confirmed in larger obese subpopulations.
doi:10.1371/journal.pone.0091392
PMCID: PMC3949991  PMID: 24618795
2.  The ACTonHEART study: rationale and design of a randomized controlled clinical trial comparing a brief intervention based on Acceptance and Commitment Therapy to usual secondary prevention care of coronary heart disease 
Background
Modifiable risk factors, including life-style habits and psychological variables, have been increasingly demonstrated to have an important role in influencing morbidity and mortality in cardiovascular patients, and to account for approximately 90% of the population risk for cardiac events.
Acceptance and Commitment Therapy (ACT) has shown effectiveness in promoting healthy behaviors, and improving psychological well-being in patients with chronic physical conditions. Moreover, a first application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour. However, no clinical trial to date has evaluated the efficacy of an acceptance-based program for the modification of cardiovascular risk factors and the improvement of psychological well-being, compared to usual secondary prevention care.
Methods
Approximately 168 patients will be recruited from an outpatient cardiac rehabilitation unit and randomly assigned to receive usual care or usual care + a brief ACT-based intervention. The ACT group will be administered five group therapy sessions integrating educational topics on heart-healthy behaviours with acceptance and mindfulness skills. Participants will be assessed at baseline, six weeks later (post treatment for the ACT condition), at six and twelve months follow-up.
A partially-nested design will be used to balance effects due to clustering of participants into small therapy groups. Primary outcome measures will include biological indicators of cardiovascular risk and self-reported psychological well-being. Treatment effects will be tested via multilevel modeling after which the mediational role of psychological flexibility will be evaluated.
Discussion
The ACTonHEART study is the first randomized clinical trial designed to evaluate the efficacy of a brief group-administered, ACT-based program to promote health behavior change and psychological well-being among cardiac patients. Results will address the effectiveness of a brief treatment created to simultaneously impact multiple cardiovascular risk factors. Conducted in the context of clinical practice, this trial will potentially offer empirical support to alternative interventions to improve quality of life and reduce mortality and morbidity rates among cardiac patients.
Trial registration
clinicaltrials.gov/ (NCT01909102)
doi:10.1186/1477-7525-12-22
PMCID: PMC3936953  PMID: 24552555
Ischemic heart disease; Modifiable cardiovascular risk factors; Adherence; Psychological well-being; Quality of life; Acceptance and Commitment Therapy; Behavior modification; Randomized clinical trial
3.  Motivation in psychocardiological rehabilitation 
doi:10.3389/fpsyg.2013.00827
PMCID: PMC3818470
motivation; cardiological rehabilitation; stroke rehabilitation; psychocardiology; cardiac psichology
4.  5 years after the Kahn's etiquette-based medicine: a brief checklist proposal for a functional second meeting with the patient 
doi:10.3389/fpsyg.2013.00723
PMCID: PMC3805935  PMID: 24167493
etiquette-based medicine; communication; clinical psychology; relationships; strategy
5.  Social support, depression, and heart disease: a ten year literature review 
Background: Coronary heart disease is the major cause of morbidity and mortality in the world. Psychosocial factors such as depression and low social support are established risk factors for poor prognosis in patients with heart disease. However, little is known about the hypothetical relationship pattern between them.
Purpose: The purposes of this narrative review are (1) to appraise the 2002–2012 empirical evidence about the multivariate relationship between depression, social support and health outcomes in patients with heart disease; (2) to evaluate the methodological quality of included studies.
Method: PubMed and PsychINFO were searched for quantitative studies assessing the multiple effects of low social support and depression on prognosis outcomes in patients with heart disease. The following search terms were used: social relation*, cardiac disease, support quality, relationship, and relational support.
Results: Five studies (three prospective cohort studies, one case-control study, and one randomization controlled trial) were selected and coded according to the types of support (social and marital). The majority of findings suggests that low social support/being unmarried and depression are independent risk factors for poor cardiac prognosis. However, all analyzed studies have some limitations. The majority of them did not focus on the quality of marital or social relationships, but assessed only the presence of marital status or social relationship. Moreover, some of them present methodological limitations.
Conclusion: Depressive symptoms and the absence of social or marital support are significant risk factors for poor prognosis in cardiac patients and some evidence supports their independence in predicting adverse outcomes. Cardiac rehabilitation and prevention programs should thus include not only the assessment and treatment of depression but also a specific component on the family and social contexts of patients.
doi:10.3389/fpsyg.2013.00384
PMCID: PMC3696881  PMID: 23847561
depression; cardiac disease; social support; marital status; social relationship
6.  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.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 59019572; http://www.controlled-trials.com/ISRCTN59019572 (Archived by WebCite at http://www.webcitation.org/6GxHxAR2G)
doi:10.2196/jmir.2441
PMCID: PMC3713949  PMID: 23759286
virtual reality; obesity; binge eating disorders; allocentric lock hypothesis
7.  The Power Semantics in Self and Other Repertory Grid Representations: A Comparison between Obese and Normal-Weight Adult Women 
According to systemic-constructivist theory, all psycho-pathological organizations are linked to specific meanings which are developed by the individual within problematic situations in the context of learning, particularly within the family. The aim of this empirical study is to support the theory that eating disorders are linked to the “power semantics,” concept developed by Ugazio. The hypothesis that the bipolar construct “winner/loser” and the associated meanings are predominant for obese people, has been verified by interviewing 44 women (22 obese/overweight; 22 controls) using the Repertory Grid Test developed by Kelly. The participants’ elicited constructs were classified according to their semantic content and the data compared using statistical techniques. The power semantics were more prevalent and important in the Obese Group than in the Control Group. These results are critically discussed, highlighting possible clinical developments.
doi:10.3389/fpsyg.2012.00517
PMCID: PMC3525515  PMID: 23267334
obesity; meanings; repertory grid test
8.  Change in Psychotherapy: A Dialogical Analysis Single-Case Study of a Patient with Bulimia Nervosa 
Starting from the critical review of various motivational frameworks of change that have been applied to the study of eating disorders, the present paper provides an alternative conceptualization of the change in psychotherapy presenting a single-case study. We analyzed six psychotherapeutic conversations with a bulimic patient and found out narratives “for” and “against” change. We read them in terms of tension between dominance and exchange in I-positions, as described by Hermans. These results indicate that the dialogical analysis of clinical discourse may be a useful method to investigate change from the beginning to the end of therapy.
doi:10.3389/fpsyg.2012.00546
PMCID: PMC3516705  PMID: 23233845
dialogical self; I-positions; motivation for change; psychotherapy; discourse analysis; relational perspective
12.  Respiratory function of people with amyotrophic lateral sclerosis and caregiver distress level: a correlational study 
Background
Amyotrophic Lateral Sclerosis (ALS) is a rare, fatal neurodegenerative disorder with no curative treatment characterized by degeneration of motor neurons involving a progressive impairment of motor and respiratory functions. Most patients die of ventilator respiratory failure. Caregivers have a great influence on the patient”s quality of life as well as on the quality of care. Home influence of the caregiver on patient care is notable. To date, no study has investigated how psychological issues of caregivers would influence respiratory variables of ALS patients. The study aimed at finding out if there is a relationship between the respiratory function of ALS patients and the level of distress of their caregivers.
Methods
A cross-sectional study was conducted to investigate respiratory issues (PCF and FVC) and the perception of social support of ALS patients. Caregivers filled questionnaires about trait anxiety, depression, and burden of care. Forty ALS patients and their caregivers were recruited.
Results
FVC and PCF were positively related to patient perception of social support and negatively related to caregiver anxiety, depression, and burden.
Discussion
The distress of ALS caregivers is related to patient respiratory issues. The first and more intuitive explanation emphasizes the impact that the patient’s clinical condition has with respect to the caregiver. However, it is possible to hypothesize that if caregivers feel psychologically better, their patient’s quality of life improves and that a condition of greater well-being and relaxation could also increase ventilatory capacity. Furthermore, care management could be carried out more easily by caregivers who pay more attention to the patient's respiratory needs.
Conclusion
Patient perception of social support and caregiver distress are related to respiratory issues in ALS.
doi:10.1186/1751-0759-6-14
PMCID: PMC3472192  PMID: 22721255
Quality of life; Bio-psycho-social interaction; Amyotrophic lateral sclerosis; Non-invasive ventilation; Health care; Caregivers
13.  The WRITTEN-HEART study (expressive writing for heart healing): rationale and design of a randomized controlled clinical trial of expressive writing in coronary patients referred to residential cardiac rehabilitation 
Background
Coronary heart disease (CHD) is typically associated with many cardiovascular risk factors (e.g., elevated blood pressure), low health-related quality of life, depression, anxiety and psychological stress. Expressive writing (EW) has shown beneficial effects on such variables in both people from the community and in patients with a variety of chronic illnesses. However, no study to date has evaluated the physical and psychological effects of the expressive writing procedure on coronary patients referred to cardiac rehabilitation (CR).
Methods
The clinical effectiveness of a 2-week disease-related expressive writing procedure (writing about one's deepest thoughts and feelings regarding the experience with heart disease) compared with the standard writing task (writing about one's deepest thoughts and feelings about the most traumatic or negative event experienced in the life), a neutral writing condition (writing about the facts regarding heart disease and its treatment) and an empty control condition will be evaluated in a randomized controlled clinical trial (RCT) with repeated follow-up measurements at 3, 6 and 12 months after discharge from CR. The primary outcome is health-related quality of life (SF-12). Secondary outcome measures are depression (BDI-II), anxiety (BAI) and post-traumatic growth (PTGI). Furthermore, the study will explore the moderating effects of coping styles, type D personality, perceived emotional support and participants' evaluative ratings of the writing interventions on the main experimental effects in order to identify sub-groups of patients showing different results.
Discussion
The WRITTEN-HEART study aims to explore and expand the frontiers of the expressive writing research enterprise by investigating the feasibility, safety and clinical efficacy of brief and cost-effective expressive writing interventions in patients with CHD referred to CR.
Trial registration
ClinicalTrials.gov NCT01253486
doi:10.1186/1477-7525-9-51
PMCID: PMC3151200  PMID: 21740564
14.  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 
Trials  2011;12:114.
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 tipically 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
doi:10.1186/1745-6215-12-114
PMCID: PMC3113986  PMID: 21554734
15.  Time for the single researcher impact factor 
BMJ : British Medical Journal  2008;336(7648):789.
doi:10.1136/bmj.39542.514745.3A
PMCID: PMC2292290  PMID: 18403509
16.  Internet-Based Behavioral Interventions for Obesity: An Updated Systematic Review 
The objective of this systematic review is to update a previous systematic review on the effectiveness of internet-based interventions for weight loss and weight loss maintenance in overweight and obese people with new or additional studies. A literature search from 2008 to March 2010 was conducted. Studies were eligible for inclusion if: participants were adults with a body mass index ≤ 25, at least one study arm involved an internet-based intervention and the primary aims were weight loss or maintenance. Eight additional studies over the eighteen included in the previous review met the inclusion criteria. Data were extracted on sample characteristics, attrition, weight loss, duration of treatment and maintenance of weight loss. Effect sizes (Hedges g) and relative 95% confidence intervals were calculated for all two-way comparisons within each study. No attempt was made to pool the data in a meta-analysis because of the great heterogeneity of designs among studies. An examination of effect sizes show that the higher significant effects pertain studies that found a superiority of behavioral internet-based programs enhanced by features such as tailored feedback on self-monitoring of weight, eating and activity over education only internet-based interventions. However, control groups are very different among studies and this heterogeneity probably accounts for much of the variance in effect sizes. Hence, questions still remain as to the effectiveness of web-based interventions in achieving weight loss or maintenance. Implications for further research include using a “real” control group in order to make meta-analysis possible and developing multi-factorial design in order to separate components of interventions and identify which of them or patterns of them are keys to success.
doi:10.2174/1745017901107010019
PMCID: PMC3087973  PMID: 21552423
Internet; obesity; systematic review; meta-analysis; weight loss; weight loss maintenance.
18.  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.
doi:10.2174/1745017901107010044
PMCID: PMC3089038  PMID: 21559233
Obesity; type-2 diabetes; weight loss; weight loss maintenance; telemedicine; telecare; RCT.
19.  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).
doi:10.2174/1745017901107010029
PMCID: PMC3089039  PMID: 21559234
Brief strategic therapy – BST; cognitive behavioural therapy – CBT; binge-eating disorder – BED; clinical psychology; obesità; telecare; psychotherapy.
20.  A More Comprehensive Index in the Evaluation of Scientific Research: The Single Researcher Impact Factor Proposal 
Good alternatives to the Impact Factor (IF) algorithm are needed. The Thomson IF represents a limited measure of the importance of an individual article because 80% of a journal's IF is determined by only the 20% of the papers published. In the past few years, several new indexes has been created to provide alternatives to the IF algorithm. These include the removal of self citations from the calculation of the IF using the Adjusted IF, Index Copernicus initiative and other modifications such as the Cited Half-Life IF, Median IF, Disciplinary IF, and Prestige Factor. There is also the Euro-Factor, born in Europe to avoid the strong US centrality, and the English language basis of the Thomson database. One possible strategy to avoid "IF supremacy" is to create a new index, the Single Researcher Impact Factor (SRIF), that would move the evaluation from the power of scientific journals to the quality of single researchers. This measure can take into account the number and quality of the traditional publications and other activities usually associated with being a researcher, such as reviewing manuscripts, writing books, and attending scientific meetings. Also, in funding policy, it might be more useful to consider the merits, contributions, and real impact of all the scientific activities of a single researcher instead of adding only the journals' IF numbers. The major aim of this paper is to propose and describe the SRIF index that could represent a novel option to evaluate scientific research and researchers.
doi:10.2174/1745017901006010109
PMCID: PMC3040994  PMID: 21339895
Impact Factor; Scientific Journal; Single Researcher; Scientific Evaluation.
21.  Psychological Well-Being in Obese Inpatients with Ischemic Heart Disease at Entry and at Discharge from a Four-Week Cardiac Rehabilitation Program 
The purposes of this observational pre-post study were twofold: 1- to evaluate psychological health in obese patients with ischemic heart disease at admission to cardiac rehabilitation (CR) and 2 – to examine the effectiveness of a 4-week CR residential program in improving obese patients’ psychological well-being at discharge from CR. A sample of 177 obese patients completed the Psychological General Well-Being Inventory (PGWBI) at admission to the CR program and at discharge. The equivalence testing method with normative comparisons was used to determine the clinical significance of improvements after having established that baseline mean scores on the PGWBI scales were significantly lower than normal means. Results show that patients scored equally or better than norms on many PGWBI dimensions at admission to CR but scored significantly worse on Global Score, Vitality and Self-control. At discharge, mean scores that were impaired at baseline returned to normal levels at the more conservative equivalence interval. A 4-week CR program was thus effective in improving obese patients’ psychological well-being. The equivalence testing method allowed to establish the clinical significance of such improvement.
doi:10.3389/fpsyg.2010.00038
PMCID: PMC3153756  PMID: 21833207
cardiac rehabilitation; psychological well-being; mental health; obesity; weight loss
22.  Empirically Supported Treatments in Psychotherapy: Towards an Evidence-Based or Evidence-Biased Psychology in Clinical Settings? 
The field of research and practice in psychotherapy has been deeply influenced by two different approaches: the empirically supported treatments (ESTs) movement, linked with the evidence-based medicine (EBM) perspective and the “Common Factors” approach, typically connected with the “Dodo Bird Verdict”. About the first perspective, since 1998 a list of ESTs has been established in mental health field. Criterions for “well-established” and “probably efficacious” treatments have arisen. The development of these kinds of paradigms was motivated by the emergence of a “managerial” approach and related systems for remuneration also for mental health providers and for insurance companies. In this article ESTs will be presented underlining also some possible criticisms. Finally complementary approaches, that could add different evidence in the psychotherapy research in comparison with traditional EBM approach, are presented.
doi:10.3389/fpsyg.2010.00027
PMCID: PMC3153746  PMID: 21833197
evidence based medicine; evidence based psychology; empirically supported treatments; psychotherapy research; common factors
23.  TECNOB: study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes 
BMC Public Health  2010;10:204.
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.
Trial registration
Current Controlled Trials ISRCTN07265661
doi:10.1186/1471-2458-10-204
PMCID: PMC2873580  PMID: 20416042
25.  Weight, Blood Pressure, and Dietary Benefits After 12 Months of a Web-based Nutrition Education Program (DASH for Health): Longitudinal Observational Study 
Background
The dietary habits of Americans are creating serious health concerns, including obesity, hypertension, diabetes, cardiovascular disease, and even some types of cancer. While considerable attention has been focused on calorie reduction and weight loss, approaches are needed that will not only help the population reduce calorie intake but also consume the type of healthy, well-balanced diet that would prevent this array of medical complications.
Objective
To design an Internet-based nutrition education program and to explore its effect on weight, blood pressure, and eating habits after 12 months of participation.
Methods
We designed the DASH for Health program to provide weekly articles about healthy nutrition via the Internet. Dietary advice was based on the DASH diet (Dietary Approaches to Stop Hypertension). The program was offered as a free benefit to the employees of EMC Corporation, and 2834 employees and spouses enrolled. Enrollees voluntarily entered information about themselves on the website (food intake), and we used these self-entered data to determine if the program had any effect. Analyses were based upon the change in weight, blood pressure, and food intake between the baseline period (before the DASH program began) and the 12th month. To be included in an outcome, a subject had to have provided both a baseline and 12th-month entry.
Results
After 12 months, 735 of 2834 original enrollees (26%) were still actively using the program. For subjects who were overweight/obese (body mass index > 25; n = 151), weight change at 12 months was -4.2 lbs (95% CI: -2.2, -6.2; P < .001). For subjects with hypertension or prehypertension at baseline (n = 62), systolic blood pressure fell 6.8 mmHg at 12 months (CI: -2.6, -11.0; P < .001; n = 62). Diastolic pressure fell 2.1 mmHg (P = .16). Based upon self-entered food surveys, enrollees (n = 181) at 12 months were eating significantly more fruits, more vegetables, and fewer grain products. They also reduced consumption of carbonated beverages. Enrollees who had visited the website more often tended to have greater blood pressure and weight loss effect, suggesting that use of the DASH for Health program was at least partially responsible for the benefits we observed.
Conclusions
We have found that continued use of a nutrition education program delivered totally via the Internet, with no person-to-person contact with health professionals, is associated with significant weight loss, blood pressure lowering, and dietary improvements after 12 months. Effective programs like DASH for Health, delivered via the Internet, can provide benefit to large numbers of subjects at low cost and may help address the nutritional public health crisis.
doi:10.2196/jmir.1114
PMCID: PMC2629362  PMID: 19073541
Weight loss; blood pressure; hypertension; health education; diet; Internet; behavior change

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