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1.  Managing chronic pathologies with a stepped mHealth-based approach in clinical psychology and medicine 
Chronic diseases and conditions typically require long-term monitoring and treatment protocols both in traditional settings and in out-patient frameworks. The economic burden of chronic conditions is a key challenge and new and mobile technologies could offer good solutions. mHealth could be considered an evolution of eHealth and could be defined as the practice of medicine and public health supported by mobile communication devices. mHealth approach could overcome limitations linked with the traditional, restricted, and highly expensive in-patient treatment of many chronic pathologies. Possible applications include stepped mHealth approach, where patients can be monitored and treated in their everyday contexts. Unfortunately, many barriers for the spread of mHealth are still present. Due the significant impact of psychosocial factors on disease evolution, psychotherapies have to be included into the chronic disease protocols. Existing psychological theories of health behavior change have to be adapted to the new technological contexts and requirements. In conclusion, clinical psychology and medicine have to face the “chronic care management” challenge in both traditional and mHealth settings.
PMCID: PMC4396192  PMID: 25926801
chronic care management; mHealth; e-health; clinical psychology; new technologies; rehabilitation; behavioral medicine; health psychology
2.  Meditation Training for People with Amyotrophic Lateral Sclerosis and Their Caregivers 
Objectives: Amyotrophic lateral sclerosis (ALS) is a progressive and fatal neurodegenerative disease that is clinically characterized by progressive weakness leading to death by respiratory insufficiency, usually within three years. Although the patient's intellect and personality usually remain unimpaired, as the disease progresses, the patient becomes immobile, develops wasting, and speech becomes impaired, often resulting in social isolation and a high degree of psychological suffering. Mindfulness meditation has proven to be effective technique for reducing distress in many chronic diseases. However, to date, no study has investigated the effect of mindfulness meditation on patients with ALS.
Design: A mindfulness meditation training program for ALS patients needs to consider the particularities of ALS symptoms, including the loss of muscular functions and difficulties in respiration, together with the subsequent emotional impairments. With these caveats in mind, a modified protocol, based on original mindfulness meditation interventions, has been created specifically for the ALS population.
This article describes the protocol and preliminary results.
PMCID: PMC3994974  PMID: 24328393
3.  Development and initial validation of the Cardiovascular Disease Acceptance and Action Questionnaire (CVD-AAQ) in an Italian sample of cardiac patients 
Frontiers in Psychology  2014;5:1284.
Psychological inflexibility refers to the attempt to decrease internal distress even when doing so is inconsistent with life values, and has been identified as a potential barrier to making and maintaining health behavior changes that are consistent with a heart-healthy lifestyle. Disease- and behavior-specific measures of psychological inflexibility have been developed and utilized in treatment research. However, no specific measure has been created for patients with heart disease. Thus, the CardioVascular Disease Acceptance and Action Questionnaire (CVD-AAQ) was developed. The present study is aimed to evaluate the psychometric properties of the CVD-AAQ and to explore its association with measures of psychological adjustment and cardiovascular risk factors in an Italian sample of 275 cardiac patients. Exploratory factor analysis showed a structural one-factor solution with satisfactory internal consistency and test–retest reliability. The relation with other measures was in the expected direction with stronger correlations for the theoretically consistent variables, supporting convergent and divergent validity. CVD-AAQ scores were associated with general psychological inflexibility, anxiety and depression and inversely correlated with psychological well-being. Moreover, the results showed that CVD-AAQ scores are associated with two relevant risk factors for cardiac patients, namely low adherence to medication and being overweight. In sum, results suggest that the CVD-AAQ is a reliable and valid measure of heart disease-specific psychological inflexibility with interesting clinical applications for secondary prevention care.
PMCID: PMC4231832  PMID: 25452737
psychological inflexibility; acceptance; cardiovascular disease; adherence to treatment; experiential avoidance; Cardiovascular Disease Acceptance and Action Questionnaire
4.  Effectiveness of group reminiscence for improving wellbeing of institutionalized elderly adults: study protocol for a randomized controlled trial 
Trials  2014;15:408.
Group reminiscence therapy is a brief and structured intervention in which participants share personal past events with peers. This approach has been shown to be promising for improving wellbeing and reducing depressive symptoms among institutionalized older adults. However, despite the considerable interest in reminiscence group therapy, controlled studies to determine its specific benefits as compared to generic social interactions with peers (group conversations about everyday subjects) are still lacking.
We have designed a randomized controlled trial aimed at comparing the effects of group reminiscence therapy with those of group recreational activity on the psychological wellbeing of an institutionalized sample of older adults. The study includes two groups of 20 hospitalized elderly participants: the experimental group and the control group. Participants included in the experimental group will receive six sessions of group reminiscence therapy, while the control group will participate in a recreational group discussion. A repeated-measures design will be used post-intervention and three months post-intervention to evaluate changes in self-reported outcome measures of depressive symptoms, self-esteem, life satisfaction, and quality of life from baseline.
The protocol of a study aimed at examining the specific effects of group reminiscence therapy on psychological wellbeing, depression, and quality of life among institutionalized elderly people is described. It is expected that the outcomes of this trial will contribute to our knowledge about the process of group reminiscence, evaluate its effectiveness in improving psychological wellbeing of institutionalized individuals, and identify the best conditions for optimizing this approach.
Trial registration
This trial was registered with (registration number: NCT02077153) on 31 January 2014.
PMCID: PMC4216871  PMID: 25344703
Reminiscence; Group Activities; Group Reminiscence; Older Adults
5.  Obesity and outpatient rehabilitation using mobile technologies: the potential mHealth approach 
Obesity is currently an important public health problem of epidemic proportions (globesity). Inpatient rehabilitation interventions that aim at improving weight-loss, reducing obesity-related complications and changing dysfunctional behaviors, should ideally be carried out in a multidisciplinary context with a clinical team composed of psychologists, dieticians, psychiatrists, endocrinologists, nutritionists, physiotherapists, etc. Long-term outpatient multidisciplinary treatments are likely to constitute an essential aspect of rehabilitation. Internet-based technologies can improve long-term obesity rehabilitation within a collaborative approach by enhancing the steps specified by psychological and medical treatment protocols. These outcomes may be augmented further by the mHealth approach, through creating new treatment delivery methods to increase compliance and engagement. mHealth (m-health, mobile health) can be defined as the practice of medicine and public health, supported by mobile communication devices for health services and information. mHealth applications which can be implemented in weight loss protocols and obesity rehabilitation are discussed, taking into account future research directions in this promising area.
PMCID: PMC4051130  PMID: 24959157
obesity; rehabilitation; telemedicine; telecare; mHealth; clinical psychology; health psychology; psychotherapy
6.  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 
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.
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.
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 (NCT01909102)
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
7.  Virtual Reality for Enhancing the Cognitive Behavioral Treatment of Obesity With Binge Eating Disorder: Randomized Controlled Study With One-Year Follow-up 
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.
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.
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).
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.
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; (Archived by WebCite at
PMCID: PMC3713949  PMID: 23759286
virtual reality; obesity; binge eating disorders; allocentric lock hypothesis
8.  Right-sided rhabdoid colorectal tumors might be related to the Serrated Pathway 
Diagnostic Pathology  2013;8:31.
Rhabdoid colorectal tumor (RCT) is a rare, highly aggressive neoplasm recurrent in elderly patients, commonly at the caecum. The molecular mechanisms underlying RCT pathogenesis remain poorly elucidated. The differential diagnosis is with the malignant rhabdoid tumors of infancy characterized by genetic inactivation of SMARCB1 (INI1) or deletions of chromosome 22q12 locus.
Materials and methods
To shed light on RCT pathogenesis, we investigated genetic and epigenetic alterations in two cases of pure and composite RCT and compared them with the profiles of matched adenomas and normal mucosa. Immunohistochemical analysis, FISH, methylation specific PCR and DNA sequencing analysis were performed on paraffin-embedded tissues.
Loss of epithelial markers, (CK20, CDX2 and E-cadherin) and intense vimentin expression was observed in RCTs but neither in the normal mucosa or adenomas. INI1 expression was detected in normal mucosa, adenomas and retained in pure RCT, while it was undetected in composite RCT. Rearrangement of the 22q12 locus was found only in pure RCT. The APC/β-catenin pathway was not altered, while MLH1 immunostaining was negative in RCTs and positive in adenomas and normal mucosa. These expression profiles were associated with V600E BRAF mutation, a progressive accumulation of promoter methylation at specific CIMP loci and additional genes from the normal mucosa to tubular adenoma and RCT.
Right-sided RCT could be characterized by epigenetic events and molecular features likely similar to those occurring in the serrated pathway and associated with epithelial-mesenchymal transition. These extremely rare tumors may benefit from the use of new biological molecules specific for colorectal carcinoma.
Virtual slides
The virtual slide(s) for this article can be found here:
PMCID: PMC3640919  PMID: 23425390
Rhabdoid Colorectal Tumor, RCT; CpG island methylator phenotype, CIMP; Serrated pathway
10.  WELL.ME - Wellbeing therapy based on real-time personalized mobile architecture, vs. cognitive therapy, to reduce psychological distress and promote healthy lifestyle in cardiovascular disease patients: study protocol for a randomized controlled trial 
Trials  2012;13:157.
There is compelling evidence that psychological factors may have the same or even greater impact on the possibility of adverse events on cardiac diseases (CD) than other traditional clinical risk factors. Anxiety and depression are predictors of short- and long-term adverse outcomes, increased risk for higher rates of in-hospital complications, re-infarction, malignant arrhythmias, and mortality in CD patients. Despite researchers finding that cognitive behavior therapy (CBT) reduced depressive and anxiety symptoms, the fact that such results are maintained only in the short term and the lack of maintenance of the long-term affects the absence of changes in lifestyles, preventing the possibility of a wide generalization of results. Recently wellbeing therapy (WBT) has been proposed as a useful approach to improve healthy lifestyle behaviors and reduce psychological distress.
The present randomized controlled study will test WBT, in comparison with CBT, as far as the reduction of symptoms of depression, anxiety and psychological distress, and the improvement of lifestyle behaviors and quality of life in cardiac patients are concerned. Moreover, innovations in communication technologies allow patients to be constantly followed in real life. Therefore WBT based on personalized mobile technology will allow the testing of its effectiveness in comparison with usual WBT.
The present study is a large outpatient study on the treatment of co-morbid depression, anxiety, and psychological distress in cardiac patients. The most important issues of this study are its randomized design, the focus on promotion of health-related behaviors, and the use of innovative technologies supporting patients’ wellbeing in real life and in a continuous way. First results are expected in 2012.
Trial registration Identifier: NCT01543815.
PMCID: PMC3492018  PMID: 22943627
Anxiety; Depression; Psychological distress; Cognitive behavior therapy; Wellbeing therapy; Mobile technology; Cardiac disease
11.  Respiratory function of people with amyotrophic lateral sclerosis and caregiver distress level: a correlational study 
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.
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.
FVC and PCF were positively related to patient perception of social support and negatively related to caregiver anxiety, depression, and burden.
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.
Patient perception of social support and caregiver distress are related to respiratory issues in ALS.
PMCID: PMC3472192  PMID: 22721255
Quality of life; Bio-psycho-social interaction; Amyotrophic lateral sclerosis; Non-invasive ventilation; Health care; Caregivers
12.  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 
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).
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.
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 NCT01253486
PMCID: PMC3151200  PMID: 21740564
13.  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.
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.
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.
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 Identifier: NCT01096251
PMCID: PMC3113986  PMID: 21554734
14.  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.
PMCID: PMC3087973  PMID: 21552423
Internet; obesity; systematic review; meta-analysis; weight loss; weight loss maintenance.
15.  TECNOB Study: Ad Interim Results of a Randomized Controlled Trial of a Multidisciplinary Telecare Intervention for Obese Patients with Type-2 Diabetes  
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.
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.
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.
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.
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.
PMCID: PMC3089038  PMID: 21559233
Obesity; type-2 diabetes; weight loss; weight loss maintenance; telemedicine; telecare; RCT.
16.  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).
PMCID: PMC3089039  PMID: 21559234
Brief strategic therapy – BST; cognitive behavioural therapy – CBT; binge-eating disorder – BED; clinical psychology; obesità; telecare; psychotherapy.
17.  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.
PMCID: PMC3040994  PMID: 21339895
Impact Factor; Scientific Journal; Single Researcher; Scientific Evaluation.
18.  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.
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.
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.
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
PMCID: PMC2873580  PMID: 20416042
19.  Relaxation training for anxiety: a ten-years systematic review with meta-analysis 
BMC Psychiatry  2008;8:41.
Relaxation training is a common treatment for anxiety problems. Lacking is a recent quantitative meta-analysis that enhances understanding of the variability and clinical significance of anxiety reduction outcomes after relaxation treatment.
All studies (1997–2007), both RCT, observational and without control group, evaluating the efficacy of relaxation training (Jacobson's progressive relaxation, autogenic training, applied relaxation and meditation) for anxiety problems and disorders were identified by comprehensive electronic searches with Pubmed, Psychinfo and Cochrane Registers, by checking references of relevant studies and of other reviews. Our primary outcome was anxiety measured with psychometric questionnaires. Meta-analysis was undertaken synthesizing the data from all trials, distinguishing within and between effect sizes.
27 studies qualified for the inclusion in the meta-analysis. As hypothesized, relaxation training showed a medium-large effect size in the treatment of anxiety. Cohen's d was .57 (95% CI: .52 to .68) in the within analysis and .51 (95% CI: .46 to .634) in the between group analysis. Efficacy was higher for meditation, among volunteers and for longer treatments. Implications and limitations are discussed.
The results show consistent and significant efficacy of relaxation training in reducing anxiety. This meta-analysis extends the existing literature through facilitation of a better understanding of the variability and clinical significance of anxiety improvement subsequent to relaxation training.
PMCID: PMC2427027  PMID: 18518981

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