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Efficacy of an internet-based exposure treatment for flying phobia (NO-FEAR Airlines) with and without therapist guidance: a randomized controlled trial.
Campos, D, Bretón-López, J, Botella, C, Mira, A, Castilla, D, Mor, S, Baños, R, Quero, S
BMC psychiatry. 2019;(1):86
Abstract
BACKGROUND Internet-based treatments appear to be a promising way to enhance the in vivo exposure approach, specifically in terms of acceptability and access to treatment. However, the literature on specific phobias is scarce, and, as far as we know, there are no studies on Flying Phobia (FP). This study aims to investigate the effectiveness of an Internet-based exposure treatment for FP (NO-FEAR Airlines) that includes exposure scenarios composed of images and sounds, versus a waiting-list control group. A secondary aim is to explore two ways of delivering NO-FEAR Airlines, with and without therapist guidance. METHODS A randomized controlled trial (RCT) was conducted in which 69 participants were allocated to: 1) NO-FEAR Airlines totally self-applied, 2) NO-FEAR Airlines with therapist guidance, 3) a waiting-list control group. Primary outcome measures were the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes included the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Behavioral outcomes (post-treatment flights and safety behaviors) were also included. Mixed-model analyses with no ad hoc imputations were conducted for primary and secondary outcome measures. RESULTS NO-FEAR Airlines (with and without therapist guidance) was significantly effective, compared to the waiting list control group, on all primary and secondary outcomes (all ps < .05), and no significant differences were found between the two ways of delivering the intervention. Significant improvements on diagnostic status and reliable change indexes were also found in both treatment groups at post-treatment. Regarding behavioral outcomes, significant differences in safety behaviors were found at post-treatment, compared to the waiting list. Treatment gains were maintained at 3- and 12-month follow-ups. CONCLUSION FP can be treated effectively via the Internet. NO-FEAR Airlines helps to enhance the exposure technique and provide access to evidence-based psychological treatment to more people in need. These data are congruent with previous studies highlighting the usefulness of computer-assisted exposure programs for FP, and they contribute to the literature on Internet-based interventions. To the best of our knowledge, this is the first RCT to investigate the effectiveness of an Internet-based treatment for FP and explore two ways of delivering the intervention (with and without therapist guidance). TRIAL REGISTRATION Clinicaltrials.gov: NCT02298478 ( https://clinicaltrials.gov/ct2/show/NCT02298478 ). Trial registration date 3 November 2014.
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Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study.
Wittleder, S, Ajenikoko, A, Bouwman, D, Fang, Y, McKee, MD, Meissner, P, Orstad, SL, Rehm, CD, Sherman, SE, Smith, S, et al
Contemporary clinical trials. 2019;:37-45
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Abstract
INTRODUCTION Over one-third of American adults have obesity with increased risk of chronic disease. Primary care providers often do not counsel patients about weight management due to barriers such as lack of time and training. To address this problem, we developed a technology-assisted health coaching intervention called Goals for Eating and Moving (GEM) to facilitate obesity counseling within the patient-centered medical home (PCMH) model of primary care. The objective of this paper is to describe the rationale and design of a cluster-randomized controlled trial to test the GEM intervention when compared to Enhanced Usual Care (EUC). METHOD We have randomized 19 PCMH teams from two NYC healthcare systems (VA New York Harbor Healthcare System and Montefiore Medical Group practices) to either the GEM intervention or EUC. Eligible participants are English and Spanish-speaking primary care patients (ages 18-69 years) with obesity or who are overweight with comorbidity (e.g., arthritis, sleep apnea, hypertension). The GEM intervention consists of a tablet-delivered goal setting tool, a health coaching visit and twelve telephone calls for patients, and provider counseling training. Patients in the EUC arm receive health education materials. The primary outcome is mean weight loss at 1 year. Secondary outcomes include changes in waist circumference, diet, and physical activity. We will also examine the impact of GEM on obesity-related provider counseling competency and attitudes. CONCLUSION If GEM is found to be efficacious, it could provide a structured approach for improving weight management for diverse primary care patient populations with elevated cardiovascular disease risk.
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A novel prescription pedometer-assisted walking intervention and weight management for Chinese occupational population.
Yu, Y, Lv, Y, Yao, B, Duan, L, Zhang, X, Xie, L, Chang, C
PloS one. 2018;(1):e0190848
Abstract
BACKGROUND AND AIM Information technology has been previously used for the research and practice of health promotion. Appropriate and effective health promotion methods used by professional groups remain to be investigated. This study aimed to assess the feasibility and effectiveness of a weight management program among the Chinese occupational population using and a novel information technology exercise prescription. STUDY DESIGN AND PARTICIPANTS A 3-month open, self-monitored intervention trial, involving individualized pedometer-assisted exercise prescription and a one-time targeted dietary guidance prior to exercise was conducted on the Chinese occupational population aged 18-65 years in China from 2015 to 2016. Data were collected from March 2015 to May 2016 and analyzed from June 2016 to August 2016. Participants were also asked to synchronize exercise data of the pedometer to the Internet-based Health System Center daily (at least weekly), by connecting to the personal computer (PC) using a USB cable or via Bluetooth. RESULTS Eligible participants included 802 Chinese occupational persons, and 718 of them followed exercise interventions with 89.5% (718/802) adherence to the exercise programs. Of them, 688 participants completed the program with 85.8% (688/802) adherence to the exercise program and their data were analyzed. Weight decreased by 2.2% among all overweight/obese participants, with 1.8% reduction in waist circumference and 3.3% reduction in body fat percentage (p< 0.001). Weight and body fat percentage in normal-weight individuals decreased by 0.7% and 2.5%, respectively (p < 0.01). A weight gain of 1.0% was observed in all underweight participants (p< 0.05), and 68.2% (208/305) of overweight/obese participants experienced weight loss, with an average reduction of 3.5%, with 20.2% (42/208) of them achieving weight loss ≥5%. Blood pressure and fasting serum glucose decreased significantly in both the overweight/obese and the normal-weight individuals (p < 0.05). The incidence of hypertension was significantly lower and lifestyle behavior significantly improved (p < 0.05). CONCLUSION The prescription pedometer-assisted walking intervention can effectively improve exercise adherence and manage weight. This approach was also effective in controlling the risk factors of weight-related chronic diseases. TRIAL REGISTRATION Chinese Clinical Trial Registry (ChiCTR) ChiCTR-OOh-16010229.
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The effectiveness of ICT-based neurocognitive and psychosocial rehabilitation programmes in people with mild dementia and mild cognitive impairment using GRADIOR and ehcoBUTLER: study protocol for a randomised controlled trial.
Vanova, M, Irazoki, E, García-Casal, JA, Martínez-Abad, F, Botella, C, Shiells, KR, Franco-Martín, MA
Trials. 2018;(1):100
Abstract
BACKGROUND Cognitive rehabilitation is a highly individualised, non-pharmacological intervention for people with mild cognitive impairment (MCI) and dementia, which in recent years has also been developed for various IT platforms. METHODS In this study, we aim to evaluate the effectiveness of the cognitive rehabilitation software GRADIOR in a multi-centre, single-blinded randomised controlled trial with people with MCI and mild dementia. A total of 400 people with MCI and mild dementia will be randomly allocated to one of four groups. This trial will compare the cognitive rehabilitation treatment using the GRADIOR programme with a psychosocial stimulation intervention (PSS) using the ehcoBUTLER platform, with a combined treatment consisting of GRADIOR and ehcoBUTLER, and with a group receiving treatment as usual during a period of 1 year. DISCUSSION The outcomes of this clinical trial will be to determine any relevant changes in cognition, mood, quality of life, activities of daily living and quality of patient-carer relationship after 4 months and 1 year of intervention in a cross-sectional group comparison. Participants will be followed-up for 1 year to investigate potential long-term effects of the conducted treatments. TRIAL REGISTRATION Current Controlled Trials ISRCTN, ID: 15742788 . Registered on 12 June 2017.
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Mediterranean Diet Adherence and Genetic Background Roles within a Web-Based Nutritional Intervention: The Food4Me Study.
San-Cristobal, R, Navas-Carretero, S, Livingstone, KM, Celis-Morales, C, Macready, AL, Fallaize, R, O'Donovan, CB, Lambrinou, CP, Moschonis, G, Marsaux, CFM, et al
Nutrients. 2017;(10)
Abstract
Mediterranean Diet (MedDiet) adherence has been proven to produce numerous health benefits. In addition, nutrigenetic studies have explained some individual variations in the response to specific dietary patterns. The present research aimed to explore associations and potential interactions between MedDiet adherence and genetic background throughout the Food4Me web-based nutritional intervention. Dietary, anthropometrical and biochemical data from volunteers of the Food4Me study were collected at baseline and after 6 months. Several genetic variants related to metabolic risk features were also analysed. A Genetic Risk Score (GRS) was derived from risk alleles and a Mediterranean Diet Score (MDS), based on validated food intake data, was estimated. At baseline, there were no interactions between GRS and MDS categories for metabolic traits. Linear mixed model repeated measures analyses showed a significantly greater decrease in total cholesterol in participants with a low GRS after a 6-month period, compared to those with a high GRS. Meanwhile, a high baseline MDS was associated with greater decreases in Body Mass Index (BMI), waist circumference and glucose. There also was a significant interaction between GRS and the MedDiet after the follow-up period. Among subjects with a high GRS, those with a high MDS evidenced a highly significant reduction in total carotenoids, while among those with a low GRS, there was no difference associated with MDS levels. These results suggest that a higher MedDiet adherence induces beneficial effects on metabolic outcomes, which can be affected by the genetic background in some specific markers.
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Do images of a personalised future body shape help with weight loss? A randomised controlled study.
Ossolinski, G, Jiwa, M, McManus, A, Parsons, R
Trials. 2017;(1):180
Abstract
BACKGROUND This randomised controlled study evaluated a computer-generated future self-image as a personalised, visual motivational tool for weight loss in adults. METHODS One hundred and forty-five people (age 18-79 years) with a Body Mass Index (BMI) of at least 25 kg/m2 were randomised to receive a hard copy future self-image at recruitment (early image) or after 8 weeks (delayed image). Participants received general healthy lifestyle information at recruitment and were weighed at 4-weekly intervals for 24 weeks. The image was created using an iPad app called 'Future Me'. A second randomisation at 16 weeks allocated either an additional future self-image or no additional image. RESULTS Seventy-four participants were allocated to receive their image at commencement, and 71 to the delayed-image group. Regarding to weight loss, the delayed-image group did consistently better in all analyses. Twenty-four recruits were deemed non-starters, comprising 15 (21%) in the delayed-image group and 9 (12%) in the early-image group (χ2(1) = 2.1, p = 0.15). At 24 weeks there was a significant change in weight overall (p < 0.0001), and a difference in rate of change between groups (delayed-image group: -0.60 kg, early-image group: -0.42 kg, p = 0.01). Men lost weight faster than women. The group into which participants were allocated at week 16 (second image or not) appeared not to influence the outcome (p = 0.31). Analysis of all completers and withdrawals showed a strong trend over time (p < 0.0001), and a difference in rate of change between groups (delayed-image: -0.50 kg, early-image: -0.27 kg, p = 0.0008). CONCLUSION One in five participants in the delayed-image group completing the 24-week intervention achieved a clinically significant weight loss, having received only future self-images and general lifestyle advice. Timing the provision of future self-images appears to be significant, and promising for future research to clarify their efficacy. TRIAL REGISTRATION Australian Clinical Trials Registry, identifier: ACTRN12613000883718 . Registered on 8 August 2013.
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Internet-Delivered Cognitive Behavior Therapy for Adolescents With Irritable Bowel Syndrome: A Randomized Controlled Trial.
Bonnert, M, Olén, O, Lalouni, M, Benninga, MA, Bottai, M, Engelbrektsson, J, Hedman, E, Lenhard, F, Melin, B, Simrén, M, et al
The American journal of gastroenterology. 2017;(1):152-162
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OBJECTIVES Few treatments have been able to effectively manage pediatric irritable bowel syndrome (IBS). Internet-delivered cognitive behavior therapy (Internet-CBT) based on exposure for abdominal symptoms is effective for adult IBS. The objective of this study was to evaluate the efficacy of Internet-CBT based on behavioral exposure for adolescents with IBS. METHODS Adolescents with IBS fulfilling the Rome III criteria were randomized to either Internet-CBT or a wait-list control. The Internet-CBT was a 10-week intervention where the main component was exposure to IBS symptoms by reduction of avoidance of abdominal symptoms and instead stepwise provocation of symptoms. The primary outcome was total score on Gastrointestinal Symptoms Rating Scale for IBS (GSRS-IBS). Secondary outcomes included adolescent- and parent-rated quality of life and parent-rated gastrointestinal symptoms. Difference between groups was assessed from pretreatment to posttreatment and the Internet-CBT group was also evaluated at 6 months after treatment completion. RESULTS A total of 101 adolescents with IBS (13-17 years of age) were included in this study. Dropout rates were low (6%) and all randomized patients were included in intent-to-treat analyses based on mixed effects models. Analyses showed a significant larger pretreatment to posttreatment change on the primary outcome GSRS-IBS (B=-6.42, P=0.006, effect size Cohen's d=0.45, 95% confidence interval (0.12, 0.77)) and on almost all secondary outcomes for the Internet-CBT group compared with the control group. After 6 months, the results were stable or significantly improved. CONCLUSIONS Internet-CBT based on exposure exercises for adolescents with IBS can effectively improve gastrointestinal symptoms and quality of life.
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Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial.
Norton, C, Emmanuel, A, Stevens, N, Scott, SM, Grossi, U, Bannister, S, Eldridge, S, Mason, JM, Knowles, CH
Trials. 2017;(1):139
Abstract
BACKGROUND Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1-2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significant impact on quality of life. There is uncertainty about the value of specialist investigations and whether equipment-intensive therapies using biofeedback confer additional benefit when compared with specialist conservative advice. METHODS/DESIGN A three-arm, parallel-group, multicentre randomised controlled trial. OBJECTIVES to determine whether standardised specialist-led habit training plus pelvic floor retraining using computerised biofeedback is more clinically effective than standardised specialist-led habit training alone; to determine whether outcomes are improved by stratification based on prior investigation of anorectal and colonic pathophysiology. Primary outcome measure is response to treatment, defined as a 0.4-point (10% of scale) or greater reduction in Patient Assessment of Constipation-Quality of Life (PAC-QOL) score 6 months after the end of treatment. Other outcomes up to 12 months include symptoms, quality of life, health economics, psychological health and qualitative experience. HYPOTHESES (1) habit training (HT) with computer-assisted direct visual biofeedback (HTBF) results in an average reduction in PAC-QOL score of 0.4 points at 6 months compared to HT alone in unselected adults with CC, (2) stratification to either HT or HTBF informed by pathophysiological investigation (INVEST) results in an average 0.4-point reduction in PAC-QOL score at 6 months compared with treatment not directed by investigations (No-INVEST). Inclusion: chronic constipation in adults (aged 18-70 years) defined by self-reported symptom duration of more than 6 months; failure of previous laxatives or prokinetics and diet and lifestyle modifications. Consenting participants (n = 394) will be randomised to one of three arms in an allocation ratio of 3:3:2: [1] habit training, [2] habit training and biofeedback or [3] investigation-led allocation to one of these arms. Analysis will be on an intention-to-treat basis. DISCUSSION This trial has the potential to answer some of the major outstanding questions in the management of chronic constipation, including whether costly invasive tests are warranted and whether computer-assisted direct visual biofeedback confers additional benefit to well-managed specialist advice alone. TRIAL REGISTRATION International Standard Randomised Controlled Trial Number: ISRCTN11791740. Registered on 16 July 2015.
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Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial.
Díaz-García, A, González-Robles, A, Fernández-Álvarez, J, García-Palacios, A, Baños, RM, Botella, C
BMC psychiatry. 2017;(1):145
Abstract
BACKGROUND Emotional disorders (ED) are among the most prevalent mental disorders. However, less than 50% of people suffering from ED receive the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which tries to address the underlying processes common to ED. Most of these programs focus primarily on down-regulating negative affectivity, rather than increasing strengths and up-regulating positive affectivity. The data suggest the existence of disturbances in positive affectivity in these disorders, and so new interventions focusing on these problems are greatly needed. It is also essential to provide assistance to all the people in need. Information and Communication Technologies can be very useful. This study aims to evaluate the efficacy of a transdiagnostic Internet-based treatment for ED in a community sample. The protocol includes traditional CBT components, as well as a specific component to address positive affect. We intend to test this protocol, including this specific component or not, versus a waiting list control group. Moreover, we aim to test the differential effect of this specific component, and study the effectiveness (in terms of patients' acceptance) of using a self-applied Internet-based program. This paper presents the study protocol. METHODS The study is a randomized controlled trial. 207 participants will be randomly assigned to: a)Transdiagnostic Internet-based protocol (TIBP), b)Transdiagnostic Internet-based protocol + positive affect component (TIBP + PA), or c)a Waiting List control group (WL). Primary outcomes measures will be the BDI-II, the BAI, and the PANAS. Secondary outcomes will include diagnosis-specific measures of the principal disorder. Participants' treatment acceptance will also be measured. Participants will be assessed at pre-, post-treatment, and 3- and 12- month follow-ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed. DISCUSSION To the best of our knowledge, this is the first study of a transdiagnostic Internet-based treatment for ED with a specific component to up-regulate positive affectivity. This intervention could contribute to improve the efficiency and effectiveness of current treatment programs for ED, promote the dissemination of EBTs, and help to decrease the high prevalence of ED. TRIAL REGISTRATION ClinicalTrial.gov: NCT02578758 . Registered 15 October 2015.
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Web-Based Interventions Targeting Cardiovascular Risk Factors in Middle-Aged and Older People: A Systematic Review and Meta-Analysis.
Beishuizen, CR, Stephan, BC, van Gool, WA, Brayne, C, Peters, RJ, Andrieu, S, Kivipelto, M, Soininen, H, Busschers, WB, Moll van Charante, EP, et al
Journal of medical Internet research. 2016;(3):e55
Abstract
BACKGROUND Web-based interventions can improve single cardiovascular risk factors in adult populations. In view of global aging and the associated increasing burden of cardiovascular disease, older people form an important target population as well. OBJECTIVE In this systematic review and meta-analysis, we evaluated whether Web-based interventions for cardiovascular risk factor management reduce the risk of cardiovascular disease in older people. METHODS Embase, Medline, Cochrane and CINAHL were systematically searched from January 1995 to November 2014. Search terms included cardiovascular risk factors and diseases (specified), Web-based interventions (and synonyms) and randomized controlled trial. Two authors independently performed study selection, data-extraction and risk of bias assessment. In a meta-analysis, outcomes regarding treatment effects on cardiovascular risk factors (blood pressure, glycated hemoglobin A1c (HbA1C), low-density lipoprotein (LDL) cholesterol, smoking status, weight and physical inactivity) and incident cardiovascular disease were pooled with random effects models. RESULTS A total of 57 studies (N=19,862) fulfilled eligibility criteria and 47 studies contributed to the meta-analysis. A significant reduction in systolic blood pressure (mean difference -2.66 mmHg, 95% CI -3.81 to -1.52), diastolic blood pressure (mean difference -1.26 mmHg, 95% CI -1.92 to -0.60), HbA1c level (mean difference -0.13%, 95% CI -0.22 to -0.05), LDL cholesterol level (mean difference -2.18 mg/dL, 95% CI -3.96 to -0.41), weight (mean difference -1.34 kg, 95% CI -1.91 to -0.77), and an increase of physical activity (standardized mean difference 0.25, 95% CI 0.10-0.39) in the Web-based intervention group was found. The observed effects were more pronounced in studies with short (<12 months) follow-up and studies that combined the Internet application with human support (blended care). No difference in incident cardiovascular disease was found between groups (6 studies). CONCLUSIONS Web-based interventions have the potential to improve the cardiovascular risk profile of older people, but the effects are modest and decline with time. Currently, there is insufficient evidence for an effect on incident cardiovascular disease. A focus on long-term effects, clinical endpoints, and strategies to increase sustainability of treatment effects is recommended for future studies.