Authorship Correction: A Clinician-Controlled Just-in-time Adaptive Intervention System (CBT+) Designed to Promote Acquisition and Utilization of Cognitive Behavioral Therapy Skills in Bulimia Nervosa: Development and Preliminary Evaluation Study

Juarascio, Adrienne S.; Srivastava, Paakhi; Presseller, Emily K; Clark, Kelsey E.; Manasse, Stephanie M.; Forman, Evan M.

doi:10.2196/31964

Cited by 1 publication

(4 citation statements)

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“…An EMI system comprising both the trEATsmart app and also a web-based portal through which study therapists have access to patients’ app entries was selected for its practical design, personalisation, mechanism-oriented set-up and scalability 54 55. The app development was based on a self-help app for the obesity-associated binge-eating disorder and an EMI system for obesity,41 47 56 which then led to the development of the app with EMI system for adjunctive use in cognitive-behavioural therapy (CBT) for bulimia nervosa 54 55. In an ongoing RCT, the app was translated into German and adapted to the adjunctive use in CBT of binge-eating disorder (DRKS00024597; www.drks.de).…”

Section: Methods and Analysismentioning

confidence: 99%

“…If (S)AEs will require additional or follow-up care, patients will be referred to the IFB Outpatient Unit or other local healthcare providers for psychological or medical treatment. Although SAEs have never been reported in comparable treatment trials,50 54 55 a special insurance will cover any potential risks for the patients caused by study-specific procedures.…”

Section: Methodsmentioning

confidence: 99%

“…Because of the preliminary nature of this exploratory trial, the single-centre design and the well-established safety of BWL treatment28 75 and smartphone-based interventions39 42–44 54–56 focusing on weight management skills, but not on psychopathology, an external Data Safety and Monitoring Board was not deemed to be necessary. Instead, the PI, an external collaborator and expert specialising in the smartphone app and BWL treatment (AJ), and a Biometrician (DP) will regularly monitor and supervise progress of the trial (including data safety and main endpoints).…”

Section: Methodsmentioning

confidence: 99%

“…An EMI system comprising both the trEATsmart app and also a web-based portal through which study therapists have access to patients' app entries was selected for its practical design, personalisation, mechanism-oriented set-up and scalability. 54 55 The app development was based on a self-help app for the obesity-associated binge-eating disorder and an EMI system for obesity, 41 47 56 Fertile women (within 2 years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy), 78 while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial device on contraception). Psychological/mental or other inabilities to supply required informed consent.…”

Section: Experimental Intervention-smartphone-supported Bwl Treatmentmentioning

confidence: 99%

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Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL)

et al. 2023

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IntroductionBehavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m2or ≥35.0 kg/m2with obesity-related comorbidity), leading to moderate weight loss which often cannot be maintained in the long term. Because weight loss depends on patients’ use of weight management skills, it is important to support them in daily life. In an ecological momentary intervention design, this clinical trial aims to adapt, refine and evaluate a personalised cognitive-behavioural smartphone application (app) in BWL treatment to foster patients’ weight management skills use in everyday life. It is hypothesised that using the app is feasible and acceptable, improves weight loss and increases skills use and well-being.Methods and analysisIn the pilot phase, the app will be adapted, piloted and optimised for BWL treatment following a participatory patient-oriented approach. In the subsequent single-centre, assessor-blind, exploratory randomised controlled trial, 90 adults with SO will be randomised to BWL treatment over 6 months with versus without adjunctive app. Primary outcome is the amount of weight loss (kg) at post-treatment (6 months), compared with pretreatment, derived from measured body weight. Secondary outcomes encompass feasibility, acceptance, weight management skills use, well-being and anthropometrics assessed at pretreatment, midtreatment (3 months), post-treatment (6 months) and 6-month follow-up (12 months). An intent-to-treat linear model with randomisation arm, pretreatment weight and stratification variables as covariates will serve to compare arms regarding weight at post-treatment. Secondary analyses will include linear mixed models, generalised linear models and regression and mediation analyses. For safety analysis (serious) adverse events will be analysed descriptively.Ethics and disseminationThe study was approved by the Ethics Committee of the University of Leipzig (DE-21-00013674) and notified to the Federal Institute for Drugs and Medical Devices. Study results will be disseminated through peer-reviewed publications.RegistrationThis study was registered at the German Clinical Trials Register (DRKS00026018), www.drks.de.Trial registration numberDRKS00026018

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Section: Methods and Analysismentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%