Dataset Information

Applying a web-based self-help intervention for bulimia nervosa in routine care: Study protocol for a randomized controlled trial.

ABSTRACT:

Background

Individuals with bulimia nervosa (BN) experience persistent episodes of binge eating and inappropriate compensatory behavior associated with impaired physical and mental health. Despite the existence of effective treatments, many individuals with BN remain untreated, leading to a high burden and an increased risk of chronicity. Web-based interventions may help facilitate access to evidence-based treatments for BN by reducing barriers to the health care system.

Methods

The present study will investigate the effectiveness of a web-based self-help intervention for BN in a two-armed randomized controlled trial. Individuals diagnosed with BN (N = 152) will be randomly assigned to either (1) an intervention group receiving a 12-week web-based intervention or (2) a waitlist control group with delayed access to the intervention. Further assessments will be scheduled 6 (mid-treatment) and 12 (post-treatment) weeks after baseline. Changes in the number of binge eating episodes and compensatory behaviors will be examined as primary outcomes. Secondary outcomes include global eating pathology, functional impairments, well-being, comorbid psychopathology, self-esteem, and emotion regulation abilities.

Discussion

Adding web-based interventions into routine care is a promising approach to overcome the existing treatment gap for patients with BN. Therefore, the current study will test the effectiveness of a web-based intervention for BN under standard clinical care settings.

Trial registration

ClinicalTrials.gov, Identifier: NCT04876196 (registered on May 6th, 2021).

SUBMITTER: Hartmann S

PROVIDER: S-EPMC8894237 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Applying a web-based self-help intervention for bulimia nervosa in routine care: Study protocol for a randomized controlled trial.

Hartmann Steffen S Pruessner Luise L Rubel Julian A JA Lalk Christopher C Barnow Sven S Timm Christina C

Internet interventions 20220217

<h4>Background</h4>Individuals with bulimia nervosa (BN) experience persistent episodes of binge eating and inappropriate compensatory behavior associated with impaired physical and mental health. Despite the existence of effective treatments, many individuals with BN remain untreated, leading to a high burden and an increased risk of chronicity. Web-based interventions may help facilitate access to evidence-based treatments for BN by reducing barriers to the health care system.<h4>Methods</h4>T ...[more]

PMID: 35251938

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Project description:ImportanceDespite the existence of effective treatments, many individuals with bulimia nervosa (BN) do not receive evidence-based therapies. Integrating digital interventions into routine care might reach more patients and reduce the clinical burden of BN.ObjectiveTo evaluate the effectiveness of a web-based cognitive behavioral self-help intervention for individuals with BN.Design, setting, and participantsA 2-group randomized clinical trial without follow-up was conducted between February 2, 2021, and July 9, 2022, in Germany. Participants aged between 18 and 65 years who met the diagnostic criteria for BN were enrolled online via self-referral. Data analyses were conducted from October 24, 2022, to December 23, 2023.InterventionsA web-based cognitive behavioral self-help intervention including 12 weekly modules was compared with a waiting-list control group only having access to routine care.Main outcomes and measuresThe primary outcome was the change in the number of bulimic episodes between baseline and posttreatment. Secondary outcomes included changes in global eating disorder symptoms, clinical impairment, well-being, work capacity, comorbid symptoms, self-esteem, and emotion regulation complemented by weekly measures and ecological momentary assessment. Intention-to-treat analyses were performed.ResultsParticipants (N = 154; mean [SD] age, 29.6 [8.6] years; 149 [96.8%] female) receiving the web-based intervention demonstrated a significantly greater decrease in bulimic episodes compared with the control group (Cohen d = -0.48; 95% CI, -0.75 to -0.20; P < .001), representing a significant change in binge-eating episodes (Cohen d = -0.61; 95% CI, -0.89 to -0.33; P < .001), but not in compensatory behaviors (Cohen d = -0.25; 95% CI, -0.51 to 0.02; P = .21). The intervention was superior in improving global eating disorder symptoms (Cohen d = -0.61; 95% CI, -0.89 to -0.32; P < .001) and clinical impairment (Cohen d = -0.62; 95% CI, -0.92 to -0.33; P < .001). No significant effects were found for well-being (Cohen d = -0.08; 95% CI, -0.37 to 0.22; P > .99) and work capacity (Cohen d = -0.01; 95% CI, -0.68 to 0.66; P = .99). Exploratory analyses indicated significant changes in self-esteem and emotion regulation difficulties, but not in comorbid symptoms.Conclusions and relevanceIn this randomized clinical trial, a web-based cognitive behavioral self-help intervention effectively decreased eating disorder symptoms and illness-related burden in individuals with BN, underlining the potential of digital interventions to complement established treatments.Trial registrationClinicalTrials.gov Identifier: NCT04876196.

Project description:BackgroundRelapse rates in bulimia nervosa (BN) are high even after successful treatment, but patients often hesitate to take up further treatment. An easily accessible program might help maintain treatment gains. Encouraged by the effects of Web-based eating disorder prevention programs, we developed a manualized, Web-based aftercare program (IN@) for women with BN following inpatient treatment.ObjectiveThe objective of this study was to determine the efficacy of the web-based guided, 9-month, cognitive-behavioral aftercare program IN@ for women with BN following inpatient treatment.MethodsWe conducted a randomized controlled efficacy trial in 253 women with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) BN and compared the results of IN@ with treatment as usual (TAU). Assessments were carried out at hospital admission (T0), hospital discharge/baseline (T1), postintervention (T2; 9 months after baseline), 9-month follow-up (T3; 18 months after baseline). The primary outcome, abstinence from binge eating and compensatory behaviors during the 2 months preceding T2, was analyzed by intention to treat, using logistic regression analyses. Frequencies of binge eating and vomiting episodes, and episodes of all compensatory behaviors were analyzed using mixed effects models.ResultsAt T2, data from 167 women were available. There were no significant differences in abstinence rates between the TAU group (n=24, 18.9%) and the IN@ group (n=27, 21.4%; odds ratio, OR=1.29; P=.44). The frequency of vomiting episodes in the IN@ group was significantly (46%) lower than in the TAU group (P=.003). Moderator analyses revealed that both at T2 and T3, women of the intervention group who still reported binge eating and compensatory behaviors after inpatient treatment benefited from IN@, whereas women who were already abstinent after the inpatient treatment did not (P=.004; P=.002). Additional treatment utilization was high in both groups between baseline and follow-up.ConclusionsOverall, data from this study suggest moderate effects of IN@. High rates of outpatient treatment utilization after inpatient treatment may have obscured potential intervention effects on abstinence. An aftercare intervention might be more beneficial as part of a stepped-care approach.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 08870215; http://www.isrctn.com/ISRCTN08870215 (Archived by WebCite at http://www.webcitation.org/6soA5bIit).

Project description:BackgroundA substantial rate of patients with bulimia nervosa (BN) also suffer from Borderline personality disorder (BN + BPD). It is widely unknown how these comorbid patients with BN + BPD present and respond to inpatient treatment. Aims of the study were to examine (1) specific characteristics of patients with BN + BPD at admission, discharge, and during treatment, and (2) differential effects of inpatient treatment for BN vs. BN + BPD.MethodWe analyzed routine data of inpatients admitted for the treatment of BN between 2013 and 2017 in a specialized hospital for eating disorders. (1) Cross-sectional differences were examined with independent t-tests and χ2-tests; and (2) treatment effects pertaining to eating disorders symptoms, depression, psychosocial functioning and general psychopathology with repeated measures analysis of variance.ResultsOf 1298 inpatients (96% female), 13.2% also had a diagnosis of BPD. (1) Patients with BN + BPD had more previous inpatient treatments (p = 0.001), had a longer length of stay (p = 0.003), gained more weight during treatment (p = 0.006), and were more often irregularly discharged (p = 0.018) as well as rated as unfit to work at discharge (p = 0.003). (2) Both groups improved in all examined variables (all main effects treatment p < 0.001). Patients with BN + BPD showed worse symptoms aggregated across admission and discharge (all main effects diagnosis p < 0.05). Patients with BN + BPD showed smaller improvements (interaction treatment×discharge) in depressive symptoms (p = 0.018), perfectionism (p = 0.009), and asceticism (p = 0.035) and discharge scores mostly lay in the range of the admission scores of the BN-only group.ConclusionPatients with BN + BPD improve during intense and specialized inpatient treatment, yet, retain pronounced impairment at discharge despite longer treatment. Treatment needs to be improved and should focus on transdiagnostic symptoms of BN and BPD.

Project description:IntroductionLow back pain (LBP) and neck pain (NP) are common and costly conditions. Self-management is a key element in the care of persistent LBP and NP. Artificial intelligence can be used to support and tailor self-management interventions, but their effectiveness needs to be ascertained. The aims of this trial are (1) to evaluate the effectiveness of an individually tailored app-based self-management intervention (selfBACK) adjunct to usual care in people with LBP and/or NP in secondary care compared with usual care only, and (2) to compare the effectiveness of selfBACK with a web-based self-management intervention without individual tailoring (e-Help).Methods and analysisThis is a randomised, assessor-blind clinical trial with three parallel arms: (1) selfBACK app adjunct to usual care; (2) e-Help website adjunct to usual care and (3) usual care only. Patients referred to St Olavs Hospital, Trondheim (Norway) with LBP and/or NP and accepted for assessment/treatment at the multidisciplinary outpatient clinic for back or neck rehabilitation are invited to the study. Eligible and consenting participants are randomised to one of the three arms with equal allocation ratio. We aim to include 279 participants (93 in each arm). Outcome variables are assessed at baseline (before randomisation) and at 6-week, 3-month and 6-month follow-up. The primary outcome is musculoskeletal health measured by the Musculoskeletal Health Questionnaire at 3 months. A mixed-methods process evaluation will document patients' and clinicians' experiences with the interventions. A health economic evaluation will estimate the cost-effectiveness of both interventions' adjunct to usual care.Ethics and disseminationThe trial is approved by the Regional Committee for Medical and Health Research Ethics in Central Norway (Ref. 2019/64084). The results of the trial will be published in peer-review journals and presentations at national and international conferences relevant to this topic.Trial registration numberNCT04463043.

Dataset Information

Applying a web-based self-help intervention for bulimia nervosa in routine care: Study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Applying a web-based self-help intervention for bulimia nervosa in routine care: Study protocol for a randomized controlled trial.

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