Self-Help And Recovery guide for Eating Disorders (SHARED): study protocol for a randomized controlled trial.
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SUBMITTER: Cardi V
PROVIDER: S-EPMC4435653 | biostudies-literature | 2015 Apr
REPOSITORIES: biostudies-literature
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Self-Help And Recovery guide for Eating Disorders (SHARED): study protocol for a randomized controlled trial.
Cardi Valentina V Ambwani Suman S Crosby Ross R Macdonald Pamela P Todd Gill G Park Jinhong J Moss Sara S Schmidt Ulrike U Treasure Janet J
Trials 20150416
<h4>Background</h4>We describe the theoretical rationale and protocol for Self-Help And Recovery guide for Eating Disorders (SHARED), a trial investigating whether a guided self-care intervention (Recovery MANTRA) is a useful addition to treatment as usual for individuals with anorexia nervosa. Recovery MANTRA, a 6-week self-care intervention supplemented by peer mentorship, is a module extension of the Maudsley Model of Treatment for Adults with Anorexia Nervosa and targets the maintenance fact ...[more]
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Project description:ObjectiveGuided self-help treatments based on cognitive-behavior therapy (CBT-GSH) are efficacious for binge eating. With limited availability of CBT-GSH in the community, mobile technology offers a means to increase use of these interventions. The purpose of this study was to test the initial efficacy of Noom Monitor, a smartphone application designed to facilitate CBT-GSH (CBT-GSH + Noom), on study retention, adherence, and eating disorder symptoms compared to traditional CBT-GSH.MethodSixty-six men and women with DSM-5 binge-eating disorder (BED) or bulimia nervosa (BN) were randomized to receive eight sessions of CBT-GSH + Noom (n = 33) or CBT-GSH (n = 33) over 12 weeks. Primary symptom outcomes were eating disorder examination objective bulimic episodes (OBEs), subjective bulimic episodes (SBEs), and compensatory behaviors. Assessments were collected at 0, 4, 8, 12, 24, and 36 weeks. Behavioral outcomes were modeled using zero-inflated negative-binomial latent growth curve models with intent-to-treat.ResultsThere was a significant effect of treatment on change in OBEs (β = -0.84, 95% CI = -1.49, -0.19) favoring CBT-GSH + Noom. Remission rates were not statistically different between treatments for OBEs (βlogit = -0.73, 95% CI = -1.86, 3.27; CBT-GSH-Noom = 17/27, 63.0% vs. CBT-GSH 11/27, 40.7%, NNT = 4.5), but CBT-GSH-Noom participants reported greater meal and snack adherence and regular meal adherence mediated treatment effects on OBEs. The treatments did not differ at the 6-month follow-up.DiscussionSmartphone applications for the treatment binge eating appear to have advantages for adherence, a critical component of treatment dissemination.
| S-EPMC5755703 | biostudies-literature
Project description:BackgroundAviophobia (the fear of flying) can greatly impact the daily life functioning of people with the condition. Traditional exposure-based treatment is hampered by the limited availability of airplane practice situations, which is a result of economical and practical concerns. Easily accessible and low-cost virtual reality exposure therapy may address these challenges.ObjectiveThe purpose of our study is to investigate the effectiveness of ZeroPhobia: Aviophobia (a self-help mobile app-based treatment) in reducing flight anxiety symptoms and depressive and anxiety symptoms. We will also investigate the effects of usage intensity, the sense of immersion, inherent absorption ability, and perceived user-friendliness on the treatment effect.MethodsParticipants (N=114) who are aged 18-64 years and experience at least mild symptoms of aviophobia will be recruited from the general Dutch population and randomized into a treatment group or waitlist control group. By using their own phones and rudimentary mobile virtual reality headsets, participants will receive six modules of psychoeducation and cognitive behavioral therapy, which will include six levels of virtual reality exposure therapy over a period of 6 weeks. Assessments will be conducted at baseline, posttest (ie, after 6 weeks), and 3- and 12-month follow-ups. The primary outcome measure of our study is the Flight Anxiety Situations Questionnaire. The secondary outcome measures include anxiety and depression measures and additional covariates (including usage intensity, the degree of immersion, etc). We will test treatment effectiveness by conducting an intention-to-treat analysis and estimating average treatment effects on the treated. The mechanisms of treatment effect will also be explored.ResultsThe study was funded on September 25, 2018. Ethical approval was received on October 11, 2019. Recruitment closed on May 7, 2020.ConclusionsOur study will further the scientific understanding and clinical implications of technology's current ability to aid in providing effective, accessible treatment for the fear of flying.Trial registrationNetherlands Trial Registry NL70238.029.19; https://www.trialregister.nl/trial/8257.International registered report identifier (irrid)DERR1-10.2196/22008.
| S-EPMC8076993 | biostudies-literature
Project description:Background:There is limited evidence to inform nutrition and dietetic interventions for individuals with eating disorders even though it is recommended as an essential part of multidisciplinary management. There is minimal guidance, an absence of standardised nutrition educational material, and no research on how best to educate patients on healthy eating and how to achieve nutrition adequacy. Therefore the REAL Food Guide was developed. Methods:The REAL Food Guide is a pyramid with four layers and key nutrition messages beside each layer that was conceived to address gaps in nutrition education and intervention for individuals with eating disorders. Written and verbal consumer feedback was obtained from consumers receiving treatment regarding the acceptability and usefulness of the REAL Food Guide. A unique database was developed to reflect the types of foods and realistic portion sizes that patients are likely to select. This database was used for nutrition modelling to assess the nutrition adequacy of three meal patterns (meat containing, vegetarian and semi-vegan) for both weight maintenance and weight regain. Each meal pattern was compared to the Nutrient Reference Values for Australia and New Zealand. Results:Nutritional analysis demonstrated nutritional adequacy of meal patterns for energy, macronutrients and most micronutrients when the recommended number of serves from the REAL Food Guide were assessed. All meal patterns were adequate in micronutrients except for the semi-vegan meal pattern that was inadequate in vitamin D. Feedback from individuals with eating disorders demonstrates the nutrition education tool was acceptable to them as they felt it was more helpful for their recovery than general nutrition guidelines. Conclusion:The REAL Food Guide is a comprehensive and user-friendly guide that clinicians can use to educate patients about components of a balanced and healthy diet. The guide can educate all eating disorder clinicians, including those who are new to the field, about the basics of nutrition. Clinicians using the guide can be confident that, if followed, patient's energy and nutritional requirements will be met and important nutrition education messages are reinforced, that are tailored to the beliefs and concerns of individuals with eating disorders.
| S-EPMC5878939 | biostudies-literature
Project description:BackgroundOwing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy-enhanced (CBT-E) may have great advantages for patients if its efficacy can be established.ObjectiveThe aim of this study was to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition.MethodsA single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90, 50%) or the delayed-treatment control condition (n=90, 50%) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between- and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination-Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions.ResultsDuring the last 4 weeks of treatment, objective binges reduced from an average of 19 (SD 16) to 3 (SD 5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between the groups. Of the 180 participants, 142 (78.9%) completed treatment. The overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition.ConclusionsThis is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study's findings underscore the international guidelines recommending this type of treatment for binge eating disorder.Trial registrationNetherlands Trial Registry (NTR) NL7994; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7994.International registered report identifier (irrid)RR2-10.1186/s12888-020-02604-1.
| S-EPMC10186189 | biostudies-literature
Project description:BackgroundDepression is one of the most debilitating and costly mental disorders. There is increasing evidence for the efficacy of online self-help in alleviating depression. Knowledge regarding the options of combining online self-help with inpatient psychotherapy is still limited. Therefore, we plan to evaluate an evidence-based self-help program (deprexis®; Gaia AG, Hamburg, Germany) to improve the efficacy of inpatient psychotherapy and to maintain treatment effects in the aftercare period.Methods/designDepressed patients (n = 240) with private internet access aged between 18 and 65 are recruited during psychosomatic inpatient treatment. Participants are randomized to an intervention or control group at the beginning of inpatient treatment. The intervention group (n = 120) is offered an online self-help program with 12 weekly tasks, beginning during the inpatient treatment. The control group (n = 120) obtains access to an online platform with weekly updated information on depression for the same duration. Assessments are conducted at the beginning (T0) and the end of inpatient treatment (T1), at the end of intervention (T2) and 6 months after randomization (T3). The primary outcome is the depression score measured by the Beck Depression Inventory-II at T2. Secondary outcome measures include anxiety, self-esteem, quality of life, dysfunctional cognitions and work ability.DiscussionWe expect the intervention group to benefit from additional online self-help during inpatient psychotherapy and to maintain the benefits during follow-up. This could be an important approach to develop future concepts of inpatient psychotherapy.Trial registrationClinicalTrials.gov Identifier: NCT02196896 (registered on 16 July 2014).
| S-EPMC4376072 | biostudies-literature
Project description:Guided self-help is a recommended first-step treatment for bulimia nervosa, binge eating disorder and atypical variants of these disorders. Further research is needed to compare guided self-help that is delivered face-to-face versus via email.This clinical trial uses a randomised, controlled design to investigate the effectiveness of providing guided self-help either face-to-face or via e-mail, also using a delayed treatment control condition. At least 17 individuals are required per group, giving a minimum N of 51.Symptom outcomes will be assessed and estimates of cost-effectiveness made. Results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision. The trial has been approved by an ethics review board and was registered with ClinicalTrials.gov NCT01832792 on 9 April 2013.
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Project description:BackgroundSuicidal thoughts are common, causing distress for millions of people all over the world. However, people with suicidal thoughts might not access support due to financial restraints, stigma or a lack of available treatment offers. Self-help programs provided online could overcome these barriers, and previous efforts show promising results in terms of reducing suicidal thoughts. This study aims to examine the effectiveness of an online self-help intervention in reducing suicidal thoughts among people at risk of suicide. The Danish Self-help Online against Suicidal thoughts (SOS) trial is a partial replication of a previously conducted Dutch trial.Methods and designA randomized, waiting-list controlled trial with 1:1 allocation ratio will be carried out. A total of 438 people with suicidal thoughts will be recruited from the Danish suicide hotline, The Lifeline's, website and allocated to the intervention condition (N = 219) or the control condition (N = 219). The intervention condition consists of a 6-week, Internet-based self-help therapy intervention. The format of the intervention is self-help, but the participants can be guided by the trial manager. The control condition consists of a waiting-list assignment for 32 weeks. The primary outcomes are frequency and intensity of suicidal thoughts. Secondary outcome measures include depressive symptoms, hopelessness, worrying, quality of life, costs related to health care utilization and production loss. Number of deliberate self-harm episodes, suicides and deaths will, as well as the participant's evaluation of the intervention and the experience of negative effects, be investigated. Assessments will be conducted over the intervention website through self-report questionnaires at baseline, 2 weeks, 4 weeks, 6 weeks and 32 weeks (6 months post intervention).DiscussionIf we find the intervention to be linked to reductions in suicidal thoughts, this will strengthen the evidence that online self-help interventions are relevant tools for people with suicidal thoughts.Trial registrationClinicalTrials.gov, NCT02872610 . Registered on 9 August 2016.
| S-EPMC5273797 | biostudies-literature
Project description:BackgroundEating disorders severely impact psychological, physical, and social functioning, and yet, the majority of individuals with eating disorders do not receive treatment. Mobile health apps have the potential to decrease access barriers to care and reach individuals who have been underserved by traditional treatment modalities.ObjectiveThe objective of this study was to evaluate the effectiveness of a tailored, fully automated self-help version of Recovery Record, an app developed for eating disorders management. We examined differences in eating disorder symptom change in app users that were randomized to receive either a standard, cognitive behavioral therapy-based version of the app or a tailored version that included algorithmically determined clinical content aligned with baseline and evolving user eating disorder symptom profiles.MethodsParticipants were people with eating disorder symptoms who did not have access to traditional treatment options and were recruited via the open-access Recovery Record app to participate in this randomized controlled trial. We examined both continuous and categorical clinical improvement outcomes (measured with the self-report Eating Disorder Examination Questionnaire [EDE-Q]) in both intervention groups.ResultsBetween December 2016 and August 2018, 3294 Recovery Record app users were recruited into the study, out of which 959 were considered engaged, completed follow-up assessments, and were included in the analyses. Both study groups achieved significant overall outcome improvement, with 61.6% (180/292) of the tailored group and 55.4% (158/285) of the standard group achieving a clinically meaningful change in the EDE-Q, on average. There were no statistically significant differences between randomized groups for continuous outcomes, but a pattern of improvement being greater in the tailored group was evident. The rate of remission on the EDE-Q at 8 weeks was significantly greater in the group receiving the tailored version (d=0.22; P≤.001).ConclusionsThis is the first report to compare the relative efficacy of two versions of a mobile app for eating disorders. The data suggest that underserved individuals with eating disorder symptoms may benefit clinically from a self-help app and that personalizing app content to specific clinical presentations may be more effective in promoting symptomatic remission on the EDE-Q than content that offers a generic approach.Trial registrationClinicalTrials.gov NCT02503098; https://clinicaltrials.gov/ct2/show/NCT02503098.
| S-EPMC6895866 | biostudies-literature
Project description:ImportanceEating disorders (EDs) are common, serious psychiatric disorders on college campuses, yet most affected individuals do not receive treatment. Digital interventions have the potential to bridge this gap.ObjectiveTo determine whether a coached, digital, cognitive behavior therapy (CBT) intervention improves outcomes for college women with EDs compared with referral to usual care.Design, setting, and participantsThis cluster randomized trial was conducted from 2014 to 2018 at 27 US universities. Women with binge-purge EDs (with both threshold and subthreshold presentations) were recruited from enrolled universities. The 690 participants were followed up for up to 2 years after the intervention. Data analysis was performed from February to September 2019.InterventionsUniversities were randomized to the intervention, Student Bodies-Eating Disorders, a digital CBT-guided self-help program, or to referral to usual care.Main outcomes and measuresThe main outcome was change in overall ED psychopathology. Secondary outcomes were abstinence from binge eating and compensatory behaviors, as well as ED behavior frequencies, depression, anxiety, clinical impairment, academic impairment, and realized treatment access.ResultsA total of 690 women with EDs (mean [SD] age, 22.12 [4.85] years; 414 [60.0%] White; 120 [17.4%] Hispanic; 512 [74.2%] undergraduates) were included in the analyses. For ED psychopathology, there was a significantly greater reduction in the intervention group compared with the control group at the postintervention assessment (β [SE], -0.44 [0.10]; d = -0.40; t1387 = -4.23; P < .001), as well as over the follow-up period (β [SE], -0.39 [0.12]; d = -0.35; t1387 = -3.30; P < .001). There was not a significant difference in abstinence from any ED behaviors at the postintervention assessment (odds ratio, 1.48; 95% CI, 0.48-4.62; P = .50) or at follow-up (odds ratio, 1.51; 95% CI, 0.63-3.58; P = .36). Compared with the control group, the intervention group had significantly greater reductions in binge eating (rate ratio, 0.82; 95% CI, 0.70-0.96; P = .02), compensatory behaviors (rate ratio, 0.68; 95% CI, 0.54-0.86; P < .001), depression (β [SE], -1.34 [0.53]; d = -0.22; t1387 = -2.52; P = .01), and clinical impairment (β [SE], -2.33 [0.94]; d = -0.21; t1387 = -2.49; P = .01) at the postintervention assessment, with these gains sustained through follow-up for all outcomes except binge eating. Groups did not differ in terms of academic impairment. The majority of intervention participants (318 of 385 participants [83%]) began the intervention, whereas only 28% of control participants (76 of 271 participants with follow-up data available) sought treatment for their ED (odds ratio, 12.36; 95% CI, 8.73-17.51; P < .001).Conclusions and relevanceIn this cluster randomized clinical trial comparing a coached, digital CBT intervention with referral to usual care, the intervention was effective in reducing ED psychopathology, compensatory behaviors, depression, and clinical impairment through long-term follow-up, as well as realizing treatment access. No difference was found between the intervention and control groups for abstinence for all ED behaviors or academic impairment. Given its scalability, a coached, digital, CBT intervention for college women with EDs has the potential to address the wide treatment gap for these disorders.Trial registrationClinicalTrials.gov Identifier: NCT02076464.
| S-EPMC7489868 | biostudies-literature
Project description:BackgroundDigitalizing the healthcare system has been declared a priority by the UK government. People with eating disorders (EDs), especially those with bulimia nervosa (BN) or binge eating disorder (BED), and ED carers may benefit from online self-help programmes, due to the shame and stigma associated with EDs and barriers in accessing treatment, skills-training or support. Qualitative studies are needed to explore stakeholders' needs, attitudes to and views about online self-help, to optimize intervention design and delivery.MethodsFocus groups and telephone interviews were conducted with people with BN or BED, and carers of people with anorexia nervosa, between March and September 2018 in the UK.ResultsPeople with EDs and carers perceived online self-help positively in the context of barriers to seeking and accessing treatment and support, despite some seeing it as inferior to face-to-face support. Most reported little experience with online interventions. Participants thought the disadvantages of online interventions could be overcome by reminders, progress summaries, regular engagement and engaging with peers. Receiving guidance was seen as an important functionality in the intervention by people with EDs.ConclusionsPeople with EDs and their carers are aware of the potential benefits of online self-help despite having little experience with this form of intervention. A stepped-care approach that utilizes technology-based interventions as a first step and makes such interventions available directly to the consumer may fit the attitudes and needs of stakeholders. The study provides a foundation for future research on design and delivery of ED online self-help.
| S-EPMC8495677 | biostudies-literature