None listed
Conditions
Brief summary
The present research is evaluating the efficacy of an app-based prevention and early intervention program (SEED) targeting eating disorder symptoms in adults. Developed by the WIRED project, the SEED app is a 10-week eHealth intervention which integrates cognitive behavioural techniques, psychoeducation, media literacy, and acceptance and mindfulness relaxation with the aim to modify participants’ attitudes and behaviours relative to their body image and eating/exercise habits. The randomized controlled trial will compare three conditions: (1) waitlist control group, (2) self-guided use of our intervention app (WIRED), and (3) tailored use of our intervention app (i.e., matching content based on participant’s symptom profile at baseline and also during the intervention phase). We hypothesize that, compared to a waitlist control condition, the two WIRED intervention groups will demonstrate improvements in eating disorder symptoms and related secondary outcomes and indicate cost-effectiveness of the intervention, with pronounced improvements in the tailored WIRED group relative to the self-guided WIRED group.
Interventions
Web- and app-based Interventions for Reducing Eating Disorders (WIRED) project are developing a 10-week individual intervention, delivered via our smartphone app. The 10-week app-based intervention (titled SEED) includes text, audio, and visual content adapted from the research team’s prior trials: (i) cognitive behavioural techniques (including dissonance techniques) to challenge disordered eating thought patterns and encourage healthy lifestyle choices to supplant eating disorder (ED) behaviours; (ii) psycho-education about healthy eating and exercise habits and dangers of EDs; (iii) media literacy development to reduce social media influence on ED symptoms; and (iv) acceptance and mindfulness relaxation to disrupt the influence of negative mood on binge eating. In total, there will be 8 modules of content, each expected to take about 1-2 hours per week to complete. Our study is an RCT with three arms: waitlist control, WIRED-matched, and WIRED self-guided. Our study involves three phases: Phase 1 involves self-report measures via a web-based survey (hosted by Qualtrics) and a phone interview to confirm level of eating disorder symptoms. The phone interview will be conducted by a research assistant who has been trained by clinical staff within the team to use the screening interview tool. The initial interview will last approximately 15-30 minutes. Phase 2 is the 10-week intervention with three arms: (1) waitlist control, (2) self-guided use of the app intervention, and (3) matched / guided app use based on symptom profile at baseline. Adherence to the app will be monitored automatically through the app. If participants have not used the app within a specific time period (e.g., 1-week), the app will send a notification to the participant to prompt them to use the app. Phase 3 involves completing the baseline survey again immediately post-intervention, and at 6- and 12-months post-intervention to observe maintenance and continued improvement in symptom reduction. At each of these timepoints, participants will also receive a phone call check-in with a research assistant on the project to see how they are going, and to remind them to complete the current survey. At the immediate post-intervention point, this phone call will also involve reassessment of ED symptom levels. The immediate post-intervention phone interview will be shorter than the baseline interview, taking approximately 10-15 minutes. The check-in phone calls at 6- and 12-month follow-up will likely be very brief as they’re primarily used to remind the participant to complete the online survey. The intervention content is the same for both the WIRED-matched and WIRED-self-guided arms, though the order and prioritisation of content will be different as WIRED-matched tailors the content delivery to most pressing needs based on symptoms at baseline.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults aged 18 and over who may have a subclinical or full eating disorder diagnosis for the main ED subtypes, specifically bulimia nervosa (BN), binge eating disorder (BED), body dysmorphia disorder (BDD; specific to dysmorphia with the body rather than face), other specified feeding or eating disorder (OSFED), and unspecified feeding or eating disorder (UFED). Diagnosis information will be self-reported in the baseline survey and a clinical phone interview will also be completed to determine eligibility. In addition, the baseline online survey includes several screening questions to identify those who will probably meet the clinical/subclinical threshold for inclusion into the study. These items ask whether participants have dieted during the past 6 months, and whether they have been concerned about their body, body image, or physical appearance during the past 6 months. These two items are based on prior eHealth interventions for body image and ED, and provide a good screener to reduce the number of phone interviews required overall. Finally, access to a smartphone throughout duration of 10-week intervention phase of research participation is a necessary inclusion criterion for the study.
Exclusion criteria
Participants with a diagnosis of (or symptoms consistent with) Anorexia Nervosa (AN; including Atypical AN), Avoidant/restrictive food intake disorder (ARFID), Pica, Rumination Disorder, and BDD (specific to dysmorphia related to facial rather than bodily appearance) will not be eligible to participate. These individuals will instead be provided with referral information for treatment and support. Our baseline survey includes a question about suicidality (‘Over the last 2 weeks, how often have you had thoughts that you would be better off dead or hurting yourself in some way?’). Participants who answer above zero (“not at all”) will be excluded from the study, and instead recommended free counselling options such as lifeline, as well as being made aware of GP referral to psychologists.