None listed
Conditions
Brief summary
Only 25% of individuals with an eating disorder receive treatment, and this includes gay men, who are one of the most vulnerable populations for experiencing these debilitating disorders. Our eHealth intervention, SEED, was co-designed with clinicians, researchers, and gay men to treat eating disorder symptoms, and is intended to be a freely available resource that fills the gap between non-evidence-based but freely available psychoeducation on the Internet (e.g., self-help articles) and evidence-based but expensive psychotherapy (e.g., a $220 session with a clinical psychologist). Our study examined whether SEED is effective in reducing eating disorder symptoms, and whether providing personalised recommendations as part of the app improves how effective it is.
Interventions
SEED is a 10-week app-based intervention that includes text, audio, and visual content incorporating (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 are 8 modules of content, each taking about 1-2 hours per week to complete. Overview of app modules: 1. Values and Motivations: Introduction to values, identifying values, and building motivation to change in accordance with values. 2. Regulated Eating: Psychoeducation on regular eating, compensatory behaviours, strategies to help with regular eating. 3. Mood Management: Identifying, challenging, and balancing negative thoughts 4. Diet Rules and Exercise: Identifying beliefs about dieting, challenging unhelpful beliefs, and generating positive attitudes about exercise 5. Overvaluation: Psychoeducation on overvaluation of appearance, societal influences on appearance values, and challenging these societal messages about appearance and diet 6. Body Checking & Appearance Comparisons: Body checking, appearance comparisons, the role of social media in facilitating body checking & appearance comparisons. 7. Emotion Regulation: Linking emotions to eating and appearance, learning emotion regulation techniques, distress tolerance. 8. Maintaining Progress: Identifying and managing relapses, generating a relapse plan. This study comprised three phases. PHASE 1: In Phase 1, participants completed a (i) screening survey to assess their eligibility for an interview, (ii) a phone interview to confirm eating disorder diagnosis symptoms/diagnosis (including prodromal cases), and (iii) a baseline self-report survey to examine key study outcomes. The screening survey allowed us to screen potential participants as eligible or ineligible to participate. Participants were eligible if they had engaged in dieting and expressed concern about their physical appearance in the past 6 months, and were not at risk of suicide. Eligible participants were invited to complete a the Eating Disorder Interview (administered by a provisional or registered psychologist) over the phone or via video conference call (e.g., Zoom), lasting approximately 30-45 minutes. Participants confirmed as having a prodromal or clinical eating disorder were enrolled in the trial whilst participants without an eating disorder, or with an ineligible eating disorder diagnosis, were given access to the intervention content but were not enrolled in the trial. At the end of the clinical interview, participants were randomised to one of three arms using Qualtrics in-built randomisation function: 1. Personalised intervention arm: in this condition, participants were able to complete the 10-week program flexibly (i.e., in any order), and were provided personalised content recommendations based on their self-reported eating disorder symptoms (e.g., those who had high scores on binge eating were recommended to first complete the 'Regulated Eating' and 'Mood Management' modules, before moving onto other modules). These personalised content recommendations were emailed to participants by the research team following their clinical interview, and participants were instructed to not start using the app before receiving these recommendations. 2. Default intervention arm: in this condition, participants completed SEED in a sequential order (Modules 1 to 8), and were not provided personalised content recommendations. 3. Waitlist Control: in this condition, participants were given access to the default version of the app at the 10-week follow up. Eligible participants completed a survey containing baseline measures after the EDE interview. The baseline survey includes measures of key study outcomes, including over-valuation, exercise, appearance comparisons, social media literacy, and quality of life. PHASE 2: Eligible participants from Phase 1 completed the 10-week intervention (except for waitlist control participants, who are given access to the app at the start of Phase 3). The intervention - named SEED - was developed for this study, incorporating evidence-based strategies for treating eating disorders (e.g., Cognitive Behavioural Therapy). While using the app, participants were asked to provide text responses to questions and activities, such as stating their values and goals. While the SEED app was set up to record adherence to the intervention (e.g., app login data, number of content modules completed), a technical error meant that this data could not be accessed. PHASE 3: All participants completed the baseline survey and phone interview immediately post-intervention, and waitlist control participants were granted access to the app at this stage. All participants re-completed the baseline survey at 6- and 12-months post-intervention.
Sponsors
Study design
Eligibility
Inclusion criteria
The eligibility criteria for our trial were: (1) cis-gender men who are not exclusively heterosexual, (2) 18 years or older, (3) not at risk of suicide, (4) met criteria for a sub-clinical or clinical eating disorder diagnosis (exclusions: Atypical Anorexia Nervosa, Anorexia Nervosa, and Avoidant Restrictive Food Intake Disorder), and (5) not currently receiving treatment for eating or body image concerns.
Exclusion criteria
Exclusion criteria are subsumed in the inclusion criteria - i.e., does not meet criteria for clinical or sub-clinical eating disorder diagnosis; diagnosis of Atypical Anorexia Nervosa, Anorexia Nervosa, and Avoidant Restrictive Food Intake Disorder; currently receiving treatment for eating or body image concerns.