Efficacy of Juniver, a Digital Self-help Intervention, on Symptoms of Eating Disorders: A Randomised Controlled Trial

NCT06226233 | Active Not Recruiting

• 3 other identifiers: JUNIVER-ED001HR/DP-23/24-3971410060885
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to assess the efficacy of the Juniver program on symptoms of eating disorders via a randomised controlled trial. The Juniver program is a self-help intervention for eating disorders delivered digitally, through an iPhone app. It features three components: an evidence-based curriculum, interactive tools, and moderated peer support groups. These three components integrate the evidence for (a) Cognitive-Behavioural Therapy (CBT) and Dialectical Behaviour Therapy for eating disorders; (b) Just-in-Time Adaptive Intervention; and (c) peer mentorship as an adjunct intervention for the treatment of eating disorders. The program was developed by the Juniver team made up of people with lived experience with eating disorders and professional experience in digital health, a panel of neuroscientists and experts specialising in eating disorders, and direct research with 500 participants. This trial aims to investigate the impact of the Juniver program on self-reported eating disorder symptoms, as well as on symptoms of depression, anxiety, psychosocial impairment associated with eating disorders, and perceived stress. This will occur via a randomised controlled trial comparing Juniver to a wait-list control condition over a 12-week period, with further evaluation of the effects of Juniver up to 24-weeks.

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Binge Eating; Eating Disorders; Disordered Eating

Keywords

Eating disorders; Anorexia nervosa; Bulimia nervosa; Binge eating disorder; Just in time interventions; Digital interventions; Mental health

Outcome Measures

Primary Outcomes (1)

• Eating Disorder Examination-Questionnaire (EDE-Q) Eating Disorder Examination-Questionnaire (EDE-Q)

  Self-report measure of eating disorder symptoms

  12 weeks

Secondary Outcomes (4)

• Patient Health Questionnaire-9 (PHQ-9)

  12 weeks

• Generalised Anxiety Disorder-7 questionnaire (GAD-7)

  12 weeks

• Clinical Impairment Questionnaire (CIA 3.0)

  12 weeks

• Perceived Stress Scale (PSS-4)

  12 weeks

Other Outcomes (1)

• Acceptability of the Juniver program

  24 weeks

Study Arms (2)

Juniver intervention group

EXPERIMENTAL

Immediate access to the Juniver program

Other: Juniver program

Wait list control

NO INTERVENTION

Access to the Juniver program after 12 weeks

Interventions

Juniver program OTHER

The Juniver program is a self-help intervention for eating disorders delivered digitally, through an iPhone app. It features three components: an evidence-based curriculum, interactive tools, and moderated peer support groups.

Juniver intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 16 or over
• Live in the UK or the US
• Any presence and severity of any eating disorder(s): Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding and Eating Disorders (OSFED), Avoidant Restrictive Food Intake Disorder (ARFID) and Unspecified Feeding or Eating Disorder (UFED) as measured by the EDE-Q and using item-based algorithms to determine the potential presence of one of these eating disorders
• Able to provide informed consent
• Willing to provide full contact details including a UK or US address, phone number and email address
• Willing to provide contact details for a health care professional with whom they are registered (e.g., a general practitioner or primary care physician) and who the study team can contact if they are concerned about their well-being.

You may not qualify if:

• Lack of access to an iPhone - as Juniver is currently only available for use on the iPhone system.
• Partaking in any medically-driven special diets (e.g., linked to Coeliac, Crohn's, PCOS, type 1 or type 2 diabetes) - as these individuals would require more specialist dietary advice than the Juniver program can safely provide. Individuals with these conditions who are not on special diets would be eligible to enrol.
• Severe depression as measured by PHQ score \> 20
• Active suicidal intent or plan
• Body Mass Index (BMI) \<15
• Emergency hospital visit or admission within the last month for an eating disorder or other mental health concern

Sponsors & Collaborators

• King's College London: lead
• Juniver: collaborator
• Innovate UK: collaborator

Study Sites (1)

King's College London

London, London, SE5 8AZ, United Kingdom

Location

Related Links

• Trial website

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Bulimia; Psychological Well-Being

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperphagia; Personal Satisfaction; Behavior

Study Officials

• Karina Allen, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The Juniver program is a self-help intervention for eating disorders delivered digitally, through an iPhone app. It features three components: an evidence-based curriculum, interactive tools, and moderated peer support groups. This trial aims to investigate the impact of the Juniver program on self-reported eating disorder symptoms, as well as on symptoms of depression, anxiety, psychosocial impairment associated with eating disorders, and perceived stress. This will occur via a randomised controlled trial comparing Juniver to a wait-list control condition over a 12-week period, with further evaluation of the effects of Juniver up to 24-weeks.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: December 23, 2023
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)