Efficacy of Juniver on eating disorders symptoms
Research type
Research Study
Full title
Efficacy of Juniver, a digital self-help intervention, on symptoms of eating disorders: A randomised controlled trial
IRAS ID
329925
Contact name
Karina Allen
Contact email
Sponsor organisation
Juniver
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The Juniver application was conceived by integrating the evidence supporting the effectiveness of mHealth applications that concentrate on micro-interventions tailored to an individual's daily life, considering their specific level of motivation at any given moment. The objective was to address the unmet needs during the experience of an urge by providing resources to comprehend the neural processes underlying their disorder and empowering them to self-manage their recovery. This project employs a randomised, waitlist-controlled, pivotal controlled trial to investigate the impact of the Juniver application on self-reported eating disorder symptoms, as well depression, anxiety, psychosocial impairment associated with eating disorders and perceived stress. The study will include a sample size of 300 participants, with 150 participants randomly allocated at a 1:1 ratio. Participants assigned to the Juniver group will gain access to the app starting on their respective Week 1. In contrast, participants in the control group will receive access to the app at the conclusion of their respective Week 12. The Juniver group will complete outcome measures at Week 4, 8, 12, 16, 20 and 24 while the control group will complete measures at Week 4, 8 and 12. Semi-structured virtual interviews with the Co-Investigator or Research Assistant will be conducted with a sub-set of participants from the Juniver group who provide additional consent for interview participation. These interviews will delve into the participants' personal experiences and perspectives, allowing us to gain insights and inform refinement of our intervention and will be incentivised with a £25 voucher. Statistical analysis will involve linear mixed models to compare differences in outcome measures in the Juniver group compared to the control group, including any overall between-group differences and any differences in how variables change over time.
REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0680
Date of REC Opinion
21 Aug 2023
REC opinion
Unfavourable Opinion