Clinical trial NCT06801197: Impact of a Mobile App-Based Waitlist Intervention on Readiness for Eating Disorder Treatment
Official title: Impact of a Mobile App-Based Waitlist Intervention (MI-Coach: ED) on Readiness for Eating Disorder Treatment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Eating Disorders
Keywords: eating disorders
digital interventions
motivational interviewing
treatment barriers
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study employs a sequential interventional study design to evaluate the MI-Coach: ED app, ensuring both ethical considerations and robust data collection. Participants are randomized into two groups: the treatment group, which uses the app immediately for four weeks, and the delayed treatment control group, which remains on the waitlist without intervention for four weeks before gaining access to the app. Both groups complete weekly motivation assessments and pre- and post-intervention questionnaires at 0, 4, 8, and 12 weeks. This design allows for between-group comparisons during the initial phase and within-group comparisons after the delayed group transitions to the intervention, capturing immediate, delayed, and sustained effects of the app. By reflecting real-world waitlist scenarios, this model ensures all participants benefit from the intervention while providing valuable longitudinal data to assess its efficacy and practical application.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized controlled trial is to evaluate whether a mobile app-based motivational interviewing intervention (MI-Coach: ED) can improve motivation and readiness for treatment in adults with eating disorders who are currently on waitlists for provincially funded eating disorder services in British Columbia. The main questions it aims to answer are:

* Does the use of MI-Coach: ED improve overall motivation, confidence, and readiness for treatment compared to treatment-as-usual (waitlist with no intervention)?
* Does the app help mitigate declines in motivation over time among waitlisted individuals?

Researchers will compare participants using the MI-Coach: ED app to a delayed treatment control group to assess differences in motivation, readiness for treatment, and associated clinical outcomes.

Participants will:

* Treatment group: Use the MI-Coach: ED app for four weeks, completing interactive modules focused on motivation and readiness for change, while also completing weekly brief assessments of motivation.
* Delayed treatment group: Remain on the waitlist with no intervention for four weeks while completing weekly brief assessments of motivation. After this period, they will receive access to the MI-Coach: ED app and be integrated into the treatment group.
* Complete pre-test and post-test questionnaires at 0, 4, 8, and 12 weeks assessing motivation, eating pathology, anxiety, and depressive symptoms.

This study aims to inform evidence-based practices for reducing the adverse effects of long waitlist durations on individuals with eating disorders.

Detailed description: This study is a randomized controlled trial designed to evaluate the efficacy of MI-Coach: ED, a mobile app-based intervention tailored for adults with eating disorders (EDs) currently on waitlists for provincially funded ED treatment programs in British Columbia, Canada. The study explores how a scalable, self-guided digital tool can support motivation and readiness for treatment during a critical period when access to traditional care is delayed.

MI-Coach: ED leverages evidence-based principles of motivational interviewing (MI) to address ambivalence and enhance intrinsic motivation to engage in treatment. The app features seven interactive modules covering key topics, including self-acceptance, behavior change strategies, and relapse prevention, delivered through videos, exercises, and self-reflection activities. These modules aim to foster readiness for treatment, improve confidence, and maintain motivation during extended wait times.

The trial uses a sequential interventional study design. Participants are randomized into two groups: a treatment group that begins using the MI-Coach: ED app immediately for four weeks and a delayed treatment control group that waits four weeks before accessing the intervention. Both groups complete regular assessments of motivation, readiness for change, eating pathology, anxiety, depressive symptoms, and other clinical characteristics at baseline, 4 weeks, 8 weeks, and 12 weeks. In-app engagement metrics, such as module completion rates, are also collected to evaluate feasibility and acceptability.

This trial incorporates exploratory analyses to investigate the impact of app use on broader clinical outcomes, such as body dissatisfaction and mental health symptoms, and examines whether app engagement predicts clinical improvements. Statistical methods include descriptive analyses, t-tests for between-group comparisons, and linear mixed modeling (LMM) to evaluate longitudinal changes.

The findings aim to inform the integration of digital tools into clinical practice, offering evidence for their utility in mitigating the adverse effects of waitlist delays. By addressing a critical gap in care for individuals with EDs, this study seeks to enhance the accessibility and effectiveness of pre-treatment interventions and contribute to the development of more comprehensive care pathways.

Eligibility criteria: Inclusion Criteria:

* Must self-identify as a woman, including cisgender or transgender individuals.
* Must be at least 18 years old at the time of enrollment.
* Currently on a waitlist to receive treatment for an eating disorder at provincially funded eating disorder programs in British Columbia.
* Meets criteria for a threshold or subthreshold eating disorder, including anorexia nervosa (restricting or binge/purge subtype), bulimia nervosa, binge eating disorder, or other specified feeding or eating disorder (OSFED).
* Able to read and understand English fluently.
* Owns or has regular access to a smartphone or mobile device capable of running the MI-Coach: ED app.

Exclusion Criteria:

* Does not identify as a woman, regardless of sex assigned at birth.
* Currently receiving active treatment for an eating disorder, such as outpatient therapy, inpatient care, or day programs.
* Diagnosed with a schizophrenia-spectrum disorder or other psychotic disorder.
* Presence of a cognitive impairment or sensory deficit (e.g., severe visual or hearing impairment) that would interfere with the ability to use the app or complete study assessments.
* History of a recent traumatic brain injury or neurological condition that might impact participation.
* Any condition that, in the opinion of the investigators, would interfere with the participant's ability to comply with the study protocol or complete the intervention.

Primary outcomes:
measure: Change from Baseline in Overall Motivation for Treatment as Measured by the Readiness and Motivation Questionnaire (RMQ) at 4 Weeks
timeFrame: From enrollment to the end of initial study arm at 4 weeks
measure: Rate of Change in Weekly Motivation Levels as Measured by the Motivational Stages of Change for Adolescents Recovering from an Eating Disorder (MSCARED) During the Initial 4 Weeks
timeFrame: From enrollment to the end of initial study arm at 4 weeks
measure: Change from Baseline in Confidence to Engage in Treatment as Measured by the Confidence Subscale of the Readiness and Motivation Questionnaire (RMQ) at 4 Weeks
timeFrame: From enrollment to the end of initial study arm at 4 weeks
Secondary outcomes:
measure: Attrition Rate Between Baseline and 4 Weeks
timeFrame: From enrollment to the end of initial study arm at 4 weeks
measure: Participant Ratings of App Acceptability as Measured by the User Version of the Mobile App Rating Scale (uMARS)
timeFrame: At 12 weeks
measure: Association Between App Usability and Module Completion Rates
timeFrame: At 12 weeks
Other outcomes:
measure: Exploratory Analysis of Changes in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale
timeFrame: Baseline, 4 weeks, and follow-ups at 8 and 12 weeks
measure: Exploratory Analysis of Changes in Body Dissatisfaction as Measured by the Body Shape Questionnaire (BSQ)
timeFrame: Baseline, 4 weeks, and follow-ups at 8 and 12 weeks
measure: Exploratory Analysis of App Engagement Metrics and Clinical Outcomes
timeFrame: Baseline, 4 weeks, and follow-ups at 8 and 12 weeks
measure: Exploratory Analysis of Changes in Eating Disorder Symptomatology Over Time
timeFrame: Baseline, 4 weeks, and follow-ups at 8 and 12 weeks
measure: Exploratory Analysis of Changes in Depressive Symptoms as Measured by the Patient Health Questionnaire-9 (PHQ-9) Over Time
timeFrame: Baseline, 4 weeks, and follow-ups at 8 and 12 weeks
Locations:
Study officials:
References:
citation: Weiss CV, Mills JS, Westra HA, Carter JC. A preliminary study of motivational interviewing as a prelude to intensive treatment for an eating disorder. J Eat Disord. 2013 Aug 20;1:34. doi: 10.1186/2050-2974-1-34. eCollection 2013.
citation: Linardon J, Shatte A, Messer M, Firth J, Fuller-Tyszkiewicz M. E-mental health interventions for the treatment and prevention of eating disorders: An updated systematic review and meta-analysis. J Consult Clin Psychol. 2020 Nov;88(11):994-1007. doi: 10.1037/ccp0000575. Epub 2020 Aug 27.
citation: Keegan E, Waller G, Tchanturia K, Wade TD. The potential value of brief waitlist interventions in enhancing treatment retention and outcomes: a randomised controlled trial. Cogn Behav Ther. 2024 Nov;53(6):608-620. doi: 10.1080/16506073.2024.2351867. Epub 2024 May 9.
citation: Iyar MM, Cox DW, Kealy D, Srikameswaran S, Geller J. Is stage of change enough? Confidence as a predictor of outcome in inpatient treatment for eating disorders. Int J Eat Disord. 2019 Mar;52(3):283-291. doi: 10.1002/eat.23026. Epub 2019 Jan 30.
citation: Innes NT, Clough BA, Casey LM. Assessing treatment barriers in eating disorders: A systematic review. Eat Disord. 2017 Jan-Feb;25(1):1-21. doi: 10.1080/10640266.2016.1207455. Epub 2016 Aug 2.
citation: Feld R, Woodside DB, Kaplan AS, Olmsted MP, Carter JC. Pretreatment motivational enhancement therapy for eating disorders: a pilot study. Int J Eat Disord. 2001 May;29(4):393-400. doi: 10.1002/eat.1035.
citation: Casasnovas C, Fernandez-Aranda F, Granero R, Krug I, Jimenez-Murcia S, Bulik CM, Vallejo-Ruiloba J. Motivation to change in eating disorders: clinical and therapeutic implications. Eur Eat Disord Rev. 2007 Nov;15(6):449-56. doi: 10.1002/erv.780.
citation: Carter O, Pannekoek L, Fursland A, Allen KL, Lampard AM, Byrne SM. Increased wait-list time predicts dropout from outpatient enhanced cognitive behaviour therapy (CBT-E) for eating disorders. Behav Res Ther. 2012 Aug;50(7-8):487-92. doi: 10.1016/j.brat.2012.03.003. Epub 2012 Mar 30.
citation: Austin A, Flynn M, Richards K, Hodsoll J, Duarte TA, Robinson P, Kelly J, Schmidt U. Duration of untreated eating disorder and relationship to outcomes: A systematic review of the literature. Eur Eat Disord Rev. 2021 May;29(3):329-345. doi: 10.1002/erv.2745. Epub 2020 Jun 23.