Impact of a Mobile App-Based Waitlist Intervention on Readiness for Eating Disorder Treatment

Официальное название

Impact of a Mobile App-Based Waitlist Intervention (MI-Coach: ED) on Readiness for Eating Disorder Treatment: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт MI-Coach: ED Mobile App
  The MI-Coach: ED mobile app is a self-guided intervention designed to enhance motivation and readiness for treatment in adults with eating disorders. The app includes seven sequential modules based on motivational interviewing (MI) principles, addressing ambivalence, self-acceptance, compassionate motivation, behavior change goals, sustain and change talk, commitment language, and relapse prevention. Each module incorporates interactive content, including educational videos, articles, and exerci

Первичные конечные точки

• Change from Baseline in Overall Motivation for Treatment as Measured by the Readiness and Motivation Questionnaire (RMQ) at 4 Weeks [Срок оценки: From enrollment to the end of initial study arm at 4 weeks]
• 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 [Срок оценки: From enrollment to the end of initial study arm at 4 weeks]
• 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 [Срок оценки: From enrollment to the end of initial study arm at 4 weeks]

Вторичные конечные точки (3)

• Attrition Rate Between Baseline and 4 Weeks [Срок оценки: From enrollment to the end of initial study arm at 4 weeks]
• Participant Ratings of App Acceptability as Measured by the User Version of the Mobile App Rating Scale (uMARS) [Срок оценки: At 12 weeks]
• Association Between App Usability and Module Completion Rates [Срок оценки: At 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 3 центра

• Interior Health, Eating Disorders Program — Kelowna
• Fraser Health Eating Disorders Program — Surrey
• Vancouver Coastal Health, Eating Disorders Program — Vancouver

Публикации

• 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. PMID 24999413
• 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. PMID 32852971
• 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. PMID 38721888
• 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. PMID 30701590
• 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. PMID 27485375
• 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. PMID 11285576
• 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. PMID 17960774
• 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. PMID 22659158

Идентификаторы

NCT: NCT06801197 · H24-03392 · 24901

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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