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

NCT06801197 | Recruiting

• 2 other identifiers: H24-0339224901
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

Eating Disorders

Keywords

eating disorders; digital interventions; motivational interviewing; treatment barriers

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Overall Motivation for Treatment as Measured by the Readiness and Motivation Questionnaire (RMQ) at 4 Weeks

  Overall motivation for treatment will be assessed using the Readiness and Motivation Questionnaire (RMQ), a validated measure evaluating readiness to change eating disorder symptoms and behaviors. The RMQ provides a total motivation score (ranging from 0 to 100) and includes subscales for precontemplation, action, internality, and confidence. Higher scores indicate greater readiness for treatment. Changes from baseline to 4 weeks will be evaluated using linear mixed modeling (LMM), accounting for fixed effects (treatment group, time) and random effects (individual variability). A significant change from baseline will be defined as a statistically significant fixed effect of time (p \< 0.05), with a greater increase in motivation scores observed in the treatment group compared to the delayed treatment control group.

  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

  Weekly motivation will be assessed using the Motivational Stages of Change for Adolescents Recovering from an Eating Disorder (MSCARED), a single-item self-report measure. Participants select their current stage of change from six stages: precontemplation, contemplation, preparation, action, maintenance, and recovery. Rate of change will be calculated using LMM, incorporating interaction terms between treatment group and time to evaluate differences in the trajectory of weekly motivation. A significant result will be defined as a statistically significant interaction term (p \< 0.05), indicating a slower decline or greater increase in motivation over time in the treatment group compared to the delayed treatment control group.

  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

  Confidence to engage in treatment will be assessed using the confidence subscale of the RMQ, which measures participants' belief in their ability to address eating disorder behaviors. Scores range from 0 to 100, with higher scores indicating greater confidence. Changes from baseline to 4 weeks will be analyzed using LMM, incorporating fixed effects for treatment group and time, and random effects for individual differences. A significant change from baseline will be defined as a statistically significant fixed effect of time (p \< 0.05), with confidence scores in the treatment group showing stability or improvement compared to the delayed treatment control group.

  From enrollment to the end of initial study arm at 4 weeks

Secondary Outcomes (3)

• Attrition Rate Between Baseline and 4 Weeks

  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)

  At 12 weeks

• Association Between App Usability and Module Completion Rates

  At 12 weeks

Other Outcomes (5)

• Exploratory Analysis of Changes in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale

  Baseline, 4 weeks, and follow-ups at 8 and 12 weeks

• Exploratory Analysis of Changes in Body Dissatisfaction as Measured by the Body Shape Questionnaire (BSQ)

  Baseline, 4 weeks, and follow-ups at 8 and 12 weeks

• Exploratory Analysis of App Engagement Metrics and Clinical Outcomes

  Baseline, 4 weeks, and follow-ups at 8 and 12 weeks

Study Arms (3)

Immediate Treatment Group (MI-Coach: ED Users)

EXPERIMENTAL

Participants randomized to the immediate treatment group will begin using the MI-Coach: ED app immediately for a four-week intervention period. During this time, participants will complete interactive modules designed to enhance motivation and readiness for treatment, focusing on topics such as ambivalence, self-acceptance, compassionate motivation, and behavior change strategies. Weekly brief assessments of motivation and readiness for change will be completed throughout the initial four-week period.

Combination Product: MI-Coach: ED Mobile App

Delayed Treatment Group (Waitlist Control)

NO INTERVENTION

Participants randomized to the delayed treatment group will remain on the waitlist without access to the MI-Coach: ED app for the first four weeks. During this period, participants will complete weekly brief assessments of motivation and readiness for change to evaluate changes while waiting for access to the intervention. No additional interventions or activities will be provided during this initial four-week period.

Combined Treatment Group

EXPERIMENTAL

This arm includes all participants who engage with the MI-Coach: ED app during the eight weeks following the initial four-week period. Participants from the immediate treatment group (Arm 1) will continue to use the app for the full 12 weeks of the study, including an eight-week extended intervention period and follow-up assessments at 8 and 12 weeks to evaluate the app's sustained effects. Participants transitioning from the delayed treatment group (Arm 2) will also use the app for an eight-week intervention period after their initial four-week waitlist phase, ensuring both groups have the same opportunity to complete the full intervention. Weekly assessments of motivation and readiness for change will continue for all participants during their respective intervention periods, along with follow-up assessments to compare immediate and delayed access effects, as well as the app's long-term impact on motivation and clinical outcomes.

Combination Product: MI-Coach: ED Mobile App

Interventions

MI-Coach: ED Mobile App COMBINATION_PRODUCT

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 exercises, tailored to support motivation across a range of eating disorder diagnoses. The app is designed to be user-friendly and scalable, providing an accessible, cost-effective solution for individuals on waitlists for formal eating disorder treatment.

Combined Treatment Group; Immediate Treatment Group (MI-Coach: ED Users)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is open to individuals who self-identify as women, including cisgender women and transgender individuals who identify as women. The inclusion criteria are based on self-reported gender identity, ensuring the study captures the experiences of a diverse group of women. Individuals who do not identify as women, regardless of sex assigned at birth, are not eligible to participate in this trial. This criterion is intended to align with the study's focus on evaluating the MI-Coach: ED app within this specific population.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (3)

Interior Health, Eating Disorders Program

Kelowna, British Columbia, Canada

RECRUITING

Fraser Health Eating Disorders Program

Surrey, British Columbia, Canada

RECRUITING

Vancouver Coastal Health, Eating Disorders Program

Vancouver, British Columbia, Canada

RECRUITING

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 32578311 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Maya Libben, PhD, R.Psych.

CONTACT

250-807-9026; maya.libben@ubc.ca

Amané Halicki-Asakawa, M.A.

CONTACT

amaneha@student.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 30, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

CA (3)