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| ID | Type | Description | Link |
|---|---|---|---|
| 24901 | Other Grant/Funding Number | Social Sciences and Humanities Research Council (SSHRC) |
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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:
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:
This study aims to inform evidence-based practices for reducing the adverse effects of long waitlist durations on individuals with eating disorders.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Attrition Rate Between Baseline and 4 Weeks | Attrition will be measured as the percentage of participants who do not complete study activities (e.g., assessments or app usage) within the first 4 weeks. Descriptive statistics, including means, percentages, and ranges, will be calculated to summarize attrition rates for both groups. Simple t-tests will be used to compare mean attrition rates between the treatment and delayed treatment control groups, with a significant difference defined as a p-value < 0.05, indicating lower attrition in the treatment group. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Analysis of Changes in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale | Anxiety symptoms will be assessed using the GAD-7, a validated self-report measure with scores ranging from 0 to 21 (higher scores indicate greater severity of anxiety symptoms). Descriptive statistics, including means and standard deviations, will summarize anxiety scores at baseline, 4 weeks, and follow-up time points. Exploratory analyses will use simple t-tests to compare changes in mean anxiety scores between the treatment and delayed treatment control groups at 4 weeks. Changes over time will also be analyzed using linear mixed modeling (LMM) to evaluate group differences in trajectories. Statistical significance will be defined as p < 0.05 for group comparisons or time effects. |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Libben, PhD, R.Psych. | Contact | 250-807-9026 | maya.libben@ubc.ca | |
| Amané Halicki-Asakawa, M.A. | Contact | amaneha@student.ubc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Interior Health, Eating Disorders Program | Recruiting | Kelowna | British Columbia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24999413 | Background | 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. | |
| 32852971 | 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. |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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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.
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| From enrollment to the end of initial study arm at 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) | Acceptability of the MI-Coach: ED app will be assessed using the User Version of the Mobile App Rating Scale (uMARS). This scale includes subscales for engagement, functionality, aesthetics, and information quality, each rated on a 5-point Likert scale (1 = inadequate, 5 = excellent). Descriptive statistics (means, standard deviations, ranges) will summarize acceptability scores for each subscale and overall scores. Scores averaging ≥ 4 will indicate a "high" or "very high" level of acceptability for the app. | At 12 weeks |
| Association Between App Usability and Module Completion Rates | App usability will be assessed using the ease of use and perceived usefulness subscales of the uMARS. Engagement metrics, including the number of modules completed, days the app was used, assessments and exercises completed, and logins, will be obtained from in-app data provided by Resiliens Inc. Generalized linear regression models will evaluate the relationship between usability scores and app engagement metrics, with significant associations defined as a p-value < 0.05. Descriptive statistics will summarize app engagement metrics. | At 12 weeks |
| 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) | Body dissatisfaction will be assessed using the BSQ, a 34-item self-report measure with scores ranging from 34 to 204 (higher scores indicate greater dissatisfaction with body shape). Descriptive statistics will summarize scores at baseline, 4 weeks, and follow-up time points. Simple t-tests will compare mean changes in body dissatisfaction scores between the treatment and delayed treatment control groups at 4 weeks. LMM will explore whether group differences emerge in body dissatisfaction trajectories across time points, with statistical significance defined as p < 0.05. | Baseline, 4 weeks, and follow-ups at 8 and 12 weeks |
| Exploratory Analysis of App Engagement Metrics and Clinical Outcomes | App engagement metrics, including the number of modules completed, days the app was used, assessments and exercises completed, and logins, will be extracted from in-app data provided by Resiliens Inc. Exploratory analyses will examine associations between engagement metrics and changes in clinical outcomes (e.g., motivation, anxiety, body dissatisfaction). Generalized linear regression models will evaluate the predictive relationship between engagement metrics (independent variables) and changes in outcome measures (dependent variables). Descriptive statistics will summarize engagement patterns, and statistical significance will be defined as p < 0.05 for predictive associations. | Baseline, 4 weeks, and follow-ups at 8 and 12 weeks |
| Exploratory Analysis of Changes in Eating Disorder Symptomatology Over Time | Eating disorder symptomatology will be assessed using the RMQ symptom-specific subscales (e.g., cognitive, bingeing, compensatory strategies, restriction), with scores ranging from 0 to 100. Exploratory analyses will examine changes in symptom-specific subscale scores between the treatment and delayed treatment control groups using t-tests for between-group differences at 4 weeks and LMM to evaluate changes over time. Descriptive statistics will summarize baseline and follow-up scores, with statistical significance defined as p < 0.05 for group differences or time effects. | Baseline, 4 weeks, and follow-ups at 8 and 12 weeks |
| Exploratory Analysis of Changes in Depressive Symptoms as Measured by the Patient Health Questionnaire-9 (PHQ-9) Over Time | Depressive symptoms will be assessed using the PHQ-9, with scores ranging from 0 to 27 (higher scores indicate greater depressive severity). Exploratory analyses will compare changes in PHQ-9 scores between the treatment and delayed treatment control groups at 4 weeks using t-tests. LMM will analyze trajectories over time to explore whether differences emerge between groups. Descriptive statistics will summarize scores at baseline and follow-ups, with significance defined as p < 0.05. | Baseline, 4 weeks, and follow-ups at 8 and 12 weeks |
| Fraser Health Eating Disorders Program | Recruiting | Surrey | British Columbia | Canada |
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| Vancouver Coastal Health, Eating Disorders Program | Recruiting | Vancouver | British Columbia | Canada |
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| 38721888 | 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. |
| 30701590 | 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. |
| 27485375 | 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. |
| 11285576 | 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. |
| 17960774 | 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. |
| 22659158 | 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. |
| 32578311 | 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. |