- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06801197
Impact of a Mobile App-Based Waitlist Intervention on Readiness for Eating Disorder Treatment (MI-Coach: ED)
Impact of a Mobile App-Based Waitlist Intervention (MI-Coach: ED) on Readiness for Eating Disorder Treatment: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maya Libben, PhD, R.Psych.
- Phone Number: 250-807-9026
- Email: maya.libben@ubc.ca
Study Contact Backup
- Name: Amané Halicki-Asakawa, M.A.
- Email: amaneha@student.ubc.ca
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada
- Recruiting
- Interior Health, Eating Disorders Program
-
Contact:
- Amane Halicki-Asakawa
- Phone Number: 250 807 9026
- Email: amaneha@student.ubc.ca
-
Surrey, British Columbia, Canada
- Recruiting
- Fraser Health Eating Disorders Program
-
Contact:
- Amane Halicki-Asakawa
- Phone Number: 250 807 9026
- Email: amaneha@student.ubc.ca
-
Vancouver, British Columbia, Canada
- Recruiting
- Vancouver Coastal Health, Eating Disorders Program
-
Contact:
- Amane Halicki-Asakawa
- Phone Number: 250 807 9026
- Email: amaneha@student.ubc.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Treatment Group (MI-Coach: ED Users)
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.
|
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.
|
|
No Intervention: Delayed Treatment Group (Waitlist Control)
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.
|
|
|
Experimental: Combined Treatment Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Overall Motivation for Treatment as Measured by the Readiness and Motivation Questionnaire (RMQ) at 4 Weeks
Time Frame: From enrollment to the end of initial study arm 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
Time Frame: From enrollment to the end of initial study arm at 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
Time Frame: From enrollment to the end of initial study arm 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attrition Rate Between Baseline and 4 Weeks
Time Frame: From enrollment to the end of initial study arm at 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.
|
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)
Time Frame: At 12 weeks
|
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
Time Frame: At 12 weeks
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory Analysis of Changes in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale
Time Frame: Baseline, 4 weeks, and follow-ups at 8 and 12 weeks
|
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.
|
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)
Time Frame: Baseline, 4 weeks, and follow-ups at 8 and 12 weeks
|
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
Time Frame: Baseline, 4 weeks, and follow-ups at 8 and 12 weeks
|
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
Time Frame: Baseline, 4 weeks, and follow-ups at 8 and 12 weeks
|
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
Time Frame: Baseline, 4 weeks, and follow-ups at 8 and 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H24-03392
- 24901 (Other Grant/Funding Number: Social Sciences and Humanities Research Council (SSHRC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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