Impact of a Mobile App-Based Waitlist Intervention (MI-Coach: ED) on Readiness for Eating Disorder Treatment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: MI-Coach: ED Mobile App (Combination Product)
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.
干预措施: MI-Coach: ED Mobile App (Combination Product)
结局指标
主要结局
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
时间窗: 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.
Change from Baseline in Overall Motivation for Treatment as Measured by the Readiness and Motivation Questionnaire (RMQ) at 4 Weeks
时间窗: 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.
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
时间窗: 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.
次要结局
- Participant Ratings of App Acceptability as Measured by the User Version of the Mobile App Rating Scale (uMARS)(At 12 weeks)
- Attrition Rate Between Baseline and 4 Weeks(From enrollment to the end of initial study arm at 4 weeks)
- Association Between App Usability and Module Completion Rates(At 12 weeks)
研究者
Maya Libben
Associate Professor of Psychology
University of British Columbia