Acquisition and Utilization of Skills Using Innovative Smartphone Application for Regular Eating

Study Overview
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Brief Summary
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The study seeks to evaluate the acceptability, feasibility, target engagement, and validity of an innovative smartphone application with ecological momentary interventions to augment cognitive behavioral therapy for bulimia nervosa.

Official Title
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Using Ecological Momentary Interventions to Increase Skill Acquisition and Utilization

Conditions
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Bulimia, Bulimia Nervosa, Binge Eating, Purging, Eating Disorder

Intervention / Treatment
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* Behavioral: CBT+ application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets criteria for bulimia nervosa or sub-threshold bulimia nervosa with subjective binge episodes (objective binge episodes or subjective binge episodes AND compensatory behaviors at least 1 time per week on average for the past 3 months) BMI >17.5 Have a smartphone device Willing and able to use smartphone device to track food intake multiple times per day for 16 weeks Exclusion Criteria: Pregnant or planning to become pregnant in the next year Currently experiencing severe psychopathology that would limit their ability to engage in study (e.g. suicidality, substance use disorder, psychotic disorder) Have previously received a full trial of CBT for bulimia nervosa History of bariatric surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT with smartphone application (EMI on)<br>CBT with CBT+ smartphone application (EMI on) | Behavioral: CBT+ application<br>* Smartphone application that comprises electronic self-monitoring of food intake, eating disorder behaviors, and mood and ecological momentary interventions<br>* Other names: CBT+;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge and purge frequency assessed by the Eating Disorder Examination | Frequency (number of days and number of instances) of binge eating and compensatory behaviors over the past 28 days assessed by the Eating Disorder Examination | Change from baseline assessment (before beginning treatment) to post-treatment assessment (16 weeks after baseline assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Disorder Examination Questionnaire (EDE-Q) | The Eating Disorder Examination Questionnaire measures eating pathology. The EDE-Q yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE-Q will be used to assess utilization of skills related to reducing dietary restraint. | Assessed at weekly treatment sessions throughout treatment duration (16 weeks) | 
| Difficulties in Emotion Regulation Scale (DERS) | The Difficulties in Emotion Regulation Scale is a self-report measure of emotional dysregulation. The DERS yields 6 subscale scores (Awareness, Clarity, Goals, Impulse, Nonacceptance, and Strategies) and a total score. The possible score range for each subscale is 3 to 15. The total score is computed by summing all 6 subscales, so the possible score range is 18 to 90. For all subscales and the total score, higher scores indicate greater difficulty in emotion regulation. The DERS will be used to assess utilization of skills related to increasing adaptive responses to cues. | Assessed at weekly treatment sessions throughout treatment duration (16 weeks) | 
| Technology Acceptance Model Scale (TAMS) | The Technology Acceptance Model Scale measures usefulness and ease of use of a technological product. The TAMS yields two subscale scores (usefulness and ease of use). The possible score range for each subscale is 6 to 49. Higher scores indicate greater usefulness and ease of use. The TAMS will be used to assess the perceived usefulness and perceived ease-of-use of the smartphone application to evaluate acceptability. | Assessed at weekly treatment sessions throughout treatment duration (16 weeks) | 
| Feedback Questionnaire (FQ) | The feedback questionnaire asks qualitative questions about the application. The feedback questionnaire does not report either subscale scores or a total score. The FQ will be used to obtain qualitative acceptability ratings. | Assessed at weekly treatment sessions throughout treatment duration (16 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bulimia, Bulimia Nervosa, Eating Disorder, Binge Eating, Purging