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

Not Applicable

Completed

• Conditions: Eating Disorder; Bulimia; Binge Eating; Purging; Bulimia Nervosa
• Interventions: Behavioral: CBT+ application

• Registration Number: NCT03673540
• Lead Sponsor: Drexel University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-31
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBT with smartphone application (EMI on)	CBT+ application	CBT with CBT+ smartphone application (EMI on)

Primary Outcome Measures

Name	Time	Method
Binge and purge frequency assessed by the Eating Disorder Examination	Change from baseline assessment (before beginning treatment) to post-treatment assessment (16 weeks after baseline assessment)	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

Secondary Outcome Measures

Name	Time	Method
Eating Disorder Examination Questionnaire (EDE-Q)	Assessed at weekly treatment sessions throughout treatment duration (16 weeks)	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.
Difficulties in Emotion Regulation Scale (DERS)	Assessed at weekly treatment sessions throughout treatment duration (16 weeks)	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.
Technology Acceptance Model Scale (TAMS)	Assessed at weekly treatment sessions throughout treatment duration (16 weeks)	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.
Feedback Questionnaire (FQ)	Assessed at weekly treatment sessions throughout treatment duration (16 weeks)	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.

Trial Locations

Locations (1)

Drexel University, Stratton Hall; 🇺🇸 Philadelphia, Pennsylvania, United States