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Clinical Trials/NCT03673540
NCT03673540CompletedNot Applicable

Using Ecological Momentary Interventions to Increase Skill Acquisition and Utilization

Drexel University1 site in 1 country61 target enrollmentStarted: August 31, 2018Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61
Locations
1
Primary Endpoint
Binge and purge frequency assessed by the Eating Disorder Examination
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

CBT with smartphone application (EMI on)

Experimental

CBT with CBT+ smartphone application (EMI on)

Intervention: CBT+ application (Behavioral)

Outcomes

Primary Outcomes

Binge and purge frequency assessed by the Eating Disorder Examination

Time Frame: 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 Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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