Clinical trial NCT03673540: Acquisition and Utilization of Skills Using Innovative Smartphone Application for Regular Eating
Official title: Using Ecological Momentary Interventions to Increase Skill Acquisition and Utilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Bulimia
Binge Eating
Purging
Eating Disorder
Keywords: Bulimia Nervosa
Eating Disorder
Binge Eating
Bulimia
Purging
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-09-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Binge and purge frequency assessed by the Eating Disorder Examination
timeFrame: Change from baseline assessment (before beginning treatment) to post-treatment assessment (16 weeks after baseline assessment)
Secondary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
measure: Technology Acceptance Model Scale (TAMS)
timeFrame: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
measure: Feedback Questionnaire (FQ)
timeFrame: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University, Stratton Hall
state: Pennsylvania
Study officials:
References:
citation: Presseller EK, Wilkinson ML, Trainor C, Lampe EW, Juarascio AS. Self-regulation deficits moderate treatment outcomes in a clinical trial evaluating just-in-time adaptive interventions as an augmentation to cognitive-behavioral therapy for bulimia-spectrum eating disorders. Int J Eat Disord. 2022 May;55(5):709-716. doi: 10.1002/eat.23695. Epub 2022 Feb 24.
citation: Presseller EK, Lampe EW, Michael ML, Trainor C, Fan SC, Juarascio AS. Latent trajectories of symptom change during cognitive-behavior therapy predict post-treatment worsening of symptoms: a preliminary examination among outpatients with bulimia-spectrum eating disorders. Eat Weight Disord. 2022 Aug;27(6):2257-2264. doi: 10.1007/s40519-021-01348-5. Epub 2022 Jan 4.
citation: Parker MN, Wilkinson ML, Hunt RA, Ortiz A, Manasse SM, Juarascio AS. Eating expectancies and hedonic hunger among individuals with bulimia-spectrum eating disorders who plan binge-eating episodes. Int J Eat Disord. 2022 Jan;55(1):120-124. doi: 10.1002/eat.23628. Epub 2021 Oct 13.