NCT03673540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

September 12, 2018

Last Update Submit

September 21, 2021

Conditions

Bulimia NervosaBulimiaBinge EatingPurgingEating Disorder

Keywords

Bulimia NervosaEating DisorderBinge EatingBulimiaPurging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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)

Study Arms (1)

CBT with smartphone application (EMI on)

EXPERIMENTAL

CBT with CBT+ smartphone application (EMI on)

Behavioral: CBT+ application

Interventions

CBT+ applicationBEHAVIORAL

Smartphone application that comprises electronic self-monitoring of food intake, eating disorder behaviors, and mood and ecological momentary interventions

Also known as: CBT+
CBT with smartphone application (EMI on)

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University, Stratton Hall

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

  • 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.

    PMID: 35212017DERIVED

  • 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.

    PMID: 34981464DERIVED

  • 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.

    PMID: 34643949DERIVED

Related Links

MeSH Terms

Conditions

Bulimia NervosaBulimiaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 17, 2018

Study Start

August 31, 2018

Primary Completion

January 15, 2021

Study Completion

January 15, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

US(1)