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

September 21, 2021 updated by: Drexel University

Using Ecological Momentary Interventions to Increase Skill Acquisition and Utilization

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Drexel University, Stratton Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CBT with smartphone application (EMI on)
CBT with CBT+ smartphone application (EMI on)
Behavioral: CBT+ application
Smartphone application that comprises electronic self-monitoring of food intake, eating disorder behaviors, and mood and ecological momentary interventions
Other Names:
  • CBT+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: 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.
Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: 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.
Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Technology Acceptance Model Scale (TAMS)
Time Frame: 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.
Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Feedback Questionnaire (FQ)
Time Frame: 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.
Assessed at weekly treatment sessions throughout treatment duration (16 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2018

Primary Completion (ACTUAL)

January 15, 2021

Study Completion (ACTUAL)

January 15, 2021

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (ACTUAL)

September 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1802006074
  • R34MH116021 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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