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

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ClinicalTrials.gov Identifier: NCT03673540
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bulimia Nervosa Bulimia Binge Eating Purging Eating Disorder Behavioral: CBT+ application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Ecological Momentary Interventions to Increase Skill Acquisition and Utilization
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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 Name: CBT+




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673540


Contacts
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Contact: Research Coordinator (215) 553-7130 EDresearch@drexel.edu

Locations
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United States, Pennsylvania
Drexel University, Stratton Hall Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Research Coordinator    215-553-7130    EDresearch@drexel.edu   
Sponsors and Collaborators
Drexel University
National Institute of Mental Health (NIMH)

Additional Information:
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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT03673540     History of Changes
Other Study ID Numbers: 1802006074
R34MH116021 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Drexel University:
Bulimia Nervosa
Eating Disorder
Binge Eating
Bulimia
Purging
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms