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

Primary Purpose

Bulimia Nervosa, Bulimia, Binge Eating

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT+ application
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring Bulimia Nervosa, Eating Disorder, Binge Eating, Bulimia, Purging

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Drexel University, Stratton Hall

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT with smartphone application (EMI on)

Arm Description

CBT with CBT+ smartphone application (EMI on)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Eating Disorder Examination Questionnaire (EDE-Q)
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.
Difficulties in Emotion Regulation Scale (DERS)
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.
Technology Acceptance Model Scale (TAMS)
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.
Feedback Questionnaire (FQ)
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.

Full Information

First Posted
September 12, 2018
Last Updated
September 21, 2021
Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03673540
Brief Title
Acquisition and Utilization of Skills Using Innovative Smartphone Application for Regular Eating
Acronym
ACQUIRE
Official Title
Using Ecological Momentary Interventions to Increase Skill Acquisition and Utilization
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Bulimia, Binge Eating, Purging, Eating Disorder
Keywords
Bulimia Nervosa, Eating Disorder, Binge Eating, Bulimia, Purging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT with smartphone application (EMI on)
Arm Type
Experimental
Arm Description
CBT with CBT+ smartphone application (EMI on)
Intervention Type
Behavioral
Intervention Name(s)
CBT+ application
Other Intervention Name(s)
CBT+
Intervention Description
Smartphone application that comprises electronic self-monitoring of food intake, eating disorder behaviors, and mood and ecological momentary interventions
Primary Outcome Measure Information:
Title
Binge and purge frequency assessed by the Eating Disorder Examination
Description
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
Time Frame
Change from baseline assessment (before beginning treatment) to post-treatment assessment (16 weeks after baseline assessment)
Secondary Outcome Measure Information:
Title
Eating Disorder Examination Questionnaire (EDE-Q)
Description
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.
Time Frame
Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
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.
Time Frame
Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Title
Technology Acceptance Model Scale (TAMS)
Description
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.
Time Frame
Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Title
Feedback Questionnaire (FQ)
Description
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.
Time Frame
Assessed at weekly treatment sessions throughout treatment duration (16 weeks)

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Drexel University, Stratton Hall
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35212017
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.
Results Reference
derived
PubMed Identifier
34981464
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.
Results Reference
derived
PubMed Identifier
34643949
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.
Results Reference
derived
Links:
URL
http://drexel.edu/coas/academics/departments-centers/well-center/research/current-research-projects/
Description
For more information, send an email to EDresearch@drexel.edu or call (215) 553-7130

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

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