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Completed

NCT Number: NCT03673540

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

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.

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Key information

Conditions

Bulimia Nervosa Binge Eating Bulimia Eating Disorder Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Purging Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University, Stratton Hall

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT+ application

Behavioral

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

Other names: CBT+

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Using Ecological Momentary Interventions to Increase Skill Acquisition and Utilization

Acronym: ACQUIRE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2018
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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