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
|Condition or disease||Intervention/treatment||Phase|
|Bulimia Nervosa Bulimia Binge Eating Purging Eating Disorder||Behavioral: CBT+ application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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+
- 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
- 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.
- 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.
- 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.
- 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.
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
|Contact: Research Coordinator||(215) 553-7130||EDresearch@drexel.edu|
|United States, Pennsylvania|
|Drexel University, Stratton Hall||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Research Coordinator 215-553-7130 EDresearch@drexel.edu|