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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH116021 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT with smartphone application (EMI on) | Experimental | CBT with CBT+ smartphone application (EMI on) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT+ application | Behavioral | Smartphone application that comprises electronic self-monitoring of food intake, eating disorder behaviors, and mood and ecological momentary interventions |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline assessment (before beginning treatment) to post-treatment assessment (16 weeks after baseline assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University, Stratton Hall | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35212017 | Derived | 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. | |
| 34981464 | Derived | 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. |
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| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| D002032 | Bulimia |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| Assessed at weekly treatment sessions throughout treatment duration (16 weeks) |
| 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. | Assessed at weekly treatment sessions throughout treatment duration (16 weeks) |
| 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. | Assessed at weekly treatment sessions throughout treatment duration (16 weeks) |
| 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. | Assessed at weekly treatment sessions throughout treatment duration (16 weeks) |
| 34643949 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |