Disordered Eating Clinical Trial
Official title:
Personalizing Disordered Eating Treatment Using Mobile Technology: Self-Guided, Personalized Treatment for Women
The investigators plan to collect preliminary data on the feasibility, acceptability, and user uptake of a personalized self-guided mobile intervention for disordered eating (DE) and test the initial clinical efficacy of this intervention. Women (N=50) who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones. The investigators will assess engagement with the modules throughout two months and administer baseline, week 5, and week 8 assessments for acceptability, uptake, and initial clinical efficacy (e.g., DE symptoms, anxiety, quality of life). The investigators will also complete a focus group (n=10) with a subset of users to receive input on the mobile-application assessment and ease of self-guided intervention modules.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | March 15, 2025 |
Est. primary completion date | March 15, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Endorse disordered eating (score of 2.3 or above on EDE-Q6) - Age 18-65 - Ability to read and write English - Own a smartphone or tablet Exclusion Criteria: - Active mania - Active suicidality - Active psychosis |
Country | Name | City | State |
---|---|---|---|
United States | Eating Anxiety Treatment Laboratory and Clinic | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville | National Institute of General Medical Sciences (NIGMS) |
United States,
Borsboom D, Cramer AO. Network analysis: an integrative approach to the structure of psychopathology. Annu Rev Clin Psychol. 2013;9:91-121. doi: 10.1146/annurev-clinpsy-050212-185608. — View Citation
Levinson CA, Hunt RA, Keshishian AC, Brown ML, Vanzhula I, Christian C, Brosof LC, Williams BM. Using individual networks to identify treatment targets for eating disorder treatment: a proof-of-concept study and initial data. J Eat Disord. 2021 Nov 4;9(1):147. doi: 10.1186/s40337-021-00504-7. Erratum In: J Eat Disord. 2022 Jul 11;10(1):99. — View Citation
Levinson CA, Williams BM, Christian C, Hunt RA, Keshishian AC, Brosof LC, Vanzhula IA, Davis GG, Brown ML, Bridges-Curry Z, Sandoval-Araujo LE, Ralph-Nearman C. Personalizing eating disorder treatment using idiographic models: An open series trial. J Consult Clin Psychol. 2023 Jan;91(1):14-28. doi: 10.1037/ccp0000785. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disordered eating symptoms | Changes in disordered eating symptoms will be assessed with the Eating Disorder Examination Questionnaire-6 (EDE-Q6) | Up to 8 weeks | |
Primary | Anxiety | Changes in anxiety will be assessed with the Penn State Worry Questionnaire (PSWQ) | Up to 8 weeks | |
Primary | Depression | Changes in depression will be assessed with the Beck Depression Inventory-2 (BDI-2) | Up to 8 weeks | |
Primary | Clinical Impairment | Changes in clinical impairment will be assessed with the Clinical Impairment Assessment (CIA) | Up to 8 weeks | |
Primary | Quality of life | Changes in quality of life will be assessed with the Quality of Life Scale (QOLS) | Up to 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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