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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05920720
Other study ID # IRB#23.0274
Secondary ID 5P20GM103436-23
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date March 15, 2025

Study information

Verified date April 2024
Source University of Louisville
Contact Cheri A Levinson, PhD
Phone 502-852-7710
Email cheri.levinson@louisville.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Self-guided Personalized Treatment
Women 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.

Locations

Country Name City State
United States Eating Anxiety Treatment Laboratory and Clinic Louisville Kentucky

Sponsors (2)

Lead Sponsor Collaborator
University of Louisville National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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
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