Self-Guided Personalized Treatment for Women

Disordered Eating Clinical Trial

Official title:

Personalizing Disordered Eating Treatment Using Mobile Technology: Self-Guided, Personalized Treatment for Women

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
• 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
• 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

Related Conditions & MeSH terms

• Disordered Eating

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