Self-Guided Personalized Treatment for Women

Not Applicable

Not yet recruiting

• Conditions: Disordered Eating

• Registration Number: NCT05920720
• Lead Sponsor: University of Louisville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-16
• Study First Posted: 2023-06-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Study Start: 2025-02-28
• Primary Completion: 2025-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical Impairment	Up to 8 weeks	Changes in clinical impairment will be assessed with the Clinical Impairment Assessment (CIA)
Anxiety	Up to 8 weeks	Changes in anxiety will be assessed with the Penn State Worry Questionnaire (PSWQ)
Depression	Up to 8 weeks	Changes in depression will be assessed with the Beck Depression Inventory-2 (BDI-2)
Disordered eating symptoms	Up to 8 weeks	Changes in disordered eating symptoms will be assessed with the Eating Disorder Examination Questionnaire-6 (EDE-Q6)
Quality of life	Up to 8 weeks	Changes in quality of life will be assessed with the Quality of Life Scale (QOLS)

Trial Locations

Locations (1)

Eating Anxiety Treatment Laboratory and Clinic; 🇺🇸 Louisville, Kentucky, United States