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Clinical Trials/NCT05920720
NCT05920720
Not yet recruiting
Not Applicable

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

University of Louisville1 site in 1 country50 target enrollmentFebruary 28, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disordered Eating
Sponsor
University of Louisville
Enrollment
50
Locations
1
Primary Endpoint
Clinical Impairment
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2025
End Date
August 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cheri Levinson

Director

University of Louisville

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinical Impairment

Time Frame: Up to 8 weeks

Changes in clinical impairment will be assessed with the Clinical Impairment Assessment (CIA)

Anxiety

Time Frame: Up to 8 weeks

Changes in anxiety will be assessed with the Penn State Worry Questionnaire (PSWQ)

Depression

Time Frame: Up to 8 weeks

Changes in depression will be assessed with the Beck Depression Inventory-2 (BDI-2)

Disordered eating symptoms

Time Frame: Up to 8 weeks

Changes in disordered eating symptoms will be assessed with the Eating Disorder Examination Questionnaire-6 (EDE-Q6)

Quality of life

Time Frame: Up to 8 weeks

Changes in quality of life will be assessed with the Quality of Life Scale (QOLS)

Study Sites (1)

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