Self-Guided Personalized Treatment for Women

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.

Study Overview

• Status: Completed
• Conditions: Disordered Eating
• Intervention / Treatment: Behavioral: Self-guided Personalized Treatment

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40205-1016
      • Eating Anxiety Treatment Laboratory and Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Personalized Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disordered eating symptoms	Changes in disordered eating symptoms will be assessed with the Eating Disorder Examination Questionnaire-6 (EDE-Q6)	Up to 8 weeks
Anxiety	Changes in anxiety will be assessed with the Penn State Worry Questionnaire (PSWQ)	Up to 8 weeks
Depression	Changes in depression will be assessed with the Beck Depression Inventory-2 (BDI-2)	Up to 8 weeks
Clinical Impairment	Changes in clinical impairment will be assessed with the Clinical Impairment Assessment (CIA)	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Changes in quality of life will be assessed with the Quality of Life Scale (QOLS)	Up to 8 weeks

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Cheri A Levinson, University of Louisville

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Actual): March 6, 2026
• Study Completion (Actual): March 6, 2026

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Treatment; Therapy; Bulimia Nervosa; Anorexia Nervosa; Binge Eating Disorder; Atypical Anorexia Nervosa; Other specified feeding and eating disorder
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Binge-Eating Disorder; Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa
• Other Study ID Numbers: IRB#23.0274; 5P20GM103436-23 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No