NCT05920720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

June 9, 2023

Last Update Submit

April 28, 2026

Conditions

Disordered Eating

Keywords

TreatmentTherapyAnorexia NervosaBulimia NervosaBinge Eating DisorderAtypical Anorexia NervosaOther specified feeding and eating disorder

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Quality of life

    Up to 8 weeks

Study Arms (1)

Self-guided Personalized Treatment

EXPERIMENTAL

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

Interventions

Self-guided Personalized TreatmentBEHAVIORAL

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.

Also known as: Personalized Treatment
Self-guided Personalized Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants will be self-identified women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Active mania
  • Active suicidality
  • Active psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eating Anxiety Treatment Laboratory and Clinic

Louisville, Kentucky, 40205-1016, United States

Location

Related Publications (3)

  • 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.

    PMID: 36729494BACKGROUND

  • 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.

    PMID: 23537483BACKGROUND

  • 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.

    PMID: 34736538BACKGROUND

MeSH Terms

Conditions

Anorexia NervosaBulimia NervosaBinge-Eating DisorderFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cheri A Levinson

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 27, 2023

Study Start

February 28, 2025

Primary Completion

March 6, 2026

Study Completion

March 6, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)