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OpenTrials
Completed

NCT Number: NCT05920720

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.

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Key information

Conditions

Disordered Eating Anorexia Nervosa Binge-Eating Disorder Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eating Anxiety Treatment Laboratory and Clinic

Louisville, Kentucky, 40205-1016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-guided Personalized Treatment

Behavioral

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

Primary outcomes

  1. 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)

  2. Anxiety

    Time frame: Up to 8 weeks

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

  3. Depression

    Time frame: Up to 8 weeks

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

  4. Clinical Impairment

    Time frame: Up to 8 weeks

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

Secondary outcomes

  1. Quality of life

    Time frame: Up to 8 weeks

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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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