Self-Guided Personalized Treatment for Women

Sponsor
University of Louisville (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05920720
Collaborator
National Institute of Mental Health (NIMH) (NIH)
50
1
1
8
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self-guided Personalized Treatment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Personalizing Disordered Eating Treatment Using Mobile Technology: Self-Guided, Personalized Treatment for Women
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Disordered eating symptoms [Up to 8 weeks]

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

    2. Anxiety [Up to 8 weeks]

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

    3. Depression [Up to 8 weeks]

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

    4. Clinical Impairment [Up to 8 weeks]

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

    5. Quality of life [Up to 8 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eating Anxiety Treatment Laboratory and Clinic Louisville Kentucky United States 40205-1016

    Sponsors and Collaborators

    • University of Louisville
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Cheri A Levinson, University of Louisville

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cheri Levinson, Director, University of Louisville
    ClinicalTrials.gov Identifier:
    NCT05920720
    Other Study ID Numbers:
    • IRB#23.0274
    First Posted:
    Jun 27, 2023
    Last Update Posted:
    Jun 27, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cheri Levinson, Director, University of Louisville

    Study Results

    No Results Posted as of Jun 27, 2023