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Using Technology to Improve Eating Disorders Treatment

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
StudentBodies - Eating Disorders
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Eating Disorders

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Student at a participating college or university ages 18-30
  • Screen positive for DSM-5 bulimia nervosa, binge eating disorder, or a subclinical eating disorder

Exclusion Criteria:

  • Screen positive for DSM-5 anorexia nervosa
  • No access to the internet
  • Acutely suicidal

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    StudentBodies - Eating Disorders

    Usual Care

    Arm Description

    Participants will participate in the StudentBodies - Eating Disorders program

    Participants will be referred to treatment per protocol at students' corresponding college's mental health services center

    Outcomes

    Primary Outcome Measures

    Change in eating disorder symptoms
    Eating disorder outcomes will be measured using the Eating Disorder Examination Questionnaire

    Secondary Outcome Measures

    Realized treatment access
    Realized treatment access is defined as receipt of eating disorder treatment and will be measured using medical records (when available) and a Health Care Utilization Questionnaire
    Eating disorder behavior abstinence rates
    Rates of bingeing and purging will be measured using the Eating Disorder Examination Questionnaire
    Comorbid symptom severity and impairment
    Symptom Severity includes depression, anxiety, alcohol use, eating disorder associated clinical impairment, and academic impairment. These symptoms will be measured using the Patient Health Questionnaire, the PROMIS anxiety questionnaire, an assessment of binge drinking, the Counseling Center Assessment of Psychological Symptoms, the Clinical Impairment Assessment, and academic transcripts (when available).
    Service and implementation costs
    Service and implementation costs will be assessed based on published rates.

    Full Information

    First Posted
    February 26, 2014
    Last Updated
    November 5, 2019
    Sponsor
    Washington University School of Medicine
    Collaborators
    National Institute of Mental Health (NIMH), Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02076464
    Brief Title
    Using Technology to Improve Eating Disorders Treatment
    Official Title
    Using Technology to Improve Eating Disorders Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 12, 2014 (Actual)
    Primary Completion Date
    November 27, 2018 (Actual)
    Study Completion Date
    November 27, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Washington University School of Medicine
    Collaborators
    National Institute of Mental Health (NIMH), Stanford University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce eating disorder outcomes in college-age women.
    Detailed Description
    Colleges are faced with an elevated prevalence of eating disorders, yet less than 20% of students report receiving treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for improved modalities for screening and intervention. Over the past 20 years, we have developed a comprehensive, online platform through which we identify and offer tailored evidence-based interventions to individuals across the eating disorder risk and diagnostic spectrum, using minimal person-based resources. The newest intervention in our suite of programs, Student Bodies-Eating Disorders (SB-ED), has not yet been tested in a large-scale trial or via platform delivery. The aim of this study is to conduct the first national deployment of our comprehensive platform and demonstrate that our transdiagnostic guided self-help program, SB-ED, yields measurable and significant improvements in access, costs, and outcomes for eating disorder treatment over referral to usual care (i.e., treatment per protocol at students' corresponding college's mental health services center). Twenty-eight colleges will be randomly assigned to receive either SB-ED or referral to usual care. We will enroll at least 650 students from these campuses who screen positive for a DSM-5 clinical or subclinical eating disorder (excluding anorexia nervosa, which warrants more intensive medical monitoring). Outcomes will be measured at 6-months, 1-year, and 2-years following the completion of the online screen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorders

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    690 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    StudentBodies - Eating Disorders
    Arm Type
    Experimental
    Arm Description
    Participants will participate in the StudentBodies - Eating Disorders program
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Participants will be referred to treatment per protocol at students' corresponding college's mental health services center
    Intervention Type
    Behavioral
    Intervention Name(s)
    StudentBodies - Eating Disorders
    Intervention Description
    The intervention is a structured, cognitive-behavioral guided self-help program, derived from manual-based cognitive-behavioral therapy. The intervention targets the core eating disorder pathology (e.g., extreme dietary restraint, overvaluation of shape and weight, binge eating, compensatory behaviors), focusing on helping users develop regular eating patterns, self-control strategies, problem-solving skills, and relapse prevention tools for maintenance of behavior change. The program includes daily symptom checklists, journal exercises and activities, and an asynchronous moderated online discussion group.
    Primary Outcome Measure Information:
    Title
    Change in eating disorder symptoms
    Description
    Eating disorder outcomes will be measured using the Eating Disorder Examination Questionnaire
    Time Frame
    Measured at baseline, 6-months, 1-year, and 2-years
    Secondary Outcome Measure Information:
    Title
    Realized treatment access
    Description
    Realized treatment access is defined as receipt of eating disorder treatment and will be measured using medical records (when available) and a Health Care Utilization Questionnaire
    Time Frame
    2 years
    Title
    Eating disorder behavior abstinence rates
    Description
    Rates of bingeing and purging will be measured using the Eating Disorder Examination Questionnaire
    Time Frame
    2 years
    Title
    Comorbid symptom severity and impairment
    Description
    Symptom Severity includes depression, anxiety, alcohol use, eating disorder associated clinical impairment, and academic impairment. These symptoms will be measured using the Patient Health Questionnaire, the PROMIS anxiety questionnaire, an assessment of binge drinking, the Counseling Center Assessment of Psychological Symptoms, the Clinical Impairment Assessment, and academic transcripts (when available).
    Time Frame
    2 years
    Title
    Service and implementation costs
    Description
    Service and implementation costs will be assessed based on published rates.
    Time Frame
    up to 5 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Student at a participating college or university ages 18-30 Screen positive for DSM-5 bulimia nervosa, binge eating disorder, or a subclinical eating disorder Exclusion Criteria: Screen positive for DSM-5 anorexia nervosa No access to the internet Acutely suicidal
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Denise E. Wilfley, Ph.D.
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    C. Barr Taylor, M.D.
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32865576
    Citation
    Fitzsimmons-Craft EE, Taylor CB, Graham AK, Sadeh-Sharvit S, Balantekin KN, Eichen DM, Monterubio GE, Goel NJ, Flatt RE, Karam AM, Firebaugh ML, Jacobi C, Jo B, Trockel MT, Wilfley DE. Effectiveness of a Digital Cognitive Behavior Therapy-Guided Self-Help Intervention for Eating Disorders in College Women: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2015633. doi: 10.1001/jamanetworkopen.2020.15633.
    Results Reference
    derived

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