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
About this trial
This is an interventional other trial for Eating Disorders
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
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
NCT ID
NCT02076464
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
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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Using Technology to Improve Eating Disorders Treatment
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