Using Technology to Improve Eating Disorders Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02076464|
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Eating Disorders||Behavioral: StudentBodies - Eating Disorders||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||690 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using Technology to Improve Eating Disorders Treatment|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||November 27, 2018|
|Actual Study Completion Date :||November 27, 2018|
Experimental: StudentBodies - Eating Disorders
Participants will participate in the StudentBodies - Eating Disorders program
Behavioral: StudentBodies - Eating Disorders
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.
No Intervention: Usual Care
Participants will be referred to treatment per protocol at students' corresponding college's mental health services center
- Change in eating disorder symptoms [ Time Frame: Measured at baseline, 6-months, 1-year, and 2-years ]Eating disorder outcomes will be measured using the Eating Disorder Examination Questionnaire
- Realized treatment access [ Time Frame: 2 years ]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 [ Time Frame: 2 years ]Rates of bingeing and purging will be measured using the Eating Disorder Examination Questionnaire
- Comorbid symptom severity and impairment [ Time Frame: 2 years ]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 [ Time Frame: up to 5 years ]Service and implementation costs will be assessed based on published rates.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076464
|Principal Investigator:||Denise E. Wilfley, Ph.D.||Washington University School of Medicine|
|Principal Investigator:||C. Barr Taylor, M.D.||Stanford University|