Using Technology to Improve Eating Disorders Treatment

Eating Disorders Clinical Trial

Official title:

Using Technology to Improve Eating Disorders Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076464
• Other study ID #: R01MH100455
• Secondary ID: 5R01MH100455
• Status: Completed
• Phase: N/A
• Start date: January 12, 2014
• Est. completion date: November 27, 2018

Study information

• Verified date: November 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce eating disorder outcomes in college-age women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Eating Disorders
• Feeding and Eating Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH), Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in eating disorder symptoms	Eating disorder outcomes will be measured using the Eating Disorder Examination Questionnaire	Measured at baseline, 6-months, 1-year, and 2-years
Secondary	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	2 years
Secondary	Eating disorder behavior abstinence rates	Rates of bingeing and purging will be measured using the Eating Disorder Examination Questionnaire	2 years
Secondary	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).	2 years
Secondary	Service and implementation costs	Service and implementation costs will be assessed based on published rates.	up to 5 years