Eating DisordersNCT02076464
Using Technology to Improve Eating Disorders Treatment
A study testing StudentBodies - Eating Disorders in people with Eating Disorders, run by Washington University School of Medicine.
Trial summary
The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce eating disorder outcomes in college-age women. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Eating Disorders
- What is being tested?
- StudentBodies - Eating Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2014to 27 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Screen positive for DSM-5 anorexia nervosa
- No access to the internet
- Acutely suicidal
About this study
The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce eating disorder outcomes in college-age women.
Read the 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.
- Conditions
- Eating Disorders
- Being tested
- StudentBodies - Eating Disorders
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StudentBodies - Eating DisordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| StudentBodies - Eating Disorders | Experimental | Participants will participate in the StudentBodies - Eating Disorders program Receives: Behavioral: StudentBodies - Eating Disorders |
| Usual Care | No intervention | Participants will be referred to treatment per protocol at students' corresponding college's mental health services center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eating disorder symptoms
Eating disorder outcomes will be measured using the Eating Disorder Examination Questionnaire
Measured: Measured at baseline, 6-months, 1-year, and 2-years
Secondary outcomes (4)
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
Measured: 2 years
Eating disorder behavior abstinence rates
Rates of bingeing and purging will be measured using the Eating Disorder Examination Questionnaire
Measured: 2 years
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).
Measured: 2 years
Service and implementation costs
Service and implementation costs will be assessed based on published rates.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start12 Jan 2014
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Stanford University
- Responsible party
- Principal investigator, Denise Wilfley, Washington University School of Medicine
- Investigators
- Denise E. Wilfley, Ph.D., Principal investigator, Washington University School of MedicineC. Barr Taylor, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076464
- Sponsor's protocol ID
- R01MH100455
- Other IDs
- 5R01MH100455
- Status last verified
- Nov 2019
- First submitted
- 26 Feb 2014
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Graham AK, Fitzsimmons-Craft EE, Sadeh-Sharvit S, Balantekin KN, Eichen DM, Firebaugh ML, Goel NJ, Monterubio GE, Karam AM, Flatt RE, Jo B, Jacobi C, Wilfley DE, Taylor CB, Trockel M. Moderators and mediators of a digital cognitive behavior therapy-guided self-help intervention for eating disorders: Informing future design efforts. J Consult Clin Psychol. 2023 May;91(5):280-284. doi: 10.1037/ccp0000786. Epub 2023 Jan 12.
PubMed 36634022Fitzsimmons-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.
PubMed 32865576
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technology to Improve Eating Disorders Treatment
- ClinicalTrials.gov ID
- NCT02076464
- Acronym / sponsor ID
- R01MH100455
- Conditions
- Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Stanford University
- Study start
- 12 Jan 2014 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StudentBodies - Eating Disorders | Experimental | Behavioral: StudentBodies - Eating DisordersParticipants will participate in the StudentBodies - Eating Disorders program |
| Usual Care | No intervention | –Participants will be referred to treatment per protocol at students' corresponding college's mental health services center |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Screen positive for DSM-5 anorexia nervosa
- No access to the internet
- Acutely suicidal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StudentBodies - Eating DisordersThe 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. | Behavioural | StudentBodies - Eating Disorders |
Primary outcome
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
4 secondary outcomes
Realized treatment access
Time frame: 2 years
Eating disorder behavior abstinence rates
Time frame: 2 years
Comorbid symptom severity and impairment
Time frame: 2 years
Service and implementation costs
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Derived from this study: PubMed 36634022Graham AK, Fitzsimmons-Craft EE, Sadeh-Sharvit S, Balantekin KN, Eichen DM, Firebaugh ML, Goel NJ, Monterubio GE, Karam AM, Flatt RE, Jo B, Jacobi C, Wilfley DE, Taylor CB, Trockel M. Moderators and mediators of a digital cognitive behavior therapy-guided self-help intervention for eating disorders: Informing future design efforts. J Consult Clin Psychol. 2023 May;91(5):280-284. doi: 10.1037/ccp0000786. Epub 2023 Jan 12.
- Derived from this study: PubMed 32865576Fitzsimmons-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise E. Wilfley, Ph.D. principal investigator
Washington University School of Medicine
C. Barr Taylor, M.D. principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing StudentBodies - Eating Disorders in people with Eating Disorders, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eating disorder symptoms (time frame: Measured at baseline, 6-months, 1-year, and 2-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02076464, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.