Eating DisordersPhase 1NCT02284685
A Novel Intervention Promoting Eating Disorder Treatment Among College Students
A Phase 1 study testing Promoting Eating Disorder Treatment among College Students in people with Eating Disorders, run by University of Michigan at 4 sites in United States.
Trial summary
Eating disorders (EDs) have the highest rate of mortality of any mental illness. On U.S. college campuses, an estimated 80% students with clinically significant ED symptoms do not receive treatment. There are likely more than one million students whose EDs go untreated in any given year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Promoting Eating Disorder Treatment among College Students
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,149 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2015to May 2015
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergraduate at participating university
- Untreated symptoms of an eating disorder (as identified in an online screen)
Who cannot join
- Less than 18 years of age
- Studying abroad during study period
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48104
Bard College
Annandale-on-Hudson, New York, 12504
Appalachian State University
Boone, North Carolina, 28608
Mercyhurst University
Erie, Pennsylvania, 16546
About this study
Eating disorders (EDs) have the highest rate of mortality of any mental illness. On U.S. college campuses, an estimated 80% students with clinically significant ED symptoms do not receive treatment. There are likely more than one million students whose EDs go untreated in any given year. Left untreated EDs typically become more severe and refractory to treatment. Given the impact of EDs on mental and physical health and the connection therein with social, academic, and economic outcomes, an effective intervention to increase rates of treatment utilization would have broad societal effects extending well beyond the campus setting. This study is an online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated EDs.
Read the detailed description
Eating disorders (EDs) have the highest rate of mortality of any mental illness. ED age of onset coincides with the undergraduate years (ages 18-25). As such, colleges provide access to a large, epidemiologically vulnerable population and present a unique opportunity for intervention. On college campuses, 14% of female and 4% of male students screen positive for clinically significant EDs. An estimated 80% of these students do not receive treatment. Left untreated EDs typically become more severe and refractory to treatment. Help-seeking interventions typically focus on minimizing stigma, improving knowledge, and addressing other barriers emphasized by classic theories of health behavior. On the whole, these interventions have failed to increase treatment utilization for the vast majority of students with ED symptoms. Innovative approaches are urgently needed to narrow the ED treatment gap on college campuses.
The proposed study builds on the most comprehensive research to date on mental health service utilization in college populations, which the Principal Investigator of this study (PI) has developed with her faculty advisor. Findings reveal new insight into the ED treatment gap: students with untreated EDs report not seeking help for reasons such as lack of time, lack of perceived need, ambivalence about the severity of need, belief that the problem will resolve itself without treatment, and a desire to deal with issues "on my own." These reasons imply a lack of urgency but not necessarily a strong resistance to receiving treatment. In similar health contexts (e.g., for diet/exercise, use of preventative care), behavioral economic interventions have produced positive results by addressing several cognitive biases, including the default bias (individuals 'go with the flow' of preset options) and the sign effect (losses (negative outcomes) are substantially more psychologically costly than gains (positive outcomes)). The present intervention study addresses these biases in an effort to increase service use among undergraduate students with untreated ED symptoms (as identified in an online screen).
In a 12-week study, the study team is using a factorial design to test the effects of three intervention components: peer norming, default option, and sign effect. The intervention components are delivered via email messaging. To address the default bias, email messages reframe treatment use as an opt-out (as opposed to opt-in) behavior, thus nudging students to seek help. Students are able to check a box to opt out of receiving treatment linkage. Those who do not opt-out receive, without any purposeful action, continued assistance connecting to treatment. For the sign effect, messages emphasize the negative consequences of untreated EDs to engender urgency. Students in conditions with peer norming see how their levels of eating disorder symptoms (results from widely-used, validated measures included in the baseline survey) compare with average symptom levels among other undergraduates (with data taken from national surveys previously conducted by the study team). Follow-up data is being collected at weeks 6 and 12. Intervention components are operationalized in electronic messages delivered over 12-weeks (anticipated: January-May 2015).
- Conditions
- Eating Disorders
- Being tested
- Promoting Eating Disorder Treatment among College Students
- Keywords
- Mental Health Services
- 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.
Promoting Eating Disorder Treatment among College StudentsBehavioural
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
| Study group | Role | What they receive |
|---|---|---|
| A (opt-out, loss, social norming) | Experimental | Students in this intervention arm must opt-out of receiving linkage to eating disorder resources on their campus; messages include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the negative consequences (losses) of not seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-out, loss, social norming). Receives: Behavioral: Promoting Eating Disorder Treatment among College Students |
| B (opt-out, gain, social norming) | Experimental | Students in this intervention arm must opt-out of receiving linkage to eating disorder resources on their campus; messages include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the benefits of seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-out, gain, social norming). Receives: Behavioral: Promoting Eating Disorder Treatment among College Students |
| C (opt-out, loss, no social norming) | Experimental | Students in this intervention arm must opt-out of receiving linkage to eating disorder resources on their campus; messages do not include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the negative consequences (losses) of not seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-out, loss, no social norming). Receives: Behavioral: Promoting Eating Disorder Treatment among College Students |
| D (opt-out, gain, no social norming) | Experimental | Students in this intervention arm must opt-out of receiving linkage to eating disorder resources on their campus; messages do not include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the benefits of seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-out, gain, no social norming). Receives: Behavioral: Promoting Eating Disorder Treatment among College Students |
| E (opt-in, loss, social norming) | Experimental | Students in this intervention arm must opt-in to receiving linkage to eating disorder resources on their campus; messages include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the negative consequences (losses) of not seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-in, loss, social norming). Receives: Behavioral: Promoting Eating Disorder Treatment among College Students |
| F (opt-in, gain, social norming) | Experimental | Students in this intervention arm must opt-in to receiving linkage to eating disorder resources on their campus; messages include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the benefits of seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-in, gain, social norming). Receives: Behavioral: Promoting Eating Disorder Treatment among College Students |
| G (opt-in, loss, no social norming) | Experimental | Students in this intervention arm must opt-in to receiving linkage to eating disorder resources on their campus; messages do not include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the negative consequences (losses) of not seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-in, loss, no social norming). Receives: Behavioral: Promoting Eating Disorder Treatment among College Students |
| H (opt-in, gain, no social norming) | Experimental | Students in this intervention arm must opt-in to receiving linkage to eating disorder resources on their campus; messages do not include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the benefits of seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-in, gain, no social norming). Receives: Behavioral: Promoting Eating Disorder Treatment among College Students |
What is being measured
The primary outcome is the main question the study is designed to answer.
Help-seeking behavior (Use of services (e.g., counseling/therapy) for eating and body image issues)
Use of services (e.g., counseling/therapy) for eating and body image issues
Measured: 12 weeks
Secondary outcomes (1)
Predictors of help-seeking behavior (e.g., perceived need/urgency, knowledge, attitudes, intentions to seek help)
Predictors of help-seeking behavior (e.g., perceived need/urgency, knowledge, attitudes, intentions to seek help)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sarah Ketchen Lipson, University of Michigan
- Investigators
- Sarah K Lipson, MEd, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284685
- Sponsor's protocol ID
- F037058
- Other IDs
- 1F31MH105149-01
- Status last verified
- May 2015
- First submitted
- 3 Nov 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Intervention Promoting Eating Disorder Treatment Among College Students
- ClinicalTrials.gov ID
- NCT02284685
- Acronym / sponsor ID
- F037058
- Conditions
- Eating Disorders
- Keywords
- Mental Health Services
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,149 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Nov 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.
Eating disorders (EDs) have the highest rate of mortality of any mental illness. On U.S. college campuses, an estimated 80% students with clinically significant ED symptoms do not receive treatment. There are likely more than one million students whose EDs go untreated in any given year. Left untreated EDs typically become more severe and refractory to treatment. Given the impact of EDs on mental and physical health and the connection therein with social, academic, and economic outcomes, an effective intervention to increase rates of treatment utilization would have broad societal effects extending well beyond the campus setting. This study is an online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated EDs.
Detailed description
Eating disorders (EDs) have the highest rate of mortality of any mental illness. ED age of onset coincides with the undergraduate years (ages 18-25). As such, colleges provide access to a large, epidemiologically vulnerable population and present a unique opportunity for intervention. On college campuses, 14% of female and 4% of male students screen positive for clinically significant EDs. An estimated 80% of these students do not receive treatment. Left untreated EDs typically become more severe and refractory to treatment. Help-seeking interventions typically focus on minimizing stigma, improving knowledge, and addressing other barriers emphasized by classic theories of health behavior. On the whole, these interventions have failed to increase treatment utilization for the vast majority of students with ED symptoms. Innovative approaches are urgently needed to narrow the ED treatment gap on college campuses.
The proposed study builds on the most comprehensive research to date on mental health service utilization in college populations, which the Principal Investigator of this study (PI) has developed with her faculty advisor. Findings reveal new insight into the ED treatment gap: students with untreated EDs report not seeking help for reasons such as lack of time, lack of perceived need, ambivalence about the severity of need, belief that the problem will resolve itself without treatment, and a desire to deal with issues "on my own." These reasons imply a lack of urgency but not necessarily a strong resistance to receiving treatment. In similar health contexts (e.g., for diet/exercise, use of preventative care), behavioral economic interventions have produced positive results by addressing several cognitive biases, including the default bias (individuals 'go with the flow' of preset options) and the sign effect (losses (negative outcomes) are substantially more psychologically costly than gains (positive outcomes)). The present intervention study addresses these biases in an effort to increase service use among undergraduate students with untreated ED symptoms (as identified in an online screen).
In a 12-week study, the study team is using a factorial design to test the effects of three intervention components: peer norming, default option, and sign effect. The intervention components are delivered via email messaging. To address the default bias, email messages reframe treatment use as an opt-out (as opposed to opt-in) behavior, thus nudging students to seek help. Students are able to check a box to opt out of receiving treatment linkage. Those who do not opt-out receive, without any purposeful action, continued assistance connecting to treatment. For the sign effect, messages emphasize the negative consequences of untreated EDs to engender urgency. Students in conditions with peer norming see how their levels of eating disorder symptoms (results from widely-used, validated measures included in the baseline survey) compare with average symptom levels among other undergraduates (with data taken from national surveys previously conducted by the study team). Follow-up data is being collected at weeks 6 and 12. Intervention components are operationalized in electronic messages delivered over 12-weeks (anticipated: January-May 2015).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A (opt-out, loss, social norming) | Experimental | Behavioral: Promoting Eating Disorder Treatment among College StudentsStudents in this intervention arm must opt-out of receiving linkage to eating disorder resources on their campus; messages include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the negative consequences (losses) of not seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-out, loss, social norming). |
| B (opt-out, gain, social norming) | Experimental | Behavioral: Promoting Eating Disorder Treatment among College StudentsStudents in this intervention arm must opt-out of receiving linkage to eating disorder resources on their campus; messages include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the benefits of seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-out, gain, social norming). |
| C (opt-out, loss, no social norming) | Experimental | Behavioral: Promoting Eating Disorder Treatment among College StudentsStudents in this intervention arm must opt-out of receiving linkage to eating disorder resources on their campus; messages do not include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the negative consequences (losses) of not seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-out, loss, no social norming). |
| D (opt-out, gain, no social norming) | Experimental | Behavioral: Promoting Eating Disorder Treatment among College StudentsStudents in this intervention arm must opt-out of receiving linkage to eating disorder resources on their campus; messages do not include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the benefits of seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-out, gain, no social norming). |
| E (opt-in, loss, social norming) | Experimental | Behavioral: Promoting Eating Disorder Treatment among College StudentsStudents in this intervention arm must opt-in to receiving linkage to eating disorder resources on their campus; messages include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the negative consequences (losses) of not seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-in, loss, social norming). |
| F (opt-in, gain, social norming) | Experimental | Behavioral: Promoting Eating Disorder Treatment among College StudentsStudents in this intervention arm must opt-in to receiving linkage to eating disorder resources on their campus; messages include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the benefits of seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-in, gain, social norming). |
| G (opt-in, loss, no social norming) | Experimental | Behavioral: Promoting Eating Disorder Treatment among College StudentsStudents in this intervention arm must opt-in to receiving linkage to eating disorder resources on their campus; messages do not include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the negative consequences (losses) of not seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-in, loss, no social norming). |
| H (opt-in, gain, no social norming) | Experimental | Behavioral: Promoting Eating Disorder Treatment among College StudentsStudents in this intervention arm must opt-in to receiving linkage to eating disorder resources on their campus; messages do not include social norming (statistics comparing their rates of eating disorder symptoms to national averages on widely-used and clinically validated screening tools); and messages frame the benefits of seeking-help for current disordered eating symptoms. The intervention ('A Novel Intervention Promoting Eating Disorder Treatment among College Students') is this version of the email messages (opt-in, gain, no social norming). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergraduate at participating university
- Untreated symptoms of an eating disorder (as identified in an online screen)
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Studying abroad during study period
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 |
|---|---|---|
| Promoting Eating Disorder Treatment among College StudentsOnline intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders | Behavioural | A (opt-out, loss, social norming), B (opt-out, gain, social norming), C (opt-out, loss, no social norming), D (opt-out, gain, no social norming), E (opt-in, loss, social norming), F (opt-in, gain, social norming), G (opt-in, loss, no social norming), H (opt-in, gain, no social norming) |
Primary outcome
Help-seeking behavior (Use of services (e.g., counseling/therapy) for eating and body image issues)
Time frame: 12 weeks
Use of services (e.g., counseling/therapy) for eating and body image issues
1 secondary outcome
Predictors of help-seeking behavior (e.g., perceived need/urgency, knowledge, attitudes, intentions to seek help)
Time frame: 12 weeks
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 28 May 2015.
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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.
Sarah K Lipson, MEd principal investigator
University of Michigan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Promoting Eating Disorder Treatment among College Students in people with Eating Disorders, run by University of Michigan at 4 sites in United States.
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 2 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Help-seeking behavior (Use of services (e.g., counseling/therapy) for eating and body image issues) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2015.