A Novel Intervention Promoting Eating Disorder Treatment Among College Students

NCT ID: NCT02284685

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Eating Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A (opt-out, loss, social norming)

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).

Group Type EXPERIMENTAL

Promoting Eating Disorder Treatment among College Students

Intervention Type BEHAVIORAL

Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders

B (opt-out, gain, social norming)

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).

Group Type EXPERIMENTAL

Promoting Eating Disorder Treatment among College Students

Intervention Type BEHAVIORAL

Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders

C (opt-out, loss, no social norming)

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).

Group Type EXPERIMENTAL

Promoting Eating Disorder Treatment among College Students

Intervention Type BEHAVIORAL

Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders

D (opt-out, gain, no social norming)

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).

Group Type EXPERIMENTAL

Promoting Eating Disorder Treatment among College Students

Intervention Type BEHAVIORAL

Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders

E (opt-in, loss, social norming)

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).

Group Type EXPERIMENTAL

Promoting Eating Disorder Treatment among College Students

Intervention Type BEHAVIORAL

Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders

F (opt-in, gain, social norming)

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).

Group Type EXPERIMENTAL

Promoting Eating Disorder Treatment among College Students

Intervention Type BEHAVIORAL

Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders

G (opt-in, loss, no social norming)

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).

Group Type EXPERIMENTAL

Promoting Eating Disorder Treatment among College Students

Intervention Type BEHAVIORAL

Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders

H (opt-in, gain, no social norming)

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).

Group Type EXPERIMENTAL

Promoting Eating Disorder Treatment among College Students

Intervention Type BEHAVIORAL

Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Promoting Eating Disorder Treatment among College Students

Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Undergraduate at participating university
* Untreated symptoms of an eating disorder (as identified in an online screen)

Exclusion Criteria

* Less than 18 years of age
* Studying abroad during study period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sarah Ketchen Lipson

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarah K Lipson, MEd

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Bard College

Annandale-on-Hudson, New York, United States

Site Status

Appalachian State University

Boone, North Carolina, United States

Site Status

Mercyhurst University

Erie, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1F31MH105149-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F037058

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Online Relapse Prevention Study
NCT04862247 COMPLETED NA
Eating Disorders Among Adolescents
NCT05722470 NOT_YET_RECRUITING
Outcomes of a Skill-Based Program for Eating Disorders
NCT02852538 ENROLLING_BY_INVITATION NA