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A Novel Intervention Promoting Eating Disorder Treatment Among College Students

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284685
First Posted: November 6, 2014
Last Update Posted: May 28, 2015
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sarah Ketchen Lipson, University of Michigan
  Purpose
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.

Condition Intervention Phase
Eating Disorders Behavioral: Promoting Eating Disorder Treatment among College Students Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Novel Intervention Promoting Eating Disorder Treatment Among College Students

Resource links provided by NLM:


Further study details as provided by Sarah Ketchen Lipson, University of Michigan:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Predictors of help-seeking behavior (e.g., perceived need/urgency, knowledge, attitudes, intentions to seek help) [ Time Frame: 12 weeks ]
    Predictors of help-seeking behavior (e.g., perceived need/urgency, knowledge, attitudes, intentions to seek help)


Enrollment: 1149
Study Start Date: January 2015
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Behavioral: Promoting Eating Disorder Treatment among College Students
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
Experimental: 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).
Behavioral: Promoting Eating Disorder Treatment among College Students
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
Experimental: 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).
Behavioral: Promoting Eating Disorder Treatment among College Students
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
Experimental: 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).
Behavioral: Promoting Eating Disorder Treatment among College Students
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
Experimental: 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).
Behavioral: Promoting Eating Disorder Treatment among College Students
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
Experimental: 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).
Behavioral: Promoting Eating Disorder Treatment among College Students
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
Experimental: 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).
Behavioral: Promoting Eating Disorder Treatment among College Students
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
Experimental: 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).
Behavioral: Promoting Eating Disorder Treatment among College Students
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02284685


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48104
United States, New York
Bard College
Annandale-on-Hudson, New York, United States, 12504
United States, North Carolina
Appalachian State University
Boone, North Carolina, United States, 28608
United States, Pennsylvania
Mercyhurst University
Erie, Pennsylvania, United States, 16546
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Sarah K Lipson, MEd University of Michigan
  More Information

Responsible Party: Sarah Ketchen Lipson, PhD Candidate, University of Michigan
ClinicalTrials.gov Identifier: NCT02284685     History of Changes
Other Study ID Numbers: F037058
1F31MH105149-01 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 2014
First Posted: November 6, 2014
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Sarah Ketchen Lipson, University of Michigan:
Mental Health Services

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders