- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02284685
A Novel Intervention Promoting Eating Disorder Treatment Among College Students
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Michigan
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Ann Arbor, Michigan, Forenede Stater, 48104
- University of Michigan
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-
New York
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Annandale-on-Hudson, New York, Forenede Stater, 12504
- Bard College
-
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North Carolina
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Boone, North Carolina, Forenede Stater, 28608
- Appalachian State University
-
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Pennsylvania
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Erie, Pennsylvania, Forenede Stater, 16546
- Mercyhurst University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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).
|
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
|
|
Eksperimentel: 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).
|
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
|
|
Eksperimentel: 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).
|
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
|
|
Eksperimentel: 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).
|
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
|
|
Eksperimentel: 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).
|
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
|
|
Eksperimentel: 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).
|
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
|
|
Eksperimentel: 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).
|
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
|
|
Eksperimentel: 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).
|
Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Help-seeking behavior (Use of services (e.g., counseling/therapy) for eating and body image issues)
Tidsramme: 12 weeks
|
Use of services (e.g., counseling/therapy) for eating and body image issues
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Predictors of help-seeking behavior (e.g., perceived need/urgency, knowledge, attitudes, intentions to seek help)
Tidsramme: 12 weeks
|
Predictors of help-seeking behavior (e.g., perceived need/urgency, knowledge, attitudes, intentions to seek help)
|
12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sarah K Lipson, MEd, University of Michigan
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- F037058
- 1F31MH105149-01 (U.S. NIH-bevilling/kontrakt)
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