NCT02284685

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,149

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

November 3, 2014

Last Update Submit

May 27, 2015

Conditions

Eating Disorders

Keywords

Mental Health Services

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (1)

  • Predictors of help-seeking behavior (e.g., perceived need/urgency, knowledge, attitudes, intentions to seek help)

    12 weeks

Study Arms (8)

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).

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).

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).

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).

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).

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).

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).

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).

Behavioral: Promoting Eating Disorder Treatment among College Students

Interventions

Promoting Eating Disorder Treatment among College StudentsBEHAVIORAL

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

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Less than 18 years of age
  • Studying abroad during study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

Bard College

Annandale-on-Hudson, New York, 12504, United States

Location

Appalachian State University

Boone, North Carolina, 28608, United States

Location

Mercyhurst University

Erie, Pennsylvania, 16546, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Sarah K Lipson, MEd

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 6, 2014

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(4)