NCT02076464

Brief Summary

The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce eating disorder outcomes in college-age women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
690

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 12, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

4.9 years

First QC Date

February 26, 2014

Last Update Submit

November 5, 2019

Conditions

Eating Disorders

Outcome Measures

Primary Outcomes (1)

  • Change in eating disorder symptoms

    Eating disorder outcomes will be measured using the Eating Disorder Examination Questionnaire

    Measured at baseline, 6-months, 1-year, and 2-years

Secondary Outcomes (4)

  • Realized treatment access

    2 years

  • Eating disorder behavior abstinence rates

    2 years

  • Comorbid symptom severity and impairment

    2 years

  • Service and implementation costs

    up to 5 years

Study Arms (2)

StudentBodies - Eating Disorders

EXPERIMENTAL

Participants will participate in the StudentBodies - Eating Disorders program

Behavioral: StudentBodies - Eating Disorders

Usual Care

NO INTERVENTION

Participants will be referred to treatment per protocol at students' corresponding college's mental health services center

Interventions

StudentBodies - Eating DisordersBEHAVIORAL

The intervention is a structured, cognitive-behavioral guided self-help program, derived from manual-based cognitive-behavioral therapy. The intervention targets the core eating disorder pathology (e.g., extreme dietary restraint, overvaluation of shape and weight, binge eating, compensatory behaviors), focusing on helping users develop regular eating patterns, self-control strategies, problem-solving skills, and relapse prevention tools for maintenance of behavior change. The program includes daily symptom checklists, journal exercises and activities, and an asynchronous moderated online discussion group.

StudentBodies - Eating Disorders

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Student at a participating college or university ages 18-30
  • Screen positive for DSM-5 bulimia nervosa, binge eating disorder, or a subclinical eating disorder

You may not qualify if:

  • Screen positive for DSM-5 anorexia nervosa
  • No access to the internet
  • Acutely suicidal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Graham AK, Fitzsimmons-Craft EE, Sadeh-Sharvit S, Balantekin KN, Eichen DM, Firebaugh ML, Goel NJ, Monterubio GE, Karam AM, Flatt RE, Jo B, Jacobi C, Wilfley DE, Taylor CB, Trockel M. Moderators and mediators of a digital cognitive behavior therapy-guided self-help intervention for eating disorders: Informing future design efforts. J Consult Clin Psychol. 2023 May;91(5):280-284. doi: 10.1037/ccp0000786. Epub 2023 Jan 12.

    PMID: 36634022DERIVED

  • Fitzsimmons-Craft EE, Taylor CB, Graham AK, Sadeh-Sharvit S, Balantekin KN, Eichen DM, Monterubio GE, Goel NJ, Flatt RE, Karam AM, Firebaugh ML, Jacobi C, Jo B, Trockel MT, Wilfley DE. Effectiveness of a Digital Cognitive Behavior Therapy-Guided Self-Help Intervention for Eating Disorders in College Women: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2015633. doi: 10.1001/jamanetworkopen.2020.15633.

    PMID: 32865576DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Denise E. Wilfley, Ph.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • C. Barr Taylor, M.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 3, 2014

Study Start

January 12, 2014

Primary Completion

November 27, 2018

Study Completion

November 27, 2018

Last Updated

November 6, 2019

Record last verified: 2019-11