Testing an Internet-Based Intervention for Preventing Eating Disorders

This study has been completed.
Sponsor:
Collaborators:
Washington University School of Medicine
Information provided by (Responsible Party):
Craig Barr Taylor, Stanford University
ClinicalTrials.gov Identifier:
NCT00934583
First received: July 6, 2009
Last updated: June 5, 2012
Last verified: May 2012
  Purpose

This study will examine the ability of an Internet-based program to prevent college-aged women from developing eating disorders.


Condition Intervention
Eating Disorders
Behavioral: Image and Mood (IaM) program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Eating Disorders and Reducing Comorbidity

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Eating disorder diagnoses [ Time Frame: Measured after 10 weeks, 1 year, and 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight Concerns Scale [ Time Frame: Measured after 10 weeks, 1 year, and 1.5 years ] [ Designated as safety issue: No ]
  • Eating Disorder Examination Questionnaires (EDE-Q) [ Time Frame: Measured after 10 weeks, 1 year, and 1.5 years ] [ Designated as safety issue: No ]
  • Depressive symptoms, as measured by the Beck Depression Inventory and Center for Epidemiologic Studies-Depression Scale [ Time Frame: Measured after 10 weeks, 1 year, and 1.5 years ] [ Designated as safety issue: No ]
  • Combined incidence of substance abuse, alcohol abuse, anxiety disorders, and depressive disorders [ Time Frame: Measured after 10 weeks, 1 year, and 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 549
Study Start Date: August 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Image and Mood (IaM) program
Participants will participate in the IaM program.
Behavioral: Image and Mood (IaM) program
A 10-week Internet-based intervention focused on (1) identifying and challenging automatic thoughts in order to improve body image and reduce negative affect, (2) developing adaptive emotion and behavior regulation skills associated with preventing disordered eating and negative affect, and (3) teaching relapse prevention skills. The program includes an online discussion group moderated by a study clinician.
Other Name: Student Bodies+
No Intervention: Wait-list control
Participants will be placed on a wait list until after participants in the IaM group have completed all assessments. After that, these participants will be offered the option to complete the IaM program.

Detailed Description:

Approximately 2% to 4% of college-aged women suffer from eating disorders (EDs), and many more are at risk of developing them. A previous Internet-based intervention called Student Bodies (SB), which focused on body image concerns, was effective in reducing risk factors for EDs among college-aged women. However, the original SB program did not account for certain other risk factors, such as depression and compensatory behaviors like self-induced vomiting, over-exercising, or use of diuretics. Image and Mood (IaM) is an enhanced version of the SB program and takes into account depressive symptoms and the use of compensatory behaviors. This study will examine whether IaM will reduce ED risk factors in a large population of college women who are at high risk of developing EDs.

Participation in this study will last 10 weeks. Participants will be randomly assigned to either receive the IaM program or be placed on a wait list. The IaM program, which will be delivered through the Internet, will provide information about nutrition, exercise, body image, and coping skills—including examples and exercises. It will also include an online message board monitored by a study psychologist. Each week the IaM participants will monitor their behavior, keep a journal about their experiences, and answer self-report questionnaires. Assessments of eating disorder symptoms; weight and shape concerns; depressive symptoms; and incidence of substance abuse, anxiety, or depressive disorders will be completed post-treatment and at 1- and 1.5-month follow-ups. Those assigned to the wait list will complete these assessments and then receive the IaM program after the last follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Primary Aim:

  • Access to a computer with an Internet connection
  • Weight Concerns Scale score greater than or equal to 47
  • Presence of one additional risk factor, including a history of teasing, a history of depression, or low levels of compensatory behaviors (defined as less than four times per month)

Inclusion Criteria for Secondary Aim:

  • Access to a computer with an Internet connection
  • Weight Concerns Scale score greater than or equal to 47

Exclusion Criteria for Both Primary and Secondary Aims:

  • Current diagnosis of an eating disorder
  • Treated for an eating disorder within the past 6 months
  • Currently receiving psychological treatment for an eating disorder or depressive disorder
  • Started a new psychiatric medication within the past 2 months
  • Exhibiting a level of psychopathology that would interfere with participation (e.g., acutely suicidal)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934583

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305-5722
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Stanford University
Washington University School of Medicine
Investigators
Principal Investigator: C. Barr Taylor, MD Stanford University
Principal Investigator: Denise Wilfley, PhD Washington University School of Medicine
  More Information

Publications:

Responsible Party: Craig Barr Taylor, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00934583     History of Changes
Other Study ID Numbers: R01 MH081124, R01MH081124, R01 MH081124, DSIR 84-CTP
Study First Received: July 6, 2009
Last Updated: June 5, 2012
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Bulimia Nervosa
Binge Eating
Binge-Eating Disorder

Additional relevant MeSH terms:
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014