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Testing an Internet-Based Intervention for Preventing Eating Disorders

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Image and Mood (IaM) program
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorders focused on measuring Bulimia Nervosa, Binge Eating, Binge-Eating Disorder

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Stanford University School of Medicine
  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Image and Mood (IaM) program

Wait-list control

Arm Description

Participants will participate in the IaM program.

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.

Outcomes

Primary Outcome Measures

Eating disorder diagnoses

Secondary Outcome Measures

Weight Concerns Scale
Eating Disorder Examination Questionnaires (EDE-Q)
Depressive symptoms, as measured by the Beck Depression Inventory and Center for Epidemiologic Studies-Depression Scale
Combined incidence of substance abuse, alcohol abuse, anxiety disorders, and depressive disorders

Full Information

First Posted
July 6, 2009
Last Updated
March 16, 2020
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH), Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00934583
Brief Title
Testing an Internet-Based Intervention for Preventing Eating Disorders
Official Title
Preventing Eating Disorders and Reducing Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH), Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Bulimia Nervosa, Binge Eating, Binge-Eating Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
549 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Image and Mood (IaM) program
Arm Type
Experimental
Arm Description
Participants will participate in the IaM program.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Image and Mood (IaM) program
Other Intervention Name(s)
Student Bodies+
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eating disorder diagnoses
Time Frame
Measured after 10 weeks, 1 year, and 1.5 years
Secondary Outcome Measure Information:
Title
Weight Concerns Scale
Time Frame
Measured after 10 weeks, 1 year, and 1.5 years
Title
Eating Disorder Examination Questionnaires (EDE-Q)
Time Frame
Measured after 10 weeks, 1 year, and 1.5 years
Title
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
Title
Combined incidence of substance abuse, alcohol abuse, anxiety disorders, and depressive disorders
Time Frame
Measured after 10 weeks, 1 year, and 1.5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Barr Taylor, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denise Wilfley, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5722
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16894064
Citation
Taylor CB, Bryson S, Luce KH, Cunning D, Doyle AC, Abascal LB, Rockwell R, Dev P, Winzelberg AJ, Wilfley DE. Prevention of eating disorders in at-risk college-age women. Arch Gen Psychiatry. 2006 Aug;63(8):881-8. doi: 10.1001/archpsyc.63.8.881.
Results Reference
background
PubMed Identifier
9589309
Citation
Taylor CB, Sharpe T, Shisslak C, Bryson S, Estes LS, Gray N, McKnight KM, Crago M, Kraemer HC, Killen JD. Factors associated with weight concerns in adolescent girls. Int J Eat Disord. 1998 Jul;24(1):31-42. doi: 10.1002/(sici)1098-108x(199807)24:13.0.co;2-1.
Results Reference
background
PubMed Identifier
12562570
Citation
McKnight Investigators. Risk factors for the onset of eating disorders in adolescent girls: results of the McKnight longitudinal risk factor study. Am J Psychiatry. 2003 Feb;160(2):248-54. doi: 10.1176/ajp.160.2.248. Erratum In: Am J Psychiatry. 2003 May;160(5):1024.
Results Reference
background
PubMed Identifier
12150647
Citation
Wilfley DE, Welch RR, Stein RI, Spurrell EB, Cohen LR, Saelens BE, Dounchis JZ, Frank MA, Wiseman CV, Matt GE. A randomized comparison of group cognitive-behavioral therapy and group interpersonal psychotherapy for the treatment of overweight individuals with binge-eating disorder. Arch Gen Psychiatry. 2002 Aug;59(8):713-21. doi: 10.1001/archpsyc.59.8.713.
Results Reference
background
PubMed Identifier
9550890
Citation
Wilfley DE, Cohen LR. Psychological treatment of bulimia nervosa and binge eating disorder. Psychopharmacol Bull. 1997;33(3):437-54.
Results Reference
background
PubMed Identifier
18377129
Citation
Manwaring JL, Bryson SW, Goldschmidt AB, Winzelberg AJ, Luce KH, Cunning D, Wilfley DE, Taylor CB. Do adherence variables predict outcome in an online program for the prevention of eating disorders? J Consult Clin Psychol. 2008 Apr;76(2):341-6. doi: 10.1037/0022-006X.76.2.341.
Results Reference
background
PubMed Identifier
17557971
Citation
Tanofsky-Kraff M, Wilfley DE, Young JF, Mufson L, Yanovski SZ, Glasofer DR, Salaita CG. Preventing excessive weight gain in adolescents: interpersonal psychotherapy for binge eating. Obesity (Silver Spring). 2007 Jun;15(6):1345-55. doi: 10.1038/oby.2007.162. Erratum In: Obesity (Silver Spring). 2007 Oct;15(10):2520.
Results Reference
background
PubMed Identifier
26795936
Citation
Taylor CB, Kass AE, Trockel M, Cunning D, Weisman H, Bailey J, Sinton M, Aspen V, Schecthman K, Jacobi C, Wilfley DE. Reducing eating disorder onset in a very high risk sample with significant comorbid depression: A randomized controlled trial. J Consult Clin Psychol. 2016 May;84(5):402-14. doi: 10.1037/ccp0000077. Epub 2016 Jan 21.
Results Reference
derived

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Testing an Internet-Based Intervention for Preventing Eating Disorders

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