Clinical trial NCT00934583: Testing an Internet-Based Intervention for Preventing Eating Disorders
Official title: Preventing Eating Disorders and Reducing Comorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Keywords: Bulimia Nervosa
Binge Eating
Binge-Eating Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Washington University School of Medicine
First posted: 2009-07-08
Enrollment: 549
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Eating disorder diagnoses
timeFrame: Measured after 10 weeks, 1 year, and 1.5 years
Secondary outcomes:
measure: Weight Concerns Scale
timeFrame: Measured after 10 weeks, 1 year, and 1.5 years
measure: Eating Disorder Examination Questionnaires (EDE-Q)
timeFrame: Measured after 10 weeks, 1 year, and 1.5 years
measure: Depressive symptoms, as measured by the Beck Depression Inventory and Center for Epidemiologic Studies-Depression Scale
timeFrame: Measured after 10 weeks, 1 year, and 1.5 years
measure: Combined incidence of substance abuse, alcohol abuse, anxiety disorders, and depressive disorders
timeFrame: Measured after 10 weeks, 1 year, and 1.5 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Stanford University
name: C. Barr Taylor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Denise Wilfley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: Wilfley DE, Cohen LR. Psychological treatment of bulimia nervosa and binge eating disorder. Psychopharmacol Bull. 1997;33(3):437-54.
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.
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.
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.