Testing an Internet-Based Intervention for Preventing Eating Disorders

Eating Disorders Clinical Trial

Official title:

Preventing Eating Disorders and Reducing Comorbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934583
• Other study ID #: R01MH081124
• Secondary ID: R01MH081124
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: April 2012

Study information

• Verified date: March 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 549
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Eating Disorders
• Feeding and Eating Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Stanford University School of Medicine	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH), Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. Erratum in: Am J Psychiatry. 2003 May;160(5):1024. — View 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. Review. Erratum in: Obesity (Silver Spring). 2007 Oct;15(10):2520. — View 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. — View 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. — View Citation

Wilfley DE, Cohen LR. Psychological treatment of bulimia nervosa and binge eating disorder. Psychopharmacol Bull. 1997;33(3):437-54. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating disorder diagnoses		Measured after 10 weeks, 1 year, and 1.5 years
Secondary	Weight Concerns Scale		Measured after 10 weeks, 1 year, and 1.5 years
Secondary	Eating Disorder Examination Questionnaires (EDE-Q)		Measured after 10 weeks, 1 year, and 1.5 years
Secondary	Depressive symptoms, as measured by the Beck Depression Inventory and Center for Epidemiologic Studies-Depression Scale		Measured after 10 weeks, 1 year, and 1.5 years
Secondary	Combined incidence of substance abuse, alcohol abuse, anxiety disorders, and depressive disorders		Measured after 10 weeks, 1 year, and 1.5 years