Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT01517906
Status:
COMPLETED
Last Update Posted:
2012-01-25
First Post:
2012-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Identity: An Eating Disorder Randomized Clinical Trial
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Developing Identity: An Eating Disorder Nursing Therapy
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to test a new type of counseling developed to decrease symptoms of anorexia nervosa and bulimia nervosa and improve health and well-being in women with these eating disorders. At this time, the most effective form of treatment for anorexia nervosa and bulimia nervosa is cognitive behavioral therapy. However, this form of treatment leads to a complete absence of symptoms in only about 50% of persons completing the treatment program. In this study we will test the effectiveness of a new form of counseling that focuses on identifying and building personal strengths and positive views of the self as the means to decrease eating disorder symptoms and improve health. This study will involve 150 women between the ages of 18 and 35 years who currently have symptoms of anorexia nervosa or bulimia nervosa. To participate in this study, women must also be: 1) not pregnant, 2) without any other diagnosable mental disorder, 3) not currently taking medications for their eating disorder or other mental disorder symptoms, 4) not ill enough to require inpatient treatment for their eating disorder and 5) willing to refrain from seeking other treatment for their eating disorder for the duration of this study. Each participant will participate in a 20-week treatment program that includes nutritional counseling and medical care. Both of these forms of treatment are considered by the American Psychiatric Association to be essential parts of treatment for eating disorders and have been found help to reduce symptoms. In addition, participants will receive one of two types of counseling:
1. Experimental counseling that focuses on building strengths and positive self-views
2. Standard counseling that helps the participant identify and solve problems that are believed to contribute to their eating disorder symptoms.
The type of counseling that a participant receives will be determined randomly. To determine whether the experimental counseling is effective, eating disorder symptoms, psychological and functional health will be measured before the treatment begins and three times after the treatment ends (immediately after treatment ends, 6 and 12 months later). The findings of this research study are expected to contribute to the development of effective interventions to decrease eating disorder symptoms, and increase health and well-being in women with anorexia nervosa and bulimia nervosa.
1. Experimental counseling that focuses on building strengths and positive self-views
2. Standard counseling that helps the participant identify and solve problems that are believed to contribute to their eating disorder symptoms.
The type of counseling that a participant receives will be determined randomly. To determine whether the experimental counseling is effective, eating disorder symptoms, psychological and functional health will be measured before the treatment begins and three times after the treatment ends (immediately after treatment ends, 6 and 12 months later). The findings of this research study are expected to contribute to the development of effective interventions to decrease eating disorder symptoms, and increase health and well-being in women with anorexia nervosa and bulimia nervosa.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: