Developing Identity: An Eating Disorder Randomized Clinical Trial
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About
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:
- Experimental counseling that focuses on building strengths and positive self-views
- 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.
Enrollment
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Inclusion criteria
- Anorexia nervosa
- Subthreshold anorexia nervosa
- Bulimia nervosa
- Subthreshold Bulimia nervosa
- Nonpregnant
- No prescribed psychotropic medication
- No concurrent psychiatric treatment
- No indications for inpatient treatment including suicide risk, significant metabolic or cardiac complications
- Willingness to refrain from seeking other forms of ED treatment until completing the intervention and post-treatment data collection protocols
- Negative lifetime history for schizophrenia, other DSM-IV Axis I psychotic disorders and mental retardation
Exclusion criteria
- Acute and chronic medical conditions other than those related to the ED
- Any other concurrent DSM-IV Axis I disorder at threshold level
Trial design
Primary purpose
Allocation
Interventional model
Masking
69 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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