Clinical trial NCT01517906: Developing Identity: An Eating Disorder Randomized Clinical Trial
Official title: Developing Identity: An Eating Disorder Nursing Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Bulimia Nervosa
Keywords: eating disorder behaviors
well being
functional health
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Eating Disorder Interview
timeFrame: change from baseline to one month post-intervention
measure: Eating Disorder Inventory
timeFrame: Change from baseline to one month post-intervention
measure: Eating Disorder Interview
timeFrame: Change from baseline to 6 mos post-intervention
measure: Eating Disorder Interview
timeFrame: Change from baseline to 12 months post-intervention
measure: Eating Disorder Inventory
timeFrame: Change from baseline to 6 mos post-intervention
measure: Eating Disorder Inventory
timeFrame: Change from baseline to 12 mos post-intervention
Secondary outcomes:
measure: Psychological Well-Being Scale
timeFrame: Baseline, immediate, 6, 12 m post-intervention
measure: SF-36 Survey
timeFrame: Baseline, immediate, 6 and 12 m post-intervention
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
Study officials:
affiliation: University of Rochester
name: Karen F Stein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stein KF, Wing J, Lewis A, Raghunathan T. An eating disorder randomized clinical trial and attrition: profiles and determinants of dropout. Int J Eat Disord. 2011 May;44(4):356-68. doi: 10.1002/eat.20800.
citation: Stein KF, Corte C, Chen DG, Nuliyalu U, Wing J. A randomized clinical trial of an identity intervention programme for women with eating disorders. Eur Eat Disord Rev. 2013 Mar;21(2):130-42. doi: 10.1002/erv.2195. Epub 2012 Sep 27.