Developing Identity: An Eating Disorder Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Anorexia Nervosa; Bulimia Nervosa
• Interventions: Behavioral: Identity Intervention Program; Behavioral: Supportive Psychotherapy for the Eating Disorders

• Registration Number: NCT01517906
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-20
• Last Update Submitted: 2012-01-20
• Study First Posted: 2012-01-25
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral counseling	Identity Intervention Program	-
Supportive therapy	Supportive Psychotherapy for the Eating Disorders	-

Primary Outcome Measures

Name	Time	Method
Eating Disorder Interview	Change from baseline to 12 months post-intervention	A computerized menu-driven interview will be used to prospectively measure ED behaviors (event-triggered EMA methodology).
Eating Disorder Inventory	Change from baseline to 12 mos post-intervention	A self-report measure of the ED attitudes associated with AN and BN that is widely used as an outcome measure in intervention studies. The inventory consists of 64 items that are used to generate eight subscale scores. In this study, the drive for thinness, body dissatisfaction and bulimia subscale scores will be used

Secondary Outcome Measures

Name	Time	Method
Psychological Well-Being Scale	Baseline, immediate, 6, 12 m post-intervention	The questionnaire measures 6 theoretically derived dimensions of psychological well-being including: Self-Acceptance, Positive Relations with Others, Autonomy, Environmental Mastery, Purpose in Life and Personal Growth. Each dimension is measured with a 14-item subscale.
SF-36 Survey	Baseline, immediate, 6 and 12 m post-intervention

Trial Locations

Locations (1)

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States