Developing Identity: An Eating Disorder Randomized Clinical Trial

NCT01517906 | Completed

• 1 other identifier: R01NR005277
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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. 1.Experimental counseling that focuses on building strengths and positive self-views
2. 2.Standard counseling that helps the participant identify and solve problems that are believed to contribute to their eating disorder symptoms.

Conditions

Anorexia Nervosa; Bulimia Nervosa

Keywords

eating disorder behaviors; well being; functional health

Outcome Measures

Primary Outcomes (6)

• Eating Disorder Interview

  A computerized menu-driven interview will be used to prospectively measure ED behaviors (event-triggered EMA methodology). Behaviors measured as outcomes include binge eating, purging, fasting \& restricting and excessive exercise

  change from baseline to one month post-intervention

• Eating Disorder Inventory

  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

  Change from baseline to one month post-intervention

• Eating Disorder Interview

  A computerized menu-driven interview will be used to prospectively measure ED behaviors (event-triggered EMA methodology). Behaviors measured same as above

  Change from baseline to 6 mos post-intervention

• Eating Disorder Interview

  A computerized menu-driven interview will be used to prospectively measure ED behaviors (event-triggered EMA methodology).

  Change from baseline to 12 months post-intervention

• Eating Disorder Inventory

  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

  Change from baseline to 6 mos post-intervention

• Eating Disorder Inventory

  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

  Change from baseline to 12 mos post-intervention

Secondary Outcomes (2)

• Psychological Well-Being Scale

  Baseline, immediate, 6, 12 m post-intervention

• SF-36 Survey

  Baseline, immediate, 6 and 12 m post-intervention

Study Arms (2)

Cognitive behavioral counseling

EXPERIMENTAL

Behavioral: Identity Intervention Program

Supportive therapy

ACTIVE COMPARATOR

Behavioral: Supportive Psychotherapy for the Eating Disorders

Interventions

Identity Intervention Program BEHAVIORAL

Cognitive behavioral strategies will be used by trained nurse-therapists to facilitate the participant's: a) identification of a small collection of personally meaningful and feasible desired possible selves, b) prioritization of the desired possible selves as short and long-term goals, c) identification, elaboration, implementation and evaluation of cognitive and behavioral strategies to achieve the desired possible self selected as the goal, and d) identification of internal and external barriers that interfere with achieving the possible self goal and utilization of active problem solving strategies to overcome the barriers.

Cognitive behavioral counseling

Supportive Psychotherapy for the Eating Disorders BEHAVIORAL

SPI is a 20-week program with a one-hour individual psychotherapy session scheduled each week. The SPI is organized in three stages: 1) Stage 1 (Sessions 1-8) including assessment of the current and past ED history, collection of personal and family history, and identification of problems contributing to the ED; 2) Stage 2 (Sessions 9-16) aims include exploration of underlying emotional problems, increased self-disclosure and expression of feelings, and fostering independence; and 3) Stage 3 (Sessions 17-20) includes continued exploration of underlying problems and implications for future behaviors and termination.

Also known as: SPI

Supportive therapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Acute and chronic medical conditions other than those related to the ED
• Any other concurrent DSM-IV Axis I disorder at threshold level

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• 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.

  PMID: 21472754 RESULT

• 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.

  PMID: 23015537 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Bulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Karen F Stein, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 25, 2012
• Study Start: April 1, 2002
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

US (1)