Developing Identity: An Eating Disorder Randomized Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Farchaus Stein, University of Michigan
ClinicalTrials.gov Identifier:
NCT01517906
First received: January 18, 2012
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Anorexia Nervosa
Bulimia Nervosa
Behavioral: Identity Intervention Program
Behavioral: Supportive Psychotherapy for the Eating Disorders

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing Identity: An Eating Disorder Nursing Therapy

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Eating Disorder Interview [ Time Frame: change from baseline to one month post-intervention ] [ Designated as safety issue: No ]
    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

  • Eating Disorder Inventory [ Time Frame: Change from baseline to one month post-intervention ] [ Designated as safety issue: No ]
    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

  • Eating Disorder Interview [ Time Frame: Change from baseline to 6 mos post-intervention ] [ Designated as safety issue: No ]
    A computerized menu-driven interview will be used to prospectively measure ED behaviors (event-triggered EMA methodology). Behaviors measured same as above

  • Eating Disorder Interview [ Time Frame: Change from baseline to 12 months post-intervention ] [ Designated as safety issue: No ]
    A computerized menu-driven interview will be used to prospectively measure ED behaviors (event-triggered EMA methodology).

  • Eating Disorder Inventory [ Time Frame: Change from baseline to 6 mos post-intervention ] [ Designated as safety issue: No ]
    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

  • Eating Disorder Inventory [ Time Frame: Change from baseline to 12 mos post-intervention ] [ Designated as safety issue: No ]
    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:
  • Psychological Well-Being Scale [ Time Frame: Baseline, immediate, 6, 12 m post-intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, immediate, 6 and 12 m post-intervention ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: April 2002
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive behavioral counseling Behavioral: Identity Intervention Program
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.
Active Comparator: Supportive therapy Behavioral: Supportive Psychotherapy for the Eating Disorders
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.
Other Name: SPI

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517906

Locations
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Karen F Stein, PhD University of Rochester
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Farchaus Stein, Professor of Nursing, University of Michigan
ClinicalTrials.gov Identifier: NCT01517906     History of Changes
Other Study ID Numbers: R01 NR05277
Study First Received: January 18, 2012
Last Updated: January 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
eating disorder behaviors
well being
functional health

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Bulimia
Eating Disorders
Bulimia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Hyperphagia

ClinicalTrials.gov processed this record on April 17, 2014