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Completed

NCT Number: NCT01517906

Developing Identity: An Eating Disorder Randomized Clinical Trial

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.

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Key information

Conditions

Anorexia Nervosa Bulimia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: SPI

Primary outcomes

  1. Eating Disorder Interview

    Time frame: change from baseline to one month post-intervention

    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

  2. Eating Disorder Inventory

    Time frame: Change from baseline to one month 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

  3. Eating Disorder Interview

    Time frame: Change from baseline to 6 mos post-intervention

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

  4. Eating Disorder Interview

    Time frame: 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).

  5. Eating Disorder Inventory

    Time frame: Change from baseline to 6 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

  6. Eating Disorder Inventory

    Time frame: 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 outcomes

  1. Psychological Well-Being Scale

    Time frame: 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.

  2. SF-36 Survey

    Time frame: Baseline, immediate, 6 and 12 m post-intervention

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Developing Identity: An Eating Disorder Nursing Therapy

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Jan 25, 2012
Registry last updated
Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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