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Developing Identity: An Eating Disorder Randomized Clinical Trial

Developing Identity: An Eating Disorder Nursing Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01517906
Enrollment
69
Registered
2012-01-25
Start date
2002-04-30
Completion date
2006-12-31
Last updated
2012-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Bulimia Nervosa

Keywords

eating disorder behaviors, well being, functional health

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.

Interventions

BEHAVIORALIdentity 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.

BEHAVIORALSupportive 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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Eating Disorder Interviewchange from baseline to one month post-interventionA 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 InventoryChange from baseline to one month post-interventionA 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

MeasureTime frameDescription
Psychological Well-Being ScaleBaseline, immediate, 6, 12 m post-interventionThe 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 SurveyBaseline, immediate, 6 and 12 m post-intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026