Anorexia NervosaNCT01517906
Developing Identity: An Eating Disorder Randomized Clinical Trial
A study testing Identity Intervention Program and Supportive Psychotherapy for the Eating Disorders in people with Anorexia Nervosa and Bulimia Nervosa, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- Identity Intervention Program and Supportive Psychotherapy for the Eating Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Anorexia nervosa
- Subthreshold anorexia nervosa
- Bulimia nervosa
- Subthreshold Bulimia nervosa
- Nonpregnant
- No prescribed psychotropic medication
Show all 10Show fewer
- 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
Who cannot join
- Acute and chronic medical conditions other than those related to the ED
- Any other concurrent DSM-IV Axis I disorder at threshold level
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
About this study
Official title: Developing Identity: An Eating Disorder Nursing Therapy
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:
- Experimental counseling that focuses on building strengths and positive self-views
- 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.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Being tested
- Identity Intervention Program, Supportive Psychotherapy for the Eating Disorders
- Keywords
- eating disorder behaviors, well being, functional health
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identity Intervention ProgramBehavioural
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 DisordersBehavioural
Also called SPI
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral counseling | Experimental | Not described Receives: Behavioral: Identity Intervention Program |
| Supportive therapy | Active comparator | Not described Receives: Behavioral: Supportive Psychotherapy for the Eating Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
Measured: Change from baseline to 12 mos post-intervention
Secondary outcomes (2)
Psychological Well-Being Scale
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.
Measured: Baseline, immediate, 6, 12 m post-intervention
SF-36 Survey
Measured: Baseline, immediate, 6 and 12 m post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startApr 2002
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Farchaus Stein, University of Michigan
- Investigators
- Karen F Stein, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517906
- Sponsor's protocol ID
- R01NR005277
- Status last verified
- Jan 2012
- First submitted
- 18 Jan 2012
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21472754Stein 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.
PubMed 23015537
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Identity: An Eating Disorder Nursing Therapy
- ClinicalTrials.gov ID
- NCT01517906
- Acronym / sponsor ID
- R01NR005277
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Keywords
- eating disorder behaviors, well being, functional health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Experimental counseling that focuses on building strengths and positive self-views
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral counseling | Experimental | Behavioral: Identity Intervention Program |
| Supportive therapy | Active comparator | Behavioral: Supportive Psychotherapy for the Eating Disorders |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Anorexia nervosa
- Subthreshold anorexia nervosa
- Bulimia nervosa
- Subthreshold Bulimia nervosa
- Nonpregnant
Key exclusion criteria (2 listed)
- Acute and chronic medical conditions other than those related to the ED
- Any other concurrent DSM-IV Axis I disorder at threshold level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identity Intervention ProgramCognitive 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. | Behavioural | Cognitive behavioral counseling |
| Supportive Psychotherapy for the Eating DisordersAlso: SPISPI 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. | Behavioural | Supportive therapy |
Primary outcome
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
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
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
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).
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
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
2 secondary outcomes
Psychological Well-Being Scale
Time frame: Baseline, immediate, 6, 12 m post-intervention
SF-36 Survey
Time frame: Baseline, immediate, 6 and 12 m post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
- Results publication: PubMed 21472754Stein 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.
- Derived from this study: PubMed 23015537Stein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen F Stein, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identity Intervention Program and Supportive Psychotherapy for the Eating Disorders in people with Anorexia Nervosa and Bulimia Nervosa, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Interview (time frame: change from baseline to one month post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01517906, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2012; AzTrials last refreshed its copy on 28 Oct 2026.