Expired Study
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New York, New York 10032


Purpose:

This study will compare the effectiveness of two types of psychotherapy, a relapse prevention program and cognitive behavioral therapy, in reducing relapse and fear of eating situations in people with anorexia nervosa.


Study summary:

Anorexia nervosa (AN) is a serious and often chronic eating disorder characterized by restrictive eating habits and failure to maintain a healthy minimal body weight. Symptoms of AN may include distorted body image, fear of weight gain, obsessive exercise, and binge and purge eating behaviors. In severe cases of AN, a person may practice extreme dieting to levels of near starvation. These unhealthy behaviors may cause further medical complications, including organ damage, irregular heart rhythm, premature osteoporosis, and heart failure. AN has one of the highest mortality rates of all psychiatric disorders, claiming the lives of up to 6% of those affected. When treated with a form of psychotherapy and nutritional guidance, people can restore weight to healthy levels and recover from AN, but the chance of relapse remains high. A program aimed specifically at reducing relapse, Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP), may be more effective than common psychotherapy treatments, such as cognitive behavioral therapy (CBT), in enhancing long-term recovery from AN. This study will compare the effectiveness of AN-EX/RP with CBT in reducing relapse and fear of eating situations in people with AN. Participants in this study will include patients who have achieved normal weight while inpatients at the New York State Psychiatric Unit. Eligible participants will undergo initial assessments that will include questionnaires, interviews, and two laboratory-based meals. Participants will then be assigned randomly to receive 6 months of outpatient psychotherapy treatment with either AN-EX/RP or CBT. Participants assigned to receive AN-EX/RP will attend 90-minute sessions twice weekly for the first few months, then weekly thereafter. Sessions will focus on fear of eating situations and will help participants to confront, rather than avoid, these fears in order to learn through practice that the fears are unrealistic. Participants assigned to receive CBT will attend treatment sessions twice weekly for the first month and then weekly thereafter. CBT sessions will focus on thoughts, feelings, and behaviors that perpetuate the eating disorder, with the aim to develop healthier patterns. After completing the 6 months of treatment, all participants will repeat the initial assessments.


Criteria:

Inclusion Criteria: - Meets DSM-IV-TR criteria for anorexia nervosa (restricting or binge-purge subtype), with or without amenorrhea after inpatient admission - Has achieved 90% of ideal body weight or BMI greater than or equal to 19.5 kg/m2 for at least 1 week after inpatient admission - Medically stable Exclusion Criteria: - Chronic psychotic or bipolar I disorder requiring ongoing treatment with antipsychotic or mood stabilizer - Diagnosis of obsessive compulsive disorder in which the symptoms are clearly unrelated to eating disorders - Current substance abuse - Current use of psychotropic medication - Acute suicidality (suicidality or self-injury in the 3 months before study entry) - Serious medical illness


Study is Available At:


Original ID:

#5593


NCT ID:

NCT00627341


Secondary ID:

R01MH082736


Study Acronym:


Brief Title:

A Relapse Prevention Program for Reducing Relapse and Fear of Food in People With Anorexia Nervosa


Official Title:

Addressing Fear of Food in Anorexia Nervosa


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

16 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York State Psychiatric Institute


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

34


Enrollment Type:

Actual


Overall Contact Information

Official Name:Joanna E. Steinglass, MD
Principal Investigator
Research Foundation for Mental Hygiene, Inc.

Study Dates

Start Date:December 2007
Completion Date:December 2010
Completion Type:Actual
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:May 2012
Last Changed Date:May 10, 2012
First Received Date:February 28, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Reported levels of anxiety at test meals
Time Frame:Measured two times before treatment and two times after Month 6
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Amount consumed at test meals
Time Frame:Measured two times before treatment and two times after Month 6
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Body mass index (BMI)
Time Frame:Measured weekly for 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score
Time Frame:Measured before treatment and at Months 3 and 6
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Diet Energy Density and Variety score
Time Frame:Measured before treatment and at Months 1, 2, 3, 4, 5, and 6
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Food Exposure Therapy and Ritual Prevention with M
Description:AN-EX/RP will consist of in-session exposures to feared eating situations without using avoidance behaviors as well as formal motivational interviewing techniques.
Arm Name:Exposure and Response Prevention
Intervention Type:Behavioral
Name:Cognitive behavioral therapy (CBT)
Description:CBT for anorexia nervosa sessions will focus on behaviorally normalizing eating patterns throughout the day and on cognitively addressing dysfunctional thinking that promotes disordered eating.
Arm Name:Cognitive Behavior Therapy

Study Arms

Study Arm Type:Experimental
Arm Name:Exposure and Response Prevention
Description:Participants will receive Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa for 6 months.
Study Arm Type:Active Comparator
Arm Name:Cognitive Behavior Therapy
Description:Participants will receive cognitive behavioral therapy for anorexia nervosa for 6 months.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York State Psychiatric Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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