NCT00627341

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 11, 2012

Status Verified

May 1, 2012

Enrollment Period

3 years

First QC Date

February 28, 2008

Last Update Submit

May 10, 2012

Conditions

Eating Disorders

Keywords

Exposure TherapyRelapse PreventionAnorexia Nervosa

Outcome Measures

Primary Outcomes (1)

  • Diet Energy Density and Variety score

    Measured before treatment and at Months 1, 2, 3, 4, 5, and 6

Secondary Outcomes (4)

  • Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score

    Measured before treatment and at Months 3 and 6

  • Body mass index (BMI)

    Measured weekly for 6 months

  • Amount consumed at test meals

    Measured two times before treatment and two times after Month 6

  • Reported levels of anxiety at test meals

    Measured two times before treatment and two times after Month 6

Study Arms (2)

Exposure and Response Prevention

EXPERIMENTAL

Participants will receive Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa for 6 months.

Behavioral: Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP)

Cognitive Behavior Therapy

ACTIVE COMPARATOR

Participants will receive cognitive behavioral therapy for anorexia nervosa for 6 months.

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP)BEHAVIORAL

AN-EX/RP will consist of in-session exposures to feared eating situations without using avoidance behaviors as well as formal motivational interviewing techniques.

Exposure and Response Prevention
Cognitive behavioral therapy (CBT)BEHAVIORAL

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.

Cognitive Behavior Therapy

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (2)

  • Steinglass JE, Albano AM, Simpson HB, Wang Y, Zou J, Attia E, Walsh BT. Confronting fear using exposure and response prevention for anorexia nervosa: A randomized controlled pilot study. Int J Eat Disord. 2014 Mar;47(2):174-80. doi: 10.1002/eat.22214. Epub 2013 Nov 8.

    PMID: 24488838DERIVED

  • Steinglass JE, Sysko R, Mayer L, Berner LA, Schebendach J, Wang Y, Chen H, Albano AM, Simpson HB, Walsh BT. Pre-meal anxiety and food intake in anorexia nervosa. Appetite. 2010 Oct;55(2):214-8. doi: 10.1016/j.appet.2010.05.090. Epub 2010 Jun 4.

    PMID: 20570701DERIVED

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia Nervosa

Interventions

Secondary PreventionCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public HealthBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joanna E. Steinglass, MD

    Research Foundation for Mental Hygiene, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 3, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 11, 2012

Record last verified: 2012-05

Locations

US(1)