NCT00815815

Brief Summary

This study will examine the effectiveness of inpatient treatment for anorexia nervosa versus a sequenced treatment that transitions from higher intensity inpatient care to lower intensity outpatient care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2008

Completed
Last Updated

September 21, 2023

Status Verified

August 1, 2013

Enrollment Period

4 years

First QC Date

December 29, 2008

Last Update Submit

September 19, 2023

Conditions

Eating Disorders

Keywords

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

  • Weight

    Measured over 18 months

Secondary Outcomes (3)

  • Eating behaviors

    Measured over 18 months

  • Psychopathology associated with eating behaviors

    Measured over 18 months

  • Utilization of health care services

    Measured over 18 months

Study Arms (2)

Continued inpatient treatment

ACTIVE COMPARATOR

Participants will undergo inpatient hospital treatment until they have gained enough weight to be discharged.

Behavioral: Structured Behavioral Treatment

Sequenced treatment

EXPERIMENTAL

Participants will begin with inpatient treatment, transition to day patient treatment, and then transition to outpatient treatment.

Behavioral: Structured Behavioral Treatment

Interventions

Structured Behavioral TreatmentBEHAVIORAL

Daily therapy sessions and a weight gain protocol involving set meals and exercise levels

Continued inpatient treatmentSequenced treatment

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of anorexia nervosa, according to DSM-IV criteria
  • Body mass index (BMI) less than 18.5 kg/m2

You may not qualify if:

  • Presence of psychosis or the axis I disorders of schizophrenia, bipolar disorder, or active substance abuse or dependence requiring specialized treatment
  • Requires specialized treatment that is for major depression or anxiety disorders and is inconsistent with study treatments
  • Any major medical illness requiring immediate medical treatment or that would affect clinical treatment associated with the study
  • Significant risk of suicide

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

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia Nervosa

Condition Hierarchy (Ancestors)

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

Study Officials

  • Evelyn Attia, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2008

First Posted

December 31, 2008

Study Start

February 1, 2004

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

September 21, 2023

Record last verified: 2013-08

Locations

US(1)