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CompletedNCT00815815Updated Sep 21, 2023

Effectiveness of High Intensity Inpatient Versus Stepped Intensity Treatment for Anorexia Nervosa

An interventional study of Structured Behavioral Treatment in Eating Disorders, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
16 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

Anorexia nervosa is an eating disorder in which a person does not eat enough to maintain a healthy body weight. This disorder can lead to starvation, which may, in turn, lead to heart failure or brain damage. Anorexia can also lead to a host of other health problems, including mild anemia, swollen joints, and brittle bones. Treatment for anorexia begins by attempting to bring the anorexic person to a healthy body weight, while also conducting therapy aimed at developing habits and ways of thinking that promote maintenance of a healthy weight. Traditionally, the first part of this treatment-restoring healthy body weight-has taken place in inpatient hospital care. Recently, however, some patients have begun with high intensity inpatient care and then shifted to lower intensity outpatient care over the course of treatment. This study will compare the effectiveness of these two different methods of delivering treatment.

Length of participation in this study will vary, depending on the effectiveness of treatment. All participants will have follow-up assessments for 18 months after study entry. Every participant who passes the screening examination will be admitted to inpatient care in the study hospital. On Day 3 of their stay, participants will be randomly assigned to receive either continued inpatient treatment or sequenced treatment.

Those who receive continued inpatient treatment will stay in the hospital until they reach a healthy body weight and maintain it for 10 to 14 days. The average length of inpatient treatment will be 2 to 3 months. Those who receive sequenced treatment will transition to day patient status once they have met the following health benchmarks: an increase in body mass index (BMI) greater than 15.5 kg/m2; normal electrocardiograms, lab test results, and vital signs; eating all meals for more than 3 days; no weight loss for at least 1 week or weight gain for at least 1 week if the weight gain protocol has begun; and moderate improvement on a clinical global impression (CGI) rating of eating disorder behavior. If participants do not meet these benchmarks and are not at medical risk or suicidal, they will be automatically transitioned to day patient care after 28 days. Once participants reach the day patient status, they will be in the hospital Monday through Friday from 8:00 a.m. until 6:00 p.m. If these participants then reach and maintain a healthy body weight for 10 to 14 days, they will be transitioned to outpatient care, during which they will receive 50-minute therapy sessions once or twice weekly.

The aims and methods of treating anorexia will be the same for both groups. All participants will be prescribed meals, a snack, and dietary supplements in order to reach a healthy weight. The amount of exercise they engage in will be limited to ensure weight gain. Participants will also attend individual, family, and group therapy sessions aimed at supporting healthy thoughts and beliefs about eating behavior. Measurements of weight gain will be made every Monday, Wednesday, and Friday morning. Every 3 months participants will undergo blood tests and assessments of eating behaviors, associated psychopathology, and health service utilization. Clinical interviews will be conducted twice: once at study entry and once after 18 months.

02

Conditions studied

  • Eating Disorders

Keywords

  • Anorexia Nervosa
03

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 41 is close to the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Active comparator
    Continued inpatient treatment

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

    Behavioral: Structured Behavioral Treatment

  • Experimental
    Sequenced treatment

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

    Behavioral: Structured Behavioral Treatment

Interventions

  • BehavioralStructured Behavioral Treatment

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

06

What researchers measure

Primary outcomes

  1. Weight

    Time frame: Measured over 18 months

Secondary outcomes

  1. Eating behaviors

    Time frame: Measured over 18 months

  2. Psychopathology associated with eating behaviors

    Time frame: Measured over 18 months

  3. Utilization of health care services

    Time frame: Measured over 18 months

07

Study locations

1 site
  • New York State Psychiatric Institute
    New York, New York 10032, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00815815
Lead sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Dec 31, 2008
Start date
Feb 2004
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Sep 21, 2023

Study contacts

Evelyn Attia, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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