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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00815815
First received: December 29, 2008
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Eating Disorders
Behavioral: Structured Behavioral Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anorexia Nervosa: The Importance of Treatment Intensity

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Weight [ Time Frame: Measured over 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Eating behaviors [ Time Frame: Measured over 18 months ] [ Designated as safety issue: No ]
  • Psychopathology associated with eating behaviors [ Time Frame: Measured over 18 months ] [ Designated as safety issue: No ]
  • Utilization of health care services [ Time Frame: Measured over 18 months ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: February 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continued inpatient treatment
Participants will undergo inpatient hospital treatment until they have gained enough weight to be discharged.
Behavioral: Structured Behavioral Treatment
Daily therapy sessions and a weight gain protocol involving set meals and exercise levels
Experimental: Sequenced treatment
Participants will begin with inpatient treatment, transition to day patient treatment, and then transition to outpatient treatment.
Behavioral: Structured Behavioral Treatment
Daily therapy sessions and a weight gain protocol involving set meals and exercise levels

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815815

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Evelyn Attia, MD Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00815815     History of Changes
Other Study ID Numbers: #4698, R34MH070597
Study First Received: December 29, 2008
Last Updated: August 8, 2013
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Anorexia Nervosa

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Eating Disorders
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014