Effectiveness of High Intensity Inpatient Versus Stepped Intensity Treatment for Anorexia Nervosa
Condition: Eating Disorders
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Interventional

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.
    

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.
    

Intervention name(s): Structured Behavioral Treatment
Intervention type(s): Behavioral
Intervention description(s): Daily therapy sessions and a weight gain protocol involving set meals and exercise levels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anorexia Nervosa