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Changing Habits in Anorexia Nervosa: Novel Treatment Development (REACH)

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ClinicalTrials.gov Identifier: NCT02382055
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Description
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Brief Summary:
The investigators are examining what types of psychotherapy are most helpful for patients as they undergo weight restoration treatment for anorexia nervosa. In this study, patients who are receiving care on our inpatient unit will also receive 4 weeks of one two types of psychotherapy: Supportive Psychotherapy or Regulation Emotions and Changing Habits.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: REACH Behavioral: Supportive Psychotherapy Behavioral: Inpatient Behavioral Treatment Not Applicable

Detailed Description:

Patients will be receiving specialized inpatient treatment for anorexia nervosa on the Eating Disorders Unit at the New York State Psychiatric Institute, where care is provided free of charge.

Study procedures will begin after one week of acclimating to the inpatient unit. Patients will be randomly assigned to receive either Supportive Psychotherapy (focused on the transition to the inpatient unit) or REACH (focused on changing routines or habits that have become part of the eating disorder). Each treatment consists of 12-sessions, delivered 2-3 times per week.

Before and after treatment, patients will be asked to participate in interviews, questionnaires, and a lunch meal.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changing Habits in Anorexia Nervosa
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: REACH
Psychotherapy
 Behavioral: REACH
REACH is a 12-session intervention, delivered 2-3 times per week for 45 minutes. The treatment focuses on identifying and changing behaviors and routines that have become entrenched and help perpetuate the illness.

Behavioral: Inpatient Behavioral Treatment
Inpatient treatment at the NYSPI is a behaviorally-based treatment program for anorexia nervosa. This is a non-research, clinical intervention for individuals with anorexia nervosa.
Active Comparator: Supportive Psychotherapy
Psychotherapy
 Behavioral: Supportive Psychotherapy
The Supportive Psychotherapy is based on the Specialist Supportive Care (McIntosh et al, 2005), and modified for the current research procedures. Supportive Psychotherapy is a 12-session intervention, delivered 2-3 times per week as 45 minute sessions, focusing on symptoms of anorexia nervosa during the transition to the inpatient unit.

Behavioral: Inpatient Behavioral Treatment
Inpatient treatment at the NYSPI is a behaviorally-based treatment program for anorexia nervosa. This is a non-research, clinical intervention for individuals with anorexia nervosa.


Outcome Measures
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Primary Outcome Measures :
  1. Habit strength as measured by self report scales [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Eating behavior as measured by laboratory meal [ Time Frame: 4 weeks ]
  2. Eating behavior as measured by meal observation [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM5 diagnosis of anorexia nervosa
  • Age>= 18
  • Medically stable
  • Able to provide informed consent

Exclusion Criteria:

  • Other psychiatric disorder requiring acute treatment
  • Serious medical illness
  • Antipsychotic medication
  • Severe cognitive impairment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382055


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: Joanna Steinglass, MD New York State Psychiatric Institute
More Information
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Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02382055     History of Changes
Other Study ID Numbers: 7072
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by New York State Psychiatric Institute:
Eating Disorders
Psychotherapy
Anorexia Nervosa
Treatment

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