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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REACH
Supportive Psychotherapy
Inpatient Behavioral Treatment
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Eating Disorders, Psychotherapy, Anorexia Nervosa, Treatment

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

REACH

Supportive Psychotherapy

Arm Description

Psychotherapy

Psychotherapy

Outcomes

Primary Outcome Measures

Habit strength as measured by self report scales

Secondary Outcome Measures

Eating behavior as measured by laboratory meal
Eating behavior as measured by meal observation

Full Information

First Posted
January 29, 2015
Last Updated
September 12, 2017
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02382055
Brief Title
Changing Habits in Anorexia Nervosa: Novel Treatment Development
Acronym
REACH
Official Title
Changing Habits in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Eating Disorders, Psychotherapy, Anorexia Nervosa, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REACH
Arm Type
Experimental
Arm Description
Psychotherapy
Arm Title
Supportive Psychotherapy
Arm Type
Active Comparator
Arm Description
Psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
REACH
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psychotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Inpatient Behavioral Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Habit strength as measured by self report scales
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Eating behavior as measured by laboratory meal
Time Frame
4 weeks
Title
Eating behavior as measured by meal observation
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Steinglass, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16868087
Citation
Foerde K, Knowlton BJ, Poldrack RA. Modulation of competing memory systems by distraction. Proc Natl Acad Sci U S A. 2006 Aug 1;103(31):11778-83. doi: 10.1073/pnas.0602659103. Epub 2006 Jul 25.
Results Reference
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PubMed Identifier
15800147
Citation
McIntosh VV, Jordan J, Carter FA, Luty SE, McKenzie JM, Bulik CM, Frampton CM, Joyce PR. Three psychotherapies for anorexia nervosa: a randomized, controlled trial. Am J Psychiatry. 2005 Apr;162(4):741-7. doi: 10.1176/appi.ajp.162.4.741.
Results Reference
background
PubMed Identifier
23864536
Citation
McGowan L, Cooke LJ, Gardner B, Beeken RJ, Croker H, Wardle J. Healthy feeding habits: efficacy results from a cluster-randomized, controlled exploratory trial of a novel, habit-based intervention with parents. Am J Clin Nutr. 2013 Sep;98(3):769-77. doi: 10.3945/ajcn.112.052159. Epub 2013 Jul 17.
Results Reference
background
PubMed Identifier
23429750
Citation
Walsh BT. The enigmatic persistence of anorexia nervosa. Am J Psychiatry. 2013 May;170(5):477-84. doi: 10.1176/appi.ajp.2012.12081074.
Results Reference
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Changing Habits in Anorexia Nervosa: Novel Treatment Development

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