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

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

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.

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

• 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

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

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

• 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

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

Publications:

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. Epub 2006 Jul 25.

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.

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.

Walsh BT. The enigmatic persistence of anorexia nervosa. Am J Psychiatry. 2013 May;170(5):477-84. doi: 10.1176/appi.ajp.2012.12081074. Review.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT02382055
• Other Study ID Numbers: 7072
• First Posted: March 6, 2015
• 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