Changing Habits in Anorexia Nervosa: Novel Treatment Development

Anorexia Nervosa Clinical Trial

— REACH  

Official title:

Changing Habits in Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382055
• Other study ID #: 7072
• Status: Completed
• Phase: N/A
• First received: January 29, 2015
• Last updated: September 12, 2017
• Start date: September 2015
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Habit strength as measured by self report scales		4 weeks
Secondary	Eating behavior as measured by laboratory meal		4 weeks
Secondary	Eating behavior as measured by meal observation		4 weeks