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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT02382055
First received: January 29, 2015
Last updated: September 12, 2017
Last verified: September 2017
  Purpose
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 Intervention
Anorexia Nervosa Behavioral: REACH Behavioral: Supportive Psychotherapy Behavioral: Inpatient Behavioral Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changing Habits in Anorexia Nervosa

Further study details as provided by New York State Psychiatric Institute:

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

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

Enrollment: 20
Actual Study Start Date: September 2015
Study Completion Date: June 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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