NCT02382055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

January 29, 2015

Last Update Submit

September 12, 2017

Conditions

Anorexia Nervosa

Keywords

Eating DisordersPsychotherapyAnorexia NervosaTreatment

Outcome Measures

Primary Outcomes (1)

  • Habit strength as measured by self report scales

    4 weeks

Secondary Outcomes (2)

  • Eating behavior as measured by laboratory meal

    4 weeks

  • Eating behavior as measured by meal observation

    4 weeks

Study Arms (2)

REACH

EXPERIMENTAL

Psychotherapy

Behavioral: REACHBehavioral: Inpatient Behavioral Treatment

Supportive Psychotherapy

ACTIVE COMPARATOR

Psychotherapy

Behavioral: Supportive PsychotherapyBehavioral: Inpatient Behavioral Treatment

Interventions

REACHBEHAVIORAL

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.

REACH
Supportive PsychotherapyBEHAVIORAL

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.

Supportive Psychotherapy
Inpatient Behavioral TreatmentBEHAVIORAL

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.

REACHSupportive Psychotherapy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Other psychiatric disorder requiring acute treatment
  • Serious medical illness
  • Antipsychotic medication
  • Severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related 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. doi: 10.1073/pnas.0602659103. Epub 2006 Jul 25.

    PMID: 16868087BACKGROUND

  • 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.

    PMID: 15800147BACKGROUND

  • 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.

    PMID: 23864536BACKGROUND

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

    PMID: 23429750BACKGROUND

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joanna Steinglass, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

March 6, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

US(1)