Relapse Prevention and Changing Habits in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— REACH+  

Official title:

Optimizing Relapse Prevention and Changing Habits in Anorexia Nervosa

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04810624
• Other study ID #: 8110
• Secondary ID: R34MH127180
• Status: Suspended
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: January 30, 2025

Study information

• Verified date: August 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package.

In the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospitalization. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status.

Description:

While many approaches to reducing relapse after hospital care have been tried, there is little information about which treatment elements confer benefit. This trial, Relapse Prevention and Changing Habits (REACH+), targets the habitual control of maladaptive behavior to support patients with AN in the 6 months after acute treatment, a time of high vulnerability to relapse. Each component of REACH+ addresses a question that is critical to answer in order to identify and optimize a relapse prevention treatment package that balances efficacy and burden. We will test the acceptability and feasibility of 5 components that together target habits: 1) Behavioral, 2) Cognitive, 3)Motivation, 4) Food Monitoring, and 5) Skill Consolidation. In the Preparation Phase, 10 participants were enrolled, and accessibility and feasibility of the treatment package was examined. The current Optimization Phase includes a finalized treatment manual (including an online platform) and will test each component's contribution to weight maintenance after acute treatment.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Anorexia Nervosa at hospital admission

• Medically Stable

• Internet capability with videoconferencing

• Weight restored (BMI > 19 kg/m2) at New York State Psychiatric Institute

Exclusion Criteria:

• Current substance use or other comorbid disorder requiring specialized treatment

• Pregnancy

• Imminent risk of suicide

• Serious medical illness

• Daily psychotropic medication other than antidepressants (medications that are known effect weight are exclusionary, i.e. stimulants, olanzapine, mirtazapine)

• Participation in outside psychotherapy or structured treatment program (support groups will be allowed). Individuals who are discharged on medications would need to have a non-study psychiatrist.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• Relapse Prevention and Changing Habits (REACH+)
Psychotherapy

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Brown University, Columbia University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Steinglass JE, Attia E, Glasofer DR, Wang Y, Ruggiero J, Walsh BT, Thomas JG. Optimizing relapse prevention and changing habits (REACH+) in anorexia nervosa. Int J Eat Disord. 2022 Jun;55(6):851-857. doi: 10.1002/eat.23724. Epub 2022 Apr 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight maintenance	Measured via rate of weight loss (in lbs) following discharge from inpatient unit	6-month end of treatment
Secondary	Habit strength	Measured via Self-Report Habit Index (SRHI)	6-month end of treatment
Secondary	Weight/shape distortion	Measured via Eating Disorder Examination, Questionnaire Version (EDE-Q)	6-month end of treatment
Secondary	Intrinsic motivation	Measured via General Self-Efficacy Scale (GSES)	6-month end of treatment
Secondary	Dietary restriction	Measured via Food Choice Task	6-month end of treatment
Secondary	Skill consolidation	Measured via platform utilization time	6-month end of treatment