Relapse Prevention and Changing Habits in Anorexia Nervosa

Not Applicable

Suspended

• Conditions: Anorexia Nervosa

• Registration Number: NCT04810624
• Lead Sponsor: New York State Psychiatric Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-23
• Study Start: 2021-06-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Weight maintenance	6-month end of treatment	Measured via rate of weight loss (in lbs) following discharge from inpatient unit

Secondary Outcome Measures

Name	Time	Method
Dietary restriction	6-month end of treatment	Measured via Food Choice Task
Habit strength	6-month end of treatment	Measured via Self-Report Habit Index (SRHI)
Skill consolidation	6-month end of treatment	Measured via platform utilization time
Weight/shape distortion	6-month end of treatment	Measured via Eating Disorder Examination, Questionnaire Version (EDE-Q)
Intrinsic motivation	6-month end of treatment	Measured via General Self-Efficacy Scale (GSES)

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States