Relapse Prevention and Changing Habits in Anorexia Nervosa (REACH+)

Optimizing Relapse Prevention and Changing Habits in Anorexia Nervosa

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.

Study Overview

• Status: Suspended
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Relapse Prevention and Changing Habits (REACH+)

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

26

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Do, Accept, Motivation Through Values, Sessions, Long-Term Food Logs,; Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food Monitoring - Long-Term: Use of food logs for duration of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Accept, Motivation through Values, Sessions, Short-Term Food Logs; Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Accept, Motivation through Values, Check-Ins, Short-Term Food Logs; Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Accept, Motivation through Values, Check-Ins, No Food Logs; Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. No Food-Monitoring: No recommendation for food records or logs during treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Accept, Motivation through Narratives, Sessions, Short-Term Food Logs; Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Accept, Motivation through Narratives, Sessions, No Food Logs; Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. No Food-Monitoring: No recommendation for food records or logs during treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Accept, Motivation through Narratives, Check-Ins, Long-Term Food Logs; Behavior Do: Including in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food Monitoring - Long-Term: Use of food logs for duration of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Change, Motivation Through Values, Sessions, Short-Term Food Logs; Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Change, Motivation Through Values, Sessions, No Food Logs; Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. No Food-Monitoring: No recommendation for food records or logs during treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Change, Motivation through Values, Check-Ins, Long-Term Food Logs; Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food Monitoring - Long-Term: Use of food logs for duration of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Change, Motivation Through Narratives, Sessions, Long-term Food Logs; Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food Monitoring - Long-Term: Use of food logs for duration of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Accept, Motivation through Values, Sessions, Short-Term Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Accept, Motivation through Values, Sessions, No Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. No Food-Monitoring: No recommendation for food records or logs during treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Accept, Motivation through Narratives, Check-Ins, Short-Term Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Accept, Motivation through Narratives, Check-Ins, No Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. No Food-Monitoring: No recommendation for food records or logs during treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Change, Motivation Through Values, Sessions, Long-Term Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food Monitoring - Long-Term: Use of food logs for duration of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Change, Motivation Through Values, Sessions, No Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. No Food-Monitoring: No recommendation for food records or logs during treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Change, Motivation through Values, Check-Ins, Short-Term Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Change, Motivation through Values, Check-Ins, No Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. No Food-Monitoring: No recommendation for food records or logs during treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Change, Motivation through Narratives, Sessions, Short-Term Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Change, Motivation through Narratives, Sessions, No Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. No Food-Monitoring: No recommendation for food records or logs during treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Change, Motivation through Narratives, Check-Ins, Long-Term Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food Monitoring - Long-Term: Use of food logs for duration of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Change, Motivation through Narratives, Check-Ins, Short-Term Food Logs; Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Do, Change, Motivation through Narratives, Check-Ins, No Food Logs; Behavior Do: Including in-session eating experiments. Thought Change: Monitoring and actively challenging distorted thoughts. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. No Food-Monitoring: No recommendation for food records or logs during treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Accept, Motivation through Values, Check-Ins, Long-Term Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Values: Identifying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Check-Ins for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress conducted independently by participant, with only brief (~20-min) check-ins during this period. Food Monitoring - Long-Term: Use of food logs for duration of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy
Experimental: Talk, Accept, Motivation through Narratives, Sessions, Long-Term Food Logs; Behavior Talk: Discussion of recent eating and plans for upcoming eating; absence of in-session eating experiments. Thought Accept: Mindfully accepting of unhelpful thoughts as passing mental phenomena that need not guide behavior. Motivation Through Narratives: Using stories of others with lived experience (e.g., writings, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Sessions for Skills Consolidation: Consolidation of skills introduced to patient and monitoring of continued progress using 45-min, face-to-face (via video) sessions. Food Monitoring - Long-Term: Use of food logs for duration of treatment.	Behavioral: Relapse Prevention and Changing Habits (REACH+); Psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight maintenance	Measured via rate of weight loss (in lbs) following discharge from inpatient unit	6-month end of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH); Columbia University; Brown University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 8110; R34MH127180 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No