Relapse Prevention and Changing Habits in Anorexia Nervosa

NCT04810624 | Suspended

• 2 other identifiers: 8110R34MH127180
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• Weight maintenance

  Measured via rate of weight loss (in lbs) following discharge from inpatient unit

  6-month end of treatment

Secondary Outcomes (5)

• Habit strength

  6-month end of treatment

• Weight/shape distortion

  6-month end of treatment

• Intrinsic motivation

  6-month end of treatment

• Dietary restriction

  6-month end of treatment

• Skill consolidation

  6-month end of treatment

Study Arms (26)

Do, Accept, Motivation Through Values, Sessions, Long-Term Food Logs,

EXPERIMENTAL

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+)

Do, Accept, Motivation through Values, Sessions, Short-Term Food Logs

EXPERIMENTAL

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+)

Do, Accept, Motivation through Values, Check-Ins, Short-Term Food Logs

EXPERIMENTAL

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+)

Do, Accept, Motivation through Values, Check-Ins, No Food Logs

EXPERIMENTAL

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+)

Do, Accept, Motivation through Narratives, Sessions, Short-Term Food Logs

EXPERIMENTAL

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+)

Do, Accept, Motivation through Narratives, Sessions, No Food Logs

EXPERIMENTAL

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+)

Do, Accept, Motivation through Narratives, Check-Ins, Long-Term Food Logs

EXPERIMENTAL

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+)

Do, Change, Motivation Through Values, Sessions, Short-Term Food Logs

EXPERIMENTAL

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+)

Do, Change, Motivation Through Values, Sessions, No Food Logs

EXPERIMENTAL

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+)

Do, Change, Motivation through Values, Check-Ins, Long-Term Food Logs

EXPERIMENTAL

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+)

Do, Change, Motivation Through Narratives, Sessions, Long-term Food Logs

EXPERIMENTAL

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+)

Talk, Accept, Motivation through Values, Sessions, Short-Term Food Logs

EXPERIMENTAL

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+)

Talk, Accept, Motivation through Values, Sessions, No Food Logs

EXPERIMENTAL

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+)

Talk, Accept, Motivation through Narratives, Check-Ins, Short-Term Food Logs

EXPERIMENTAL

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+)

Talk, Accept, Motivation through Narratives, Check-Ins, No Food Logs

EXPERIMENTAL

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+)

Talk, Change, Motivation Through Values, Sessions, Long-Term Food Logs

EXPERIMENTAL

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+)

Talk, Change, Motivation Through Values, Sessions, No Food Logs

EXPERIMENTAL

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+)

Talk, Change, Motivation through Values, Check-Ins, Short-Term Food Logs

EXPERIMENTAL

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+)

Talk, Change, Motivation through Values, Check-Ins, No Food Logs

EXPERIMENTAL

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+)

Talk, Change, Motivation through Narratives, Sessions, Short-Term Food Logs

EXPERIMENTAL

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+)

Talk, Change, Motivation through Narratives, Sessions, No Food Logs

EXPERIMENTAL

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+)

Talk, Change, Motivation through Narratives, Check-Ins, Long-Term Food Logs

EXPERIMENTAL

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+)

Do, Change, Motivation through Narratives, Check-Ins, Short-Term Food Logs

EXPERIMENTAL

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+)

Do, Change, Motivation through Narratives, Check-Ins, No Food Logs

EXPERIMENTAL

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+)

Talk, Accept, Motivation through Values, Check-Ins, Long-Term Food Logs

EXPERIMENTAL

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+)

Talk, Accept, Motivation through Narratives, Sessions, Long-Term Food Logs

EXPERIMENTAL

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+)

Interventions

Relapse Prevention and Changing Habits (REACH+) BEHAVIORAL

Psychotherapy

Do, Accept, Motivation Through Values, Sessions, Long-Term Food Logs,; Do, Accept, Motivation through Narratives, Check-Ins, Long-Term Food Logs; Do, Accept, Motivation through Narratives, Sessions, No Food Logs; Do, Accept, Motivation through Narratives, Sessions, Short-Term Food Logs; Do, Accept, Motivation through Values, Check-Ins, No Food Logs; Do, Accept, Motivation through Values, Check-Ins, Short-Term Food Logs; Do, Accept, Motivation through Values, Sessions, Short-Term Food Logs; Do, Change, Motivation Through Narratives, Sessions, Long-term Food Logs; Do, Change, Motivation Through Values, Sessions, No Food Logs; Do, Change, Motivation Through Values, Sessions, Short-Term Food Logs; Do, Change, Motivation through Narratives, Check-Ins, No Food Logs; Do, Change, Motivation through Narratives, Check-Ins, Short-Term Food Logs; Do, Change, Motivation through Values, Check-Ins, Long-Term Food Logs; Talk, Accept, Motivation through Narratives, Check-Ins, No Food Logs; Talk, Accept, Motivation through Narratives, Check-Ins, Short-Term Food Logs; Talk, Accept, Motivation through Narratives, Sessions, Long-Term Food Logs; Talk, Accept, Motivation through Values, Check-Ins, Long-Term Food Logs; Talk, Accept, Motivation through Values, Sessions, No Food Logs; Talk, Accept, Motivation through Values, Sessions, Short-Term Food Logs; Talk, Change, Motivation Through Values, Sessions, Long-Term Food Logs; Talk, Change, Motivation Through Values, Sessions, No Food Logs; Talk, Change, Motivation through Narratives, Check-Ins, Long-Term Food Logs; Talk, Change, Motivation through Narratives, Sessions, No Food Logs; Talk, Change, Motivation through Narratives, Sessions, Short-Term Food Logs; Talk, Change, Motivation through Values, Check-Ins, No Food Logs; Talk, Change, Motivation through Values, Check-Ins, Short-Term Food Logs

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current substance use or other comorbid disorder requiring specialized treatment
• Pregnancy
• Imminent risk of suicide
• Serious medical illness
• 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.

Sponsors & Collaborators

• Columbia University: collaborator
• Brown University: collaborator
• National Institute of Mental Health (NIMH): collaborator
• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related 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.

  PMID: 35488866 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: March 23, 2021
• Study Start: June 21, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)