Relapse Prevention and Changing Habits in Anorexia Nervosa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Relapse Prevention and Changing Habits in Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Behavioral: Relapse Prevention and Changing Habits (REACH+)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Do, Accept, Motivation Through Values, Sessions, Long-Term Food Logs,<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Accept, Motivation through Values, Sessions, Short-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Accept, Motivation through Values, Check-Ins, Short-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Accept, Motivation through Values, Check-Ins, No Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Accept, Motivation through Narratives, Sessions, Short-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Accept, Motivation through Narratives, Sessions, No Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Accept, Motivation through Narratives, Check-Ins, Long-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Change, Motivation Through Values, Sessions, Short-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Change, Motivation Through Values, Sessions, No Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Change, Motivation through Values, Check-Ins, Long-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Change, Motivation Through Narratives, Sessions, Long-term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Accept, Motivation through Values, Sessions, Short-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Accept, Motivation through Values, Sessions, No Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Accept, Motivation through Narratives, Check-Ins, Short-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Accept, Motivation through Narratives, Check-Ins, No Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Change, Motivation Through Values, Sessions, Long-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Change, Motivation Through Values, Sessions, No Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Change, Motivation through Values, Check-Ins, Short-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Change, Motivation through Values, Check-Ins, No Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Change, Motivation through Narratives, Sessions, Short-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Change, Motivation through Narratives, Sessions, No Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Change, Motivation through Narratives, Check-Ins, Long-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Change, Motivation through Narratives, Check-Ins, Short-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Do, Change, Motivation through Narratives, Check-Ins, No Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Accept, Motivation through Values, Check-Ins, Long-Term Food Logs<br>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+)<br>* Psychotherapy<br>|
| Experimental: Talk, Accept, Motivation through Narratives, Sessions, Long-Term Food Logs<br>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+)<br>* Psychotherapy<br>|

What is the study measuring?
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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 |