REACH+: Relapse Prevention and Changing Habits in Anorexia Nervosa

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04810624
Collaborator
Columbia University (Other), Brown University (Other)
60
1
26
43.3
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Relapse Prevention and Changing Habits (REACH+)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Optimizing Relapse Prevention and Changing Habits in Anorexia Nervosa
Actual Study Start Date :
Jun 21, 2021
Anticipated Primary Completion Date :
Jan 30, 2025
Anticipated Study Completion Date :
Jan 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Weight maintenance [6-month end of treatment]

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

Secondary Outcome Measures

  1. Habit strength [6-month end of treatment]

    Measured via Self-Report Habit Index (SRHI)

  2. Weight/shape distortion [6-month end of treatment]

    Measured via Eating Disorder Examination, Questionnaire Version (EDE-Q)

  3. Intrinsic motivation [6-month end of treatment]

    Measured via General Self-Efficacy Scale (GSES)

  4. Dietary restriction [6-month end of treatment]

    Measured via Food Choice Task

  5. Skill consolidation [6-month end of treatment]

    Measured via platform utilization time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York State Psychiatric Institute New York New York United States 10032

Sponsors and Collaborators

  • New York State Psychiatric Institute
  • Columbia University
  • Brown University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Joanna Steinglass, Professor of Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT04810624
Other Study ID Numbers:
  • 8110
First Posted:
Mar 23, 2021
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022