Relapse Prevention and Changing Habits in Anorexia Nervosa 2.0 (REACH+)
Making the MOST of Relapse Prevention in Anorexia Nervosa: A Treatment Optimization Study Targeting Habits
This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after structured treatment. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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. Using the Multiphase Optimization STrategy (MOST) framework, we seek to identify an optimized, finalized, treatment package for relapse prevention in AN. The MOST framework is an ideal means for improving treatment efficacy by simultaneously and efficiently evaluating multiple possible intervention components to determine which contribute to positive treatment outcomes and thereby merit inclusion in a robust treatment package for relapse prevention. We will test variations versions of intervention components that together support remission.
We will provide 6 months of REACH+ for 120 individuals with AN or atypical AN who have completed an acute weight-restoration treatment. REACH+ sessions are conducted via telehealth and are augmented with psychoeducation and skill building through an online platform. Participants will be randomly assigned to different versions of each treatment component. Optimization criteria focus on the contribution of the component to remission status (main effect), and will additionally consider effect sizes, treatment adherence, and end-of-treatment status.
To ensure that the final treatment package will reach the patients we seek to help, we will obtain input from key end-users to plan for future effectiveness research.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Joanna Steinglass, MD
- Numero di telefono: 646-774-6345
- Email: js1124@cumc.columbia.edu
Luoghi di studio
-
-
New York
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New York, New York, Stati Uniti, 10032
- New York State Psychiatric Institute
-
Contatto:
- Joanna Steinglass, MD
- Numero di telefono: 646-774-6345
- Email: js1124@cumc.columbia.edu
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- DSM-5 diagnosis of Anorexia Nervosa or Atypical Anorexia Nervosa
- Completed acute treatment, including achieving weight-restoration
- Has a medical treatment provider (e.g. primary care doctor) who can be made aware that the patient is participating in the study
- Medically stable
- Access to internet-connected device with videoconferencing capability
- Will reside (after acute treatment discharge) in a state where a study therapist is licensed
- Not seeking or engaging in additional psychotherapy outside of the study (support groups are allowed)
Exclusion Criteria:
- Current substance use disorder or other co-occurring psychiatric diagnoses that requires specialized treatment
- Pregnant
- High risk of suicide
- Current serious medical illness
- Daily medications that impact weight
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Do, Accept, Values, 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. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
Psychotherapy |
|
Sperimentale: Do, Accept, Values, 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: Idenitfying individual motivators for recovery and opportunities to expand upon non-eating disorder aspects of identity. Food-Monitoring - Short-Term: Use of food logs for first 6 weeks of treatment. |
Psychotherapy |
|
Sperimentale: Do, Accept, Values, 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. Food-Monitoring - None: No recommendation for food records or logs during treatment. |
Psychotherapy |
|
Sperimentale: Do, Accept, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
Psychotherapy |
|
Sperimentale: Do, Accept, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food-Monitoring - Short-Term: Use of food logs for first 6 weeks of treatment. |
Psychotherapy |
|
Sperimentale: Do, Accept, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food-Monitoring - None: No recommendation for food records or logs during treatment. |
Psychotherapy |
|
Sperimentale: Do, Change, Values, 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. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
Psychotherapy |
|
Sperimentale: Do, Change, Values, 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. Food-Monitoring - Short-Term: Use of food logs for first 6 weeks of treatment. |
Psychotherapy |
|
Sperimentale: Do, Change, Values, 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. Food-Monitoring - None: No recommendation for food records or logs during treatment. |
Psychotherapy |
|
Sperimentale: Do, Change, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
Psychotherapy |
|
Sperimentale: Do, Change, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food-Monitoring - Short-Term: Use of food logs for first 6 weeks of treatment. |
Psychotherapy |
|
Sperimentale: Do, Change, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food-Monitoring - None: No recommendation for food records or logs during treatment. |
Psychotherapy |
|
Sperimentale: Talk, Accept, Values, 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. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
Psychotherapy |
|
Sperimentale: Talk, Accept, Values, 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. Food-Monitoring - Short-Term: Use of food logs for first 6 weeks of treatment. |
Psychotherapy |
|
Sperimentale: Talk, Accept, Values, 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. Food-Monitoring - None: No recommendation for food records or logs during treatment. |
Psychotherapy |
|
Sperimentale: Talk, Accept, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
Psychotherapy |
|
Sperimentale: Talk, Accept, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food-Monitoring - Short-Term: Use of food logs for first 6 weeks of treatment. |
Psychotherapy |
|
Sperimentale: Talk, Accept, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food-Monitoring - None: No recommendation for food records or logs during treatment. |
Psychotherapy |
|
Sperimentale: Talk, Change, Values, 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. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
Psychotherapy |
|
Sperimentale: Talk, Change, Values, 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. Food-Monitoring - Short-Term: Use of food logs for first 6 weeks of treatment. |
Psychotherapy |
|
Sperimentale: Talk, Change, Values, 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. Food-Monitoring - None: No recommendation for food records or logs during treatment. |
Psychotherapy |
|
Sperimentale: Talk, Change, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food Monitoring - Long-Term: Use of food logs for duration of treatment. |
Psychotherapy |
|
Sperimentale: Talk, Change, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food-Monitoring - Short-Term: Use of food logs for first 5 weeks of treatment. |
Psychotherapy |
|
Sperimentale: Talk, Change, Narrative, 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., writing, podcasts) to appreciate long-term dangers of AN and the opportunity for symptom resolution with sustained recovery, without discussion of individualized motivators. Food-Monitoring - None: No recommendation for food records or logs during treatment. |
Psychotherapy |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Weight maintenance
Lasso di tempo: 6-month end of treatment
|
Measured via weight loss (in lbs) following discharge from acute treatment program |
6-month end of treatment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Habit strength
Lasso di tempo: 6-month end of treatment
|
Measured via Self-Report Habit Index (SRHI) |
6-month end of treatment
|
|
Weight/shape distortion
Lasso di tempo: 6-month end of treatment
|
Measured via Eating Disorder Examination, Questionnaire Version (EDE-Q) |
6-month end of treatment
|
|
Intrinsic motivation
Lasso di tempo: 6-month end of treatment
|
Measured via General Self-Efficacy Scale (GSES) |
6-month end of treatment
|
|
Dietary restriction
Lasso di tempo: 6-month end of treatment
|
Measured via Food Choice Task |
6-month end of treatment
|
|
Skill consolidation
Lasso di tempo: 6-month end of treatment
|
Measured via platform utilization time |
6-month end of treatment
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NYSPI2025-82
- 1R01MH141008-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
This study will offer participants the opportunity to share data with the National Data Archive. This is not a requirement of participation.
Informazioni su farmaci e dispositivi, documenti di studio
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .