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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Joanna Steinglass, MD
- Telefonní číslo: 646-774-6345
- E-mail: js1124@cumc.columbia.edu
Studijní místa
-
-
New York
-
New York, New York, Spojené státy, 10032
- New York State Psychiatric Institute
-
Kontakt:
- Joanna Steinglass, MD
- Telefonní číslo: 646-774-6345
- E-mail: js1124@cumc.columbia.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Weight maintenance
Časové okno: 6-month end of treatment
|
Measured via weight loss (in lbs) following discharge from acute treatment program |
6-month end of treatment
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Habit strength
Časové okno: 6-month end of treatment
|
Measured via Self-Report Habit Index (SRHI) |
6-month end of treatment
|
|
Weight/shape distortion
Časové okno: 6-month end of treatment
|
Measured via Eating Disorder Examination, Questionnaire Version (EDE-Q) |
6-month end of treatment
|
|
Intrinsic motivation
Časové okno: 6-month end of treatment
|
Measured via General Self-Efficacy Scale (GSES) |
6-month end of treatment
|
|
Dietary restriction
Časové okno: 6-month end of treatment
|
Measured via Food Choice Task |
6-month end of treatment
|
|
Skill consolidation
Časové okno: 6-month end of treatment
|
Measured via platform utilization time |
6-month end of treatment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- NYSPI2025-82
- 1R01MH141008-01 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
This study will offer participants the opportunity to share data with the National Data Archive. This is not a requirement of participation.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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