- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07927504
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Joanna Steinglass, MD
- Puhelinnumero: 646-774-6345
- Sähköposti: js1124@cumc.columbia.edu
Opiskelupaikat
-
-
New York
-
New York, New York, Yhdysvallat, 10032
- New York State Psychiatric Institute
-
Ottaa yhteyttä:
- Joanna Steinglass, MD
- Puhelinnumero: 646-774-6345
- Sähköposti: js1124@cumc.columbia.edu
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Tehtävätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Weight maintenance
Aikaikkuna: 6-month end of treatment
|
Measured via weight loss (in lbs) following discharge from acute treatment program |
6-month end of treatment
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Habit strength
Aikaikkuna: 6-month end of treatment
|
Measured via Self-Report Habit Index (SRHI) |
6-month end of treatment
|
|
Weight/shape distortion
Aikaikkuna: 6-month end of treatment
|
Measured via Eating Disorder Examination, Questionnaire Version (EDE-Q) |
6-month end of treatment
|
|
Intrinsic motivation
Aikaikkuna: 6-month end of treatment
|
Measured via General Self-Efficacy Scale (GSES) |
6-month end of treatment
|
|
Dietary restriction
Aikaikkuna: 6-month end of treatment
|
Measured via Food Choice Task |
6-month end of treatment
|
|
Skill consolidation
Aikaikkuna: 6-month end of treatment
|
Measured via platform utilization time |
6-month end of treatment
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- NYSPI2025-82
- 1R01MH141008-01 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
This study will offer participants the opportunity to share data with the National Data Archive. This is not a requirement of participation.
Lääke- ja laitetiedot, tutkimusasiakirjat
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