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.
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Joanna Steinglass, MD
- Telefonnummer: 646-774-6345
- E-post: js1124@cumc.columbia.edu
Studiesteder
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New York
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New York, New York, Forente stater, 10032
- New York State Psychiatric Institute
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Ta kontakt med:
- Joanna Steinglass, MD
- Telefonnummer: 646-774-6345
- E-post: js1124@cumc.columbia.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Weight maintenance
Tidsramme: 6-month end of treatment
|
Measured via weight loss (in lbs) following discharge from acute treatment program |
6-month end of treatment
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Habit strength
Tidsramme: 6-month end of treatment
|
Measured via Self-Report Habit Index (SRHI) |
6-month end of treatment
|
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Weight/shape distortion
Tidsramme: 6-month end of treatment
|
Measured via Eating Disorder Examination, Questionnaire Version (EDE-Q) |
6-month end of treatment
|
|
Intrinsic motivation
Tidsramme: 6-month end of treatment
|
Measured via General Self-Efficacy Scale (GSES) |
6-month end of treatment
|
|
Dietary restriction
Tidsramme: 6-month end of treatment
|
Measured via Food Choice Task |
6-month end of treatment
|
|
Skill consolidation
Tidsramme: 6-month end of treatment
|
Measured via platform utilization time |
6-month end of treatment
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Samarbeidspartnere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
Andre studie-ID-numre
- NYSPI2025-82
- 1R01MH141008-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
This study will offer participants the opportunity to share data with the National Data Archive. This is not a requirement of participation.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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