Eating Disorder Dynamic Intervention (EDDI)
15 maggio 2026 aggiornato da: Emily K. Presseller, Trustees of Dartmouth College
Rapid Innovation of Precision Psychiatry Interventions Using Dynamic Systems Modeling and Ecological Quasi-Experiments
The goal of this study is to develop and test a digital program to help people with eating disorders in their everyday lives.
The program uses brief surveys and sensor data collected by smartphones to understand when someone may be at higher risk for behaviors like restricting food, binge eating, or using unhealthy weight control behaviors.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
In this study, 170 adults with eating disorders will take part. They will regularly report on their thoughts, feelings, and behaviors throughout the day. Based on this information, the program will send "just-in-time" support, which involves short, tailored suggestions that encourage the use of helpful coping skills right when they are most needed.
The study has three main goals:
To better understand risk patterns:
The investigators will use real-time data to build personalized models that predict when someone is at higher risk for eating disorder behaviors based on their own data and patterns.
To test which therapy skills work best and why:
The investigators will examine how different evidence-based therapy skills (such as managing urges, improving mood, reducing strict dieting, and improving body image) help reduce eating disorder behaviors in daily life, and what psychological factors explain these effects.
- To evaluate the program's usability:
The investigators will assess whether participants find the digital support helpful, easy to use, and acceptable in their daily routines.
Tipo di studio
Interventistico
Iscrizione (Stimato)
170
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Emily K Presseller, PhD
- Numero di telefono: (203) 974-2949
- Email: emily.k.presseller@dartmouth.edu
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Age 18-70
- At least 12 ED behaviors from the same behavioral category in the past 12 weeks (i.e., at least 12 binge eating episodes, at least 12 compensatory behaviors, and/or at least 12 instances of dietary restriction)
- Ownership of a smartphone
- Willingness to complete ecological momentary assessment (EMA) and sensor data collection
- Live in the United States
- Has a primary care provider or is willing to establish a primary care provider
Exclusion Criteria:
- Inability to fluently speak, read, and write in English
- Body mass index < 17.5 kg/m2
- Medical complications of ED symptoms requiring immediate treatment
- Current ED-focused therapy
- Severe psychopathology (i.e., active suicidal ideation, psychosis, bipolar disorder, or substance use disorder) or intellectual disability inhibiting engagement in study protocols
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: All Participants Receive Just-In-Time Adaptive Interventions (JITAIs) through the EDDI App
All participants will receive just-in-time adaptive interventions when their personalized model identifies that they are at risk for an eating disorder behavior.
The content of the just-in-time adaptive intervention (i.e., the therapy skill targeted) will be randomized at the point of just-in-time adaptive intervention delivery.
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Participants will use a smartphone-based program designed to support eating disorder recovery in daily life.
Participants will complete brief surveys about their mood, thoughts, and behaviors, and the smartphone will also passively collect activity-related data.
This information is used to detect times when a person may be at higher risk for eating disorder behaviors.
Participants will watch 4 video modules that introduce the core enhanced cognitive-behavioral therapy skills for eating disorders (reducing dietary restraint, urge management, emotion regulation, and improving body image), provide rationale, and prompt participants to complete interactive activities to practice these skills.
Participants will then receive micro-randomized JITAIs prompting them to use these skills in their daily lives; micro-randomization will be used to deliver a JITAI from one of the 4 skill categories (reducing dietary restraint, urge management, emotion regulation, improving body image) or no JITAI.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Area under the receiver operating curve (AUC)
Lasso di tempo: Weeks 5 and 6 of data collection
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Performance of the eating disorder behavior prediction models will be evaluated by computing the area under the receiver operating curve (AUC) for each participants' models on two-weeks of held out (test) data (collected during weeks 5 and 6 of the data collection procedure).
The AUC can take on values between 0 and 1, with higher values indicating superior model performance.
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Weeks 5 and 6 of data collection
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Brier Score
Lasso di tempo: Weeks 5 and 6 of data collection
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Performance of the eating disorder behavior prediction models will be evaluated by computing the Brier score for each participants' models on two-weeks of held out (test) data (collected during weeks 5 and 6 of the data collection procedure).
The Brier score can range from 0 to 1 with lower values indicating less model error (i.e., better model performance).
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Weeks 5 and 6 of data collection
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Binge eating
Lasso di tempo: Weeks 7 through 16 of data collection
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Binge eating occurrence during the data collection protocol will be measured.
Binge eating at each ecological momentary assessment survey will be assessed by the question, "Thinking about your most recent eating episode, did you experience loss of control?" (Answer choices = Yes or No).
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Weeks 7 through 16 of data collection
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Dietary restriction
Lasso di tempo: Weeks 7 through 16 of data collection
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Dietary restriction will be measured during the data collection protocol.
Dietary restriction will be assessed at each ecological momentary assessment survey by the questions, "Thinking about your most recent eating episode, did you limit the amount of food you ate to influence your shape?", "Thinking about your most recent eating episode, did you exclude specific foods to influence your shape or weight?", and Since the last survey, have you skipped a meal or snack?" (Answer Choices = Yes or No).
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Weeks 7 through 16 of data collection
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Compensatory behaviors
Lasso di tempo: Weeks 7 through 16 of data collection
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Dietary restriction will be measured during the data collection protocol.
Dietary restriction will be assessed at each ecological momentary assessment survey by the questions, "Since the last survey, have you engaged in any of the following?
Self-induced vomiting," "Laxative use (to influence shape or weight)," "Diuretic use (to influence shape or weight)," "Diet pill use (to influence shape or weight)," "Exercise (to influence shape or weight)," and "Other behavior to influence shape or weight" (Answer Choices = Yes or No).
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Weeks 7 through 16 of data collection
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Feasibility and Acceptability Questionnaire
Lasso di tempo: End of study assessment (after week 16 of data collection)
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Acceptability will be evaluated via the Feasibility and Acceptability Questionnaire.
These data will be collected after participants have completed the 16 weeks of data collection using the EDDI app.
Mean ratings ≥ 5 (on the seven-point Likert rating scales) on acceptability items will be considered to indicate acceptability.
The response scale is as follows: 1=Strongly Disagree 2=Disagree 3=Disagree a little 4=Neither agree nor disagree 5=Agree a little 6=Agree 7=Strongly Agree, with higher scores indicating greater acceptability.
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End of study assessment (after week 16 of data collection)
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System Usability Scale
Lasso di tempo: End of study assessment (after week 16 of data collection)
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Acceptability will be evaluated via the System Usability Scale.
These data will be collected after participants have completed the 16 weeks of data collection using the EDDI app.
Mean ratings ≥ 4 (on the five-point Likert rating scale) on System Usability Scale items will be considered to indicate acceptability.
The response scale runs from 1 = Strongly Disagree (minimum value) to 5 = Strongly Agree (maximum value), with higher ratings indicating greater usability.
Items 2, 4, 6, 8, and 10 will be reverse coded to align with higher ratings indicating greater usability.
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End of study assessment (after week 16 of data collection)
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Percentage of Eligible Participants Enrolled
Lasso di tempo: Through study completion, an average of 4 months
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Feasibility of the EDDI app will be evaluated by computing the percentage of eligible participants enrolled.
This will be computed by dividing the number of enrolled participants by the total number of eligible participants and multiplying by 100.
At least 85% of eligible participants enrolled will be considered to demonstrate feasibility.
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Through study completion, an average of 4 months
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Attrition Rate
Lasso di tempo: Through study completion, an average of 4 months
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Feasibility of the EDDI app will be evaluated by computing the attrition (drop out) rate.
This will be computed by dividing the number of participants who discontinue the study prior to the end of study assessment by the total number of enrolled participants and multiplying by 100.
An attrition rate of less than 15% will be considered to demonstrate feasibility.
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Through study completion, an average of 4 months
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Percentage of JITAIs Producing Skill Use
Lasso di tempo: Through study completion, an average of 4 months
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Feasibility of the EDDI app will be evaluated by computing the percentage of JITAIs that produce participant-reported skill use.
This will be computed by dividing the instances of reported skills used by the total number of delivered JITAIs and multiplying by 100.
JITAIs producing skill use at least 80% of the time will be considered to demonstrate feasibility.
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Through study completion, an average of 4 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Body image concerns (Eating Disorder Examination Questionnaire-Short Form)
Lasso di tempo: Weeks 7 through 16 of data collection
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Body image concerns will be measured as a possible mediator of the effect of JITAIs on eating disorder behaviors.
Body image concerns will be quantified as the mean rating across the body image items on the Eating Disorder Examination Questionnaire-Short Form, adapted to be rated on a five-point Likert scale as follows: 0=Very slightly/not at all 1 = A little 2 =Moderately 3 = Quite a bit 4= Extremely.
Higher mean ratings indicate great body image concerns.
Minimum mean score on the items is 0 and maximum is 4.
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Weeks 7 through 16 of data collection
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Cognitive dietary restraint (Eating Disorder Examination-Questionnaire)
Lasso di tempo: Weeks 7 through 16 of data collection
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Cognitive dietary restraint will be measured as a possible mediator of the effects of JITAIs on eating disorder behaviors.
Cognitive dietary restraint is assessed by the mean score across four selected dietary restraint items from the Eating Disorder Examination Questionnaire, modified to be assessed on the following response scale: 0=Very slightly/not at all 1 = A little 2 =Moderately 3 = Quite a bit 4= Extremely.
The minimum mean score is 0 and the maximum mean score is 4, with higher scores indicating greater dietary restraint.
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Weeks 7 through 16 of data collection
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Negative affect (Positive and Negative Affect Schedule)
Lasso di tempo: Weeks 7 through 16 of data collection
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Negative affect will be measured as a possible mediator of the effects of JITAIs on eating disorder behaviors.
Negative affect is assessed by the mean score across six selected negative affect items (upset, hostile, ashamed, afraid, nervous, guilty from the Positive and Negative Affect Schedule, modified to be assessed on the following response scale: 0=Very slightly/not at all 1 = A little 2 =Moderately 3 = Quite a bit 4= Extremely.
The minimum mean score is 0 and the maximum mean score is 4, with higher scores indicating greater negative affect.
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Weeks 7 through 16 of data collection
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 maggio 2026
Completamento primario (Stimato)
31 gennaio 2030
Completamento dello studio (Stimato)
31 luglio 2030
Date di iscrizione allo studio
Primo inviato
4 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
15 maggio 2026
Primo Inserito (Effettivo)
22 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY00033481
- 1DP5OD039510-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
To facilitate open science, all de-identified data from the present study will be shared via National Data Archive (NDA), unless doing so would violate research ethics or privacy of participants (e.g., raw smartphone location sensor data will not be shared as this would violate participants' privacy and confidentiality).
In addition to the subject level data described above, subject level data on adherence to the ecological momentary assessment protocol and responsivity to just-in-time adaptive interventions will also be shared via NDA.
Periodo di condivisione IPD
Data will be made available starting 6 months after recruitment of the first participant and will continue indefinitely.
Criteri di accesso alla condivisione IPD
Study protocols and all intervention content (just-in-time adaptive intervention text, skill repository text, video modules) will be available upon request from the study team.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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 .
Prove cliniche su Eating Disorder Dynamic Intervention
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