Eating Disorder Dynamic Intervention (EDDI)
2026年5月15日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
170
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Emily K Presseller, PhD
- 電話番号：(203) 974-2949
- メール：emily.k.presseller@dartmouth.edu
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Area under the receiver operating curve (AUC)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body image concerns (Eating Disorder Examination Questionnaire-Short Form)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月1日
一次修了 (推定)
2030年1月31日
研究の完了 (推定)
2030年7月31日
試験登録日
最初に提出
2026年5月4日
QC基準を満たした最初の提出物
2026年5月15日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22日
QC基準を満たした最後の更新が送信されました
2026年5月15日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00033481
- 1DP5OD039510-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
IPD 共有時間枠
Data will be made available starting 6 months after recruitment of the first participant and will continue indefinitely.
IPD 共有アクセス基準
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。