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A Randomized Controlled Trial Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")

2026년 8월 26일 업데이트: Duke University

A Randomized Controlled Trial Testing Mechanism Engagement and Clinical Impact of FlexED: A Digital, Gamified Early Intervention for Eating Disorders

The goal of this clinical trial is to test whether a new digital intervention decreases eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body.

The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants will be randomly assigned (like a coin toss) to either the new digital intervention or education modules completed online.

The main questions are:

Does the digital intervention change how participants experience thoughts and feelings about their body or how they react to eating disorder triggers (e.g., images of idealized bodies)? Do these changes lead to decreases in eating disorder symptoms? Is the intervention acceptable and at the right dose?

Participants will:

Complete seven brief digital sessions over about 8 weeks. Complete interviews, surveys and lab assessments of reaction to body-related words and images.

Participants are followed for about 1 year.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

128

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Dottie R Mayo
  • 전화번호: 919-668-1935
  • 이메일: drm72@duke.edu

연구 장소

  • 미국
    • North Carolina
      • Durham, North Carolina, 미국, 27705
        • 모병
        • Duke University
        • 수석 연구원:
          • Rhonda M Merwin, Ph.D.
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Female between the age of 15-25 years old.
  • Weight Concerns Scale score of >=47.
  • Endorses one or more eating disorder behaviors (e.g., extreme dieting or exercise, subjective or objective binge eating, purging behaviors).

Exclusion Criteria:

  • Currently meets the DSM-5 diagnostic criteria for full threshold anorexia nervosa, bulimia nervosa or binge eating disorder, or for an eating or feeding disorder that does not include body-image or weight related distress and is not the focus of study (e.g., ARFID, PICA) or a past diagnosis of one of these disorders.
  • Change in psychotropic medications in the past month.
  • Active suicidal ideation, current substance use disorder or diagnosed psychotic disorder.
  • Bipolar disorder not being treated with medication.
  • Currently in treatment for an eating disorder.
  • Non-English speaking.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: "FlexED"
Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.
행동: FlexED
Intervention consists of seven 20-minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn psychological flexibility skills for body-image distress by completing interactive exercises and games with a relatable character and story line and receive rewards that reinforce learning.
활성 비교기: Educational Control
Seven 20-minute online education sessions about eating disorders.
행동: Educational Control
Intervention consists of seven digital online sessions of education about eating disorders and body image. Participants read information about how eating disorders develop and their impact on health and well-being and body image, watch videos and complete quizzes to check knowledge.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)
기간: Baseline, 4, 8, 12, 24, 36, 48 weeks
Self-report measure of body-image psychological flexibility. The measure consists of 13 (full measure) or 5 (short measure) items that ask about the degree to which thoughts and feelings about the body interfere with living. Higher scores indicate greater flexibility/adaptability.
Baseline, 4, 8, 12, 24, 36, 48 weeks
Change from Baseline in the Body-Image Stroop Bias Score
기간: Baseline, 8 weeks, 24 weeks
Change in reaction time to body-related versus neutral words in an emotional stroop paradigm. In this paradigm, participants identify the color of the written word as quickly as possible. Differences in reaction time between emotionally relevant words and neutral words is calculated as a bias score. Lower bias scores indicate improvement.
Baseline, 8 weeks, 24 weeks
Change from Baseline in Eye Gaze Fixations - Body-Image Related Images
기간: Baseline, 8 weeks, 24 weeks
Change in the number of fixations on body-image related images, including idealized bodies, overweight bodies, body-weight measurement, and images of binge eating and body-related distress. Fewer fixations indicate improvement.
Baseline, 8 weeks, 24 weeks
Acceptability of the intervention
기간: 8 weeks
Enrollment targets met, >70% of participants that start the intervention will complete >80%, >70% of participants and sessions will have user inputs indicating engagement.
8 weeks
Change from Baseline in Eating Disorder Examination (EDE)
기간: Baseline, 12 weeks, 24 weeks
Clinician-administered interview assessing eating disorder symptom severity, producing a Global score (main outcome) and 4 Subscale scores: Restraint, Eating Concerns, Weight Concerns, Shape Concerns. Higher scores indicate greater symptomatology.
Baseline, 12 weeks, 24 weeks
Change from Baseline in the Eating Disorder Examination - Questionnaire (EDE-Q)
기간: Baseline, 12, 24, 36, 48 weeks
Questionnaire format of the clinician-administered interview assessing eating disorder symptom severity, producing a Global score (main outcome) and 4 Subscale scores: Restraint, Eating Concerns, Weight Concerns, Shape Concerns. Higher scores indicate greater symptomatology.
Baseline, 12, 24, 36, 48 weeks
Change from Baseline in the Clinical Impairment Assessment (CIA)
기간: Baseline, 12, 24, 36, 48 weeks
Measures the extent to which eating disorder symptoms impair functioning. Higher scores indicate greater impairment.
Baseline, 12, 24, 36, 48 weeks
Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)
기간: Baseline, 4, 8, 12, 24, 36, 48 weeks
A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability.
Baseline, 4, 8, 12, 24, 36, 48 weeks
Change from Baseline in Daily Levels of Body Image Distress and Psychological Flexibility
기간: Baseline, 8 Weeks
4 days of ecological momentary assessment of 1) distress/body-image distress 2) problematic behaviors to change body weight/shape, 3) general attempts to suppress/get rid of unwanted thoughts and feelings, 4) avoiding doing things because of concern about body, and 5) the ability to maintain adaptive distance and 6) orient to values. Scaled items are on a Likert Scale 1=Not at All to 6=Very Much. For items 1-4, higher scores are more problematic; For items 5-6, higher scores are more flexible adaptive.
Baseline, 8 Weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Heart Rate when Viewing Emotional Film Clips
기간: Baseline, 8 weeks, 24 weeks
Heart rate and heart rate variability measured with BIOPAC during the viewing of film clips (neutral, emotional-general, emotional-body-image related). Increases indicate greater flexibility/adaptability.
Baseline, 8 weeks, 24 weeks
Change from Baseline in Cognitive Flexibility - Set-Shifting as assessed by the Wisconsin Card Sort Test (WCST)
기간: Baseline, 24 weeks
68-item computerized version of the WCST using default settings; perseverative errors. Decreases in errors indicates greater cognitive flexibility/adaptability.
Baseline, 24 weeks
Change from Baseline in Response Inhibition as assessed by Go/No-Go Task
기간: Baseline, 8 weeks, 24 weeks
The Go/No-Go task measures ability to inhibit a response when signaled (among other outcomes), measured by commission errors (frequency of responding when signaled to not respond); Other indices include sensitivity (ability to discriminate go/no go trials) and reaction time to go stimuli. Commission errors are of primary interest; decreases indicate reductions in impulsivity / improvement.
Baseline, 8 weeks, 24 weeks

기타 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in the Body Dissatisfaction Subscale of the Eating Disorder Inventory-3
기간: Baseline, 8 Weeks
EDI-3 Body Dissatisfaction (BD) Subscale, 10 items assessing contentment with specific body parts on a 6-point Likert scale (alternative mechanism of change). Higher scores indicate greater symptomatology.
Baseline, 8 Weeks
Change from Baseline in Problematic Social Media Use as assessed by the Bergen Social Media Addiction Scale
기간: Baseline, 12 Weeks
4-item scale assessing the extent to which social media use interfered or caused problems in life, with an additional item of hours of use (exploratory). Decreases indicate improvement.
Baseline, 12 Weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Duke University

협력자

National Institute of Mental Health (NIMH)

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 15일

기본 완료 (추정된)

2028년 7월 15일

연구 완료 (추정된)

2028년 7월 31일

연구 등록 날짜

최초 제출

2026년 6월 1일

QC 기준을 충족하는 최초 제출

2026년 6월 1일

처음 게시됨 (실제)

2026년 6월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 26일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Pro00111571_1

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

IPD will be shared in the NIMH National Data Archive (NDA).

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다