FlexED: Full Threshold ED Substudy

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07732829
Status
Not Yet Recruiting

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Conditions

  • Body Image
  • Eating Disorders

Eligibility Criteria

Sex
ALL
Age
15 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • FlexED — BEHAVIORAL
    Intervention consists of seven \~ 20-minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.

Study Details

The purpose of this study is to test whether a new digital intervention decreases eating disorder symptoms in young women with eating disorders by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants complete up to 7 digital intervention sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Researchers will examine the impact of the intervention on participants' ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye movements, and reaction time to body-image related words and images, and examine changes in eating disorder symptoms before and after intervention.

Key Dates

First listed
Jul 29, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
6 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2-Week Baseline Duration
    baseline 0, 2 additional weeks of assessment, then 8 weeks of intervention
  • Experimental: 4-Week Baseline Duration
    baseline 0, 4 additional weeks of assessment, then 8 weeks of intervention
  • Experimental: 6-Week Baseline Duration
    baseline 0, 6 additional weeks of assessment, then 8 weeks of intervention

Primary Outcome Measure

Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5 [ Time Frame: Every 2 weeks to 8 weeks and 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27705
Dottie Mayo
[email protected]
919-668-1935
Rhonda M Merwin, PhD (PRINCIPAL_INVESTIGATOR)

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