Recruiting

ACT

Sponsor:

Duke University

Code:

NCT07732829

Conditions

Eating Disorders

Body Image

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Interventions

FlexED

Study Details

Brief summary:

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.

Conditions

Eating Disorders

Body Image

Study ID

NCT07732829

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female age 15-25 years
  • Weight Concerns Scale score of >=47
  • Meets diagnostic criteria for an eating disorder based on the DSM-5

Exclusion Criteria:

  • Psychosis, substance use disorder, or current suicidal ideation or self-harm
  • Start or change in psychiatric medications within the past month
  • Non-English speaking

Study Design

Enrollment

6 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

FlexED

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.

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 ]
  • Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10) [ Time Frame: Every 2 weeks to 8 weeks and 12 weeks ]
  • Change from Baseline in the Body-Image Stroop Bias Score [ Time Frame: Every 2 weeks to 8 weeks and 12 weeks ]
  • Change from Baseline in Eye Gaze Fixations - Body-Image Related Images [ Time Frame: Every 2 weeks to 8 weeks and 12 weeks ]
  • Change from Baseline in Heart Rate Variability when Viewing Body-Image Related Images [ Time Frame: Every 2 weeks to 8 weeks and 12 weeks ]
  • Change from Baseline in Weight Concern Scale Score [ Time Frame: Baseline, 8 weeks and 12 weeks ]
  • Change from Baseline in Eating Disorder Examination (EDE) [ Time Frame: Baseline and 12 weeks ]

Central Contacts and Locations

Central contacts

Rhonda Merwin, PhD

919-681-7231rhonda.merwin@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Dottie Mayo

919-668-1935dottie.mayo@duke.edu

Principal Investigator:

Rhonda M Merwin, PhD

More Information

Sponsor

Duke University

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Body Image Flexibility
  • Eating Disorders
  • Acceptance and Commitment Therapy
  • Psychological Flexibility
  • Early Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-03.