Recruiting

ACT

Sponsor:

Duke University

Code:

NCT07632248

Conditions

Eating Disorders

Body Image

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Interventions

FlexED

Educational Control

Study Details

Brief summary:

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.

Conditions

Eating Disorders

Body Image

Study ID

NCT07632248

Start date

Jun 15, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: "FlexED"

Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.

active comparator: Educational Control

Seven 20-minute online education sessions about eating disorders.

Interventions

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.

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.

Primary outcome measure

  • Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ) [ Time Frame: Baseline, 4, 8, 12, 24, 36, 48 weeks ]
  • Change from Baseline in the Body-Image Stroop Bias Score [ Time Frame: Baseline, 8 weeks, 24 weeks ]
  • Change from Baseline in Eye Gaze Fixations - Body-Image Related Images [ Time Frame: Baseline, 8 weeks, 24 weeks ]
  • Acceptability of the intervention [ Time Frame: 8 weeks ]
  • Change from Baseline in Eating Disorder Examination (EDE) [ Time Frame: Baseline, 12 weeks, 24 weeks ]
  • Change from Baseline in the Eating Disorder Examination - Questionnaire (EDE-Q) [ Time Frame: Baseline, 12, 24, 36, 48 weeks ]
  • Change from Baseline in the Clinical Impairment Assessment (CIA) [ Time Frame: Baseline, 12, 24, 36, 48 weeks ]
  • Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10) [ Time Frame: Baseline, 4, 8, 12, 24, 36, 48 weeks ]
  • Change from Baseline in Daily Levels of Body Image Distress and Psychological Flexibility [ Time Frame: Baseline, 8 Weeks ]

Central Contacts and Locations

Central contacts

Rhonda M Merwin, Ph.D.

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

Dottie R Mayo

919-668-1935drm72@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Dottie R Mayo

919-668-1935drm72@duke.edu

Principal Investigator:

Rhonda M Merwin, Ph.D.

More Information

Sponsor

Duke University

Last update posted

Aug 28, 2026

Last verified

Jun, 2026

Keywords

  • Eating Disorders
  • Body Image Flexibility
  • 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 2026-08-28.