FlexED: Full Threshold ED Substudy

NCT07732829 | Not Yet Recruiting

• 1 other identifier: Pro00111571_3
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5

  Self-report measure of body-image psychological flexibility. The measure consists of 5 items that ask about the degree to which thoughts and feelings about the body interfere with living. Higher scores indicate greater flexibility/adaptability.

  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)

  A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability.

  Every 2 weeks to 8 weeks and 12 weeks

• Change from Baseline in the Body-Image Stroop Bias Score

  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.

  Every 2 weeks to 8 weeks and 12 weeks

• Change from Baseline in Eye Gaze Fixations - Body-Image Related Images

  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.

  Every 2 weeks to 8 weeks and 12 weeks

• Change from Baseline in Heart Rate Variability when Viewing Body-Image Related Images

  Heart rate variability measured with BIOPAC during the viewing of body-image related images, including idealized bodies, overweight bodies, body-weight measurement, and images of binge eating and body-related distress. Increases indicate greater flexibility/adaptability.

  Every 2 weeks to 8 weeks and 12 weeks

• Change from Baseline in Weight Concern Scale Score

  5-item measure of weight concerns (worry about weight, fear of weight gain, dieting history, importance of weight, fear of fatness). Elevated scores have been associated with the development of eating disorders.

  Baseline, 8 weeks and 12 weeks

• Change from Baseline in Eating Disorder Examination (EDE)

  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 and 12 weeks

Study Arms (3)

2-Week Baseline Duration

EXPERIMENTAL

baseline 0, 2 additional weeks of assessment, then 8 weeks of intervention

Behavioral: FlexED

4-Week Baseline Duration

EXPERIMENTAL

baseline 0, 4 additional weeks of assessment, then 8 weeks of intervention

Behavioral: FlexED

6-Week Baseline Duration

EXPERIMENTAL

baseline 0, 6 additional weeks of assessment, then 8 weeks of intervention

Behavioral: FlexED

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.

2-Week Baseline Duration; 4-Week Baseline Duration; 6-Week Baseline Duration

Eligibility Criteria

• Age: 15 Years - 25 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Rhonda Merwin, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Noncurrent Multiple Baseline Experimental Design where subjects will serve as their own control. Participants will be randomized to different baseline durations.

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)