FlexED: Full Threshold ED Substudy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-25
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female age 15-25 years
Weight Concerns Scale score of >=47
Meets diagnostic criteria for an eating disorder based on the DSM-5
Disqualifiers
Psychosis, substance use disorder, or current suicidal ideation or self-harm
Start or change in psychiatric medications within the past month
Non-English speaking
Trial design
Design model
Parallel
Treatments tested in this trial
FlexED
BehavioralIntervention 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.
Treatment groups
6 Participants
are divided into 3 treatment groupsGroup A: 2-Week Baseline DurationExperimental treatment 1 intervention
Group B: 4-Week Baseline DurationExperimental treatment 1 intervention
Group C: 6-Week Baseline DurationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Every 2 weeks to 8 weeks and 12 weeks2
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.
Time frame
Every 2 weeks to 8 weeks and 12 weeks3
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.
Time frame
Every 2 weeks to 8 weeks and 12 weeks4
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.
Time frame
Every 2 weeks to 8 weeks and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov