FlexED: National Substudy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorDuke University
About this trial
The purpose of this study is to test the feasibility of disseminating an intervention broadly. "FlexED" is a digital gamified intervention targeting 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 complete seven 20-minute sessions of the intervention using their smartphone over about 8 weeks. Participants also complete questionnaires bi-weekly as they go through the intervention. A final measurement is taken one month after the last digital intervention session. These surveys are all conducted online. Participants are in the study for up to 12 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female between the age of 18-25 years old.
Disqualifiers
Non-English speaking
Trial design
Design model
Single group
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 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: FlexEDExperimental 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. Scores range from 5-35, with higher scores indicating greater flexibility/adaptability.
Time frame
Baseline, Week 4, Week 8, Week 122
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. Openness scores range from 0-18, Awareness 0-18, and Engagement 0-24. Higher scores indicate greater flexibility/adaptability.
Time frame
Baseline, Week 4, Week 8, Week 123
Change 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). Scores range from 0-100, with elevated scores (scores \>= 47) having been associated with an increased risk of developing an eating disorder.
Time frame
Baseline, Week 8, Week 124
Change from Baseline in the Eating Disorder Examination Questionnaire - Short (EDE-QS)
Short questionnaire format (12 items) of the clinician-administered interview assessing eating disorder symptom severity. Scores range from 0-36, with higher scores indicating greater symptomatology.
Time frame
Baseline, Week 8, Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov