FlexED: Full Threshold ED Substudy
Purpose
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
Eligibility
- Eligible Ages
- Between 15 Years and 25 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Noncurrent Multiple Baseline Experimental Design where subjects will serve as their own control. Participants will be randomized to different baseline durations.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Duke University
Detailed Description
This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility eating disorder symptoms. Up to 6 young women and girls between the ages of 15-25 with full threshold eating disorder symptoms or diagnoses will complete an initial baseline assessment, and then be assigned to different assessment (baseline) periods ranging from 2-6 weeks. They will then complete 7 fully digital sessions over 8 weeks at home using their mobile phone. Psychological flexibility will be measured repeatedly via self-report and multi-level, multi-dimensional lab-based tasks assessing flexibility in cognition, affect and attention with body-image related stimuli during the baseline and treatment phases to estimate treatment effects. Eating disorder symptoms will also be assessed pre and post intervention.