Body Image, Eating Disorders
Conditions
Keywords
Body Image Flexibility, Eating Disorders, Acceptance and Commitment Therapy, Psychological Flexibility, Early Intervention
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.
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.
Interventions
BEHAVIORALFlexED
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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Noncurrent Multiple Baseline Experimental Design where subjects will serve as their own control. Participants will be randomized to different baseline durations.
Eligibility
Sex/Gender
ALL
Age
15 Years to 25 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5 | Every 2 weeks to 8 weeks and 12 weeks | 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. |
| Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10) | Every 2 weeks to 8 weeks and 12 weeks | A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability. |
| Change from Baseline in the Body-Image Stroop Bias Score | Every 2 weeks to 8 weeks and 12 weeks | 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. |
| Change from Baseline in Eye Gaze Fixations - Body-Image Related Images | Every 2 weeks to 8 weeks and 12 weeks | 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. |
| Change from Baseline in Heart Rate Variability when Viewing Body-Image Related Images | Every 2 weeks to 8 weeks and 12 weeks | 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. |
| Change from Baseline in Weight Concern Scale Score | Baseline, 8 weeks and 12 weeks | 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. |
| Change from Baseline in Eating Disorder Examination (EDE) | Baseline and 12 weeks | 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. |
Countries
United States
Contacts
CONTACTRhonda Merwin, PhD
Outcome results
None listed