The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old. Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments. 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 gaze, and reaction time to body-image related words and images, and test how long it takes to see change.
This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility and assesses treatment dose. Twenty-four young women and girls with eating disorder (ED) symptoms are randomized to baseline duration between 2-6 weeks. Participants complete up to eight 20-30 minute sessions of a multimedia application using their mobile phone. Psychological flexibility is measured repeatedly using a multi-level, multi-dimensional assessment strategy of self-report and 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Intervention consists of eight 20-30 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.
Duke University
Durham, North Carolina, United States
Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility.
Time frame: Baseline, 6-8 weeks and 12 weeks
High Frequency Heart Rate Variability (HF-HRV)
Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress. Indexed by HF Power ms\^2 (Induction-Rest).
Time frame: Baseline, 6-8 weeks, and 12 weeks
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli).
Time frame: Baseline, 6-8 weeks, and 12 weeks
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility.
Time frame: Baseline, 6-8 weeks, 12 weeks
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
Number of fixations on body and food related images presented during HF-HRV task.
Time frame: Baseline, 6-8 weeks, 12 weeks
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