Body Image, Eating Disorders
Conditions
Keywords
Eating Disorders, Body Image Flexibility, Acceptance and Commitment Therapy, Psychological Flexibility, Online, Early Intervention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFlexED
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.
Sponsors
Duke University
University of Cyprus
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 identified 15-25 years old * Weight Concerns Scale score of \>47 * Eating disorder behaviors with onset at current level \<3 years
Exclusion criteria
* Currently meet diagnostic criteria for anorexia or bulimia nervosa * Psychosis, substance use disorder or current suicidal ideation or self-harm. * Start or change in psychiatric medications within the past month. * NonEnglish Speaking. * Presents with other specified feeding or eating disorder (OSFED) that does not includes weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5) | Baseline, 6-8 weeks and 12 weeks | 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. |
| High Frequency Heart Rate Variability (HF-HRV) | Baseline, 6-8 weeks, and 12 weeks | 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). |
| Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli | Baseline, 6-8 weeks, and 12 weeks | 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). |
| CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy) | Baseline, 6-8 weeks, 12 weeks | 10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility. |
| Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli | Baseline, 6-8 weeks, 12 weeks | Number of fixations on body and food related images presented during HF-HRV task. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited using electronic health record messaging. Messages were sent to females between the ages of 15-25 years old in the Duke Health System. The study was also posted online, including to a Duke student list.
Pre-assignment details
Aim 1 Parts 1-3 participants were not considered enrolled in this clinical trial. Ten participants were enrolled in the study, then did not pass the second stage of screening (leaving N=24 assigned to treatment). The last four participants assigned to treatment were assigned to the condensed schedule, rather than randomized to one of the three trial arms/baseline durations.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 20.3 years STANDARD_DEVIATION 4.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 | 0 / 7 | 0 / 4 |
| other Total, other adverse events | 0 / 6 | 0 / 7 | 0 / 7 | 0 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 | 0 / 7 | 0 / 4 |
Outcome results
None listed