FlexED: A Digital, Gamified Early Intervention for Eating Disorders
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|ClinicalTrials.gov Identifier: NCT05609409|
Recruitment Status : Not yet recruiting
First Posted : November 8, 2022
Last Update Posted : January 19, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Eating Disorders Body Image||Behavioral: FlexED||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group 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.
|Masking:||None (Open Label)|
|Official Title:||FlexED: A Digital, Gamified Early Intervention for Eating Disorders|
|Estimated Study Start Date :||April 2023|
|Estimated Primary Completion Date :||August 2024|
|Estimated Study Completion Date :||August 2024|
Experimental: Digital Intervention
Eight 20-30 minute sessions of an online, multimedia application
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.
- Change in body image flexibility as indexed by the Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5) [ Time Frame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 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.
- Change in High Frequency Heart Rate Variability (HF-HRV) [ Time Frame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks ]Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress.
- Change in biased processing of body image stimuli relative to neutral stimuli [ Time Frame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks ]Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by changes in reaction time and fewer errors.
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|Ages Eligible for Study:||15 Years to 25 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Female-identified|
|Accepts Healthy Volunteers:||No|
- Female identified 15-25 years old
- Weight Concerns Scale score of >47
- Maladaptive weight control behaviors with onset <3 years
- Currently meets full diagnostic criteria anorexia or bulimia nervosa or has in the past.
- 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 have weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05609409
|Contact: Rhonda M Merwin, PhDfirstname.lastname@example.org|
|Contact: Dorothy Mayoemail@example.com|
|Responsible Party:||Duke University|
|Other Study ID Numbers:||
|First Posted:||November 8, 2022 Key Record Dates|
|Last Update Posted:||January 19, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Body Image Flexibility
Acceptance and Commitment Therapy
Feeding and Eating Disorders