FlexED: A Digital, Gamified Early Intervention for Eating Disorders

Sponsor

Duke University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05609409

Collaborator

University of Cyprus (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this multiple baseline experiment is to test the effect of a digital, gamified early intervention for eating disorders on body image flexibility and determine treatment dose. Twenty-four young women and girls (between the ages of 15-25) with eating disorder (ED) symptoms will be randomized to different baseline durations (varying between 2-6 weeks). Participants will complete eight 20-30 minute sessions of a multimedia application over 10 weeks using their home computer or mobile device. Body Image Flexibility (BIF) will be measured repeatedly using a multimodal assessment strategy (behavior, physiological and self-report) during baseline and treatment phases. The investigators will estimate the effect of the intervention on BIF and examine when change occurs and plateaus (with no discernable benefit for additional sessions) to determine treatment dose.

Condition or Disease	Intervention/Treatment	Phase
Eating Disorders Body Image	Behavioral: FlexED	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

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.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)

Primary Purpose:

Treatment

Official Title:

FlexED: A Digital, Gamified Early Intervention for Eating Disorders

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Digital Intervention Eight 20-30 minute sessions of an online, multimedia application	Behavioral: FlexED 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.

Arm

Intervention/Treatment

Experimental: Digital Intervention

Eight 20-30 minute sessions of an online, multimedia application

Behavioral: FlexED

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.

Outcome Measures

Primary Outcome Measures

Change in body image flexibility as indexed by the Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5) [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) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Female identified 15-25 years old
Weight Concerns Scale score of >47
Maladaptive weight control behaviors with onset <3 years

Exclusion Criteria:

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).