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Trial record 1 of 1 for:    NCT05609409
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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
Sponsor:
Collaborator:
University of Cyprus
Information provided by (Responsible Party):
Duke University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Rhonda M Merwin, PhD 919-681-7231 rhonda.merwin@duke.edu
Contact: Dorothy Mayo dorothy.mayo@duke.edu

Sponsors and Collaborators
Duke University
University of Cyprus
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT05609409    
Other Study ID Numbers: Pro00111571
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Eating Disorders
Body Image Flexibility
Acceptance and Commitment Therapy
 Psychological Flexibility
Online
Early Intervention
Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders