FlexED: A Digital, Gamified Early Intervention for Eating Disorders

January 29, 2024 updated by: Duke University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
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.
Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
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.
Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

University of Cyprus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00111571

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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