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FlexED: A Digital, Gamified Early Intervention for Eating Disorders

Primary Purpose

Eating Disorders, Body Image

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FlexED
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Eating Disorders, Body Image Flexibility, Acceptance and Commitment Therapy, Psychological Flexibility, Online, Early Intervention

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Digital Intervention

    Arm Description

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2022
    Last Updated
    May 11, 2023
    Sponsor
    Duke University
    Collaborators
    University of Cyprus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05609409
    Brief Title
    FlexED: A Digital, Gamified Early Intervention for Eating Disorders
    Official Title
    FlexED: A Digital, Gamified Early Intervention for Eating Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University
    Collaborators
    University of Cyprus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorders, Body Image
    Keywords
    Eating Disorders, Body Image Flexibility, Acceptance and Commitment Therapy, Psychological Flexibility, Online, Early Intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Digital Intervention
    Arm Type
    Experimental
    Arm Description
    Eight 20-30 minute sessions of an online, multimedia application
    Intervention Type
    Behavioral
    Intervention Name(s)
    FlexED
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in body image flexibility as indexed by the Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
    Description
    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.
    Time Frame
    Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
    Title
    Change in High Frequency Heart Rate Variability (HF-HRV)
    Description
    Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress.
    Time Frame
    Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
    Title
    Change in biased processing of body image stimuli relative to neutral stimuli
    Description
    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.
    Time Frame
    Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Female-identified
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rhonda M Merwin, PhD
    Phone
    919-681-7231
    Email
    rhonda.merwin@duke.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dorothy Mayo
    Email
    dorothy.mayo@duke.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    FlexED: A Digital, Gamified Early Intervention for Eating Disorders

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