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| Name | Class |
|---|---|
| University of Cyprus | OTHER |
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The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old.
Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments.
Researchers will examine the impact of the intervention on participants ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye gaze, and reaction time to body-image related words and images, and test how long it takes to see change.
This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility and assesses treatment dose. Twenty-four young women and girls with eating disorder (ED) symptoms are randomized to baseline duration between 2-6 weeks. Participants complete up to eight 20-30 minute sessions of a multimedia application using their mobile phone. Psychological flexibility is measured repeatedly using a multi-level, multi-dimensional assessment strategy of self-report and lab-based tasks assessing flexibility in cognition, affect and attention with body-image related stimuli during the baseline and treatment phases to estimate treatment effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-Week Baseline Duration | Experimental | 2 weeks of assessment, then 8 weeks of intervention |
|
| 4-Week Baseline Duration | Experimental | 4 weeks of assessment, then 8 weeks of intervention |
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| 6-Week Baseline Duration | Experimental | 6 weeks of assessment, then 8 weeks of intervention |
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| Condensed schedule | Experimental | 2 weeks of assessment, then 4 weeks of intervention (sessions twice a week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlexED | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 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. | Baseline, 6-8 weeks and 12 weeks |
| 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. Indexed by HF Power ms^2 (Induction-Rest). | Baseline, 6-8 weeks, and 12 weeks |
| Change From Baseline 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 decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli). | Baseline, 6-8 weeks, and 12 weeks |
| CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy) | 10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility. | Baseline, 6-8 weeks, 12 weeks |
| Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli | Number of fixations on body and food related images presented during HF-HRV task. | Baseline, 6-8 weeks, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Female-identified
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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Aim 1 Parts 1-3 participants were not considered enrolled in this clinical trial. Ten participants were enrolled in the study, then did not pass the second stage of screening (leaving N=24 assigned to treatment). The last four participants assigned to treatment were assigned to the condensed schedule, rather than randomized to one of the three trial arms/baseline durations.
Participants were recruited using electronic health record messaging. Messages were sent to females between the ages of 15-25 years old in the Duke Health System. The study was also posted online, including to a Duke student list.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 Weeks No Intervention, Then 8 Weeks Intervention | Eight 20-30 minute sessions of an online, multimedia application 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. |
| FG001 | 4 Weeks No Intervention, Then 8 Weeks Intervention | Eight 20-30 minute sessions of an online, multimedia application 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. |
| FG002 | 6 Weeks No Intervention, Then 8 Weeks Intervention | Eight 20-30 minute sessions of an online, multimedia application 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. |
| FG003 | 2 Weeks No Intervention, Then 4 Weeks Intervention (Non-randomized Condensed Schedule) | Two sessions per week Eight 20-30 minute sessions of an online, multimedia application 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-8 Weeks (End-of-Treatment) |
|
| ||||||||||||||||||
| 12 Weeks (~1 Month Post) |
|
Aim 1 Parts 1-3 participants were involved in user-testing and are not considered enrolled in this clinical trial. Ten participants enrolled in the study did not pass second level screening, leaving 24 participants assigned to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 Weeks No Intervention, Then 8 Weeks Intervention | Eight 20-30 minute sessions of an online, multimedia application 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Eligible age range was 15-25 years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 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. | N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses. | Posted | Mean | Standard Deviation | Scale Score | Baseline, 6-8 weeks and 12 weeks |
|
Up to 14-18 weeks
Aim 1 Parts 1-3 participants were not considered enrolled in this clinical trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 Weeks No Intervention, Then 8 Weeks Intervention | Eight 20-30 minute sessions of an online, multimedia application 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rhonda M. Merwin, PhD | Duke University | (919) 681-7231 | rhonda.merwin@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2022 | Jun 9, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2024 | Mar 3, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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Noncurrent Multiple Baseline Experimental Design where subjects will serve as their own control.
Participants will be randomized to different baseline durations.
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|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 4 Weeks No Intervention, Then 8 Weeks Intervention | Eight 20-30 minute sessions of an online, multimedia application 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. |
| BG002 | 6 Weeks No Intervention, Then 8 Weeks Intervention | Eight 20-30 minute sessions of an online, multimedia application 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. |
| BG003 | 2 Weeks No Intervention, Then 4 Weeks Intervention (Condensed Schedule) | Two sessions per week Eight 20-30 minute sessions of an online, multimedia application 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. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Eligible participants were female. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | All participants were recruited at an academic medical center in the Southeast United States. | Count of Participants | Participants |
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|
|
| Primary | 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. Indexed by HF Power ms^2 (Induction-Rest). | N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses. | Posted | Mean | Standard Deviation | ms^2 | Baseline, 6-8 weeks, and 12 weeks |
|
|
|
|
| Primary | Change From Baseline 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 decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli). | N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses. | Posted | Mean | Standard Deviation | milliseconds | Baseline, 6-8 weeks, and 12 weeks |
|
|
|
|
| Primary | CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy) | 10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility. | N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses. | Posted | Mean | Standard Deviation | Scale Score | Baseline, 6-8 weeks, 12 weeks |
|
|
|
|
| Primary | Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli | Number of fixations on body and food related images presented during HF-HRV task. | N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses. | Posted | Mean | Standard Deviation | number of fixations | Baseline, 6-8 weeks, 12 weeks |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 4 Weeks No Intervention, Then 8 Weeks Intervention | Eight 20-30 minute sessions of an online, multimedia application 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. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | 6 Weeks No Intervention, Then 8 Weeks Intervention | Eight 20-30 minute sessions of an online, multimedia application 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. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | 2 Weeks No Intervention, Then 4 Weeks Intervention | Two sessions per week Eight 20-30 minute sessions of an online, multimedia application 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| Title | Measurements |
|---|---|
|
| Mean Difference (Net) |
| -0.31027 |
| 2-Sided |
| Other |
Piecewise linear modeling; standardized treatment effect |
| Title | Measurements |
|---|---|
|
| Mean Difference (Net) |
| -0.25408 |
| 2-Sided |
| Other |
Piecewise linear modeling; standardized treatment effect |
| Minimal dose estimate to achieve a small effect in weeks | Minimal dose in weeks | 1.64715 | 1-Sided | 90 | 3.51743 | Average bootstrapped minimal dose estimate to achieve a small effect in weeks and 90% upper confidence bound is based on data from Week 6-8 (End-of-Treatment). | Other | Bootstrapped piecewise linear modeling |
| Title | Measurements |
|---|---|
|
| Mean Difference (Net) |
| 0.46026 |
| 2-Sided |
| Other |
Piecewise linear modeling; standardized treatment effect |
| Minimal dose estimate to achieve a small effect in weeks | Minimal dose in weeks | 1.27129 | 1-Sided | 90 | 1.57143 | Average bootstrapped minimal dose estimate to achieve a small effect in weeks and 90% upper confidence bound is based on Week 6-8 (End-of-Treatment) data. | Other | Bootstrapped piecewise linear modeling |
| Title | Measurements |
|---|---|
|
| Mean Difference (Net) |
| -0.40269 |
| 2-Sided |
| Other |
Piecewise linear modeling; standardized treatment effect |
| Minimal dose estimate to achieve a small effect in weeks | Minimal dose in weeks | 1.71358 | 1-Sided | 90 | 6.0 | Average bootstrapped minimal dose estimate to achieve a small effect in weeks and 90% upper confidence bound is based on Week 6-8 (End-of-Treatment) data. | Other | Bootstrapped piecewise linear modeling |