Randomized Controlled Trial of Project Body Neutrality

Study Overview
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Brief Summary
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This study tests a single-session intervention (SSI) targeting risk factors for depression and eating disorders among sexual and gender minority (SGM) adolescents. Youth ages 13-17 who identify as sexual or gender minorities will be randomized to the intervention condition (Project Body Neutrality SSI) or a control (supportive therapy SSI). Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project Body Neutrality leads to reductions in depression and eating disorder symptoms compared to the control.

Official Title
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Testing a Single-Session Online Body Image and Mood Program for Sexual and Gender Minority (SGM) Adolescents

Conditions
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Depression, Eating Disorders, Body Image

Intervention / Treatment
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* Behavioral: Project Body Neutrality SSI
* Behavioral: Supportive Therapy SSI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identify as a sexual or gender minority individual per self-report 13-17 years old at the time of enrollment English proficiency per self-report Report having body image concerns per self-report Score of ≥ 2 on the Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003), - indicating elevated depressive symptoms Did not participate in a past study involving Project Body Neutrality per self-report Residing within the United States per IP address Passes comprehension of consent language assessment Exclusion Criteria: Fail to meet the above-listed inclusion criteria Exit the study prior to condition randomization Failure to pass the data integrity measures Duplicate responses from the same individual in baseline or follow-up surveys

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to either the intervention condition or the supportive therapy control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project Body Neutrality SSI<br>Project Body Neutrality is a digital, self-guided SSI that teaches adolescents about body neutrality. It contains self-reflection exercises, vignettes from fictional peers, and psychoeducation that support users in understanding why body positivity may be a difficult mindset for some individuals to obtain; additional self-reflection exercises and vignettes that present body neutrality as a well-rounded alternative to body positivity; exercises that culminate in a user-generated list of activities that their body allows them to enjoy as well as statements they can use to counter negative thoughts about their body; writing prompts where users provide advice based on body neutrality principles to fictional peers struggling with their body image; and an opportunity to contribute their advice or reflections anonymously to a lab-run social media campaign as a form of body neutrality advocacy. See all materials for this intervention here: https://osf.io/7qtuj. | Behavioral: Project Body Neutrality SSI<br>* Online, 30-minute self-guided intervention for youth ages 13-17<br>|
| Placebo Comparator: Supportive Therapy SSI<br>The Sharing Feelings SSI is a digital, self-guided SSI that is structurally similar to Project Body Neutrality, but it is designed to mimic supportive therapy (ST). The goals of the ST intervention are to encourage participants to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. The ST-SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program, reading and writing exercises, and vignettes from fictional peers. See all materials for this intervention here: https://osf.io/u4axs/. | Behavioral: Supportive Therapy SSI<br>* Online, 30-minute self-guided activity for youth ages 13-17<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Disorder Examination Questionnaire - 10 item, 3 factor version (EDE-Q; Fairburn & Beglin, 2008; Habashy et al., 2023) | A 10-item questionnaire designed to assess the range and severity of features associated with a diagnosis of eating disorder. The original measure's factor structure has failed to replicate across many samples, especially for diverse populations. This version has achieved strict invariance by gender and race/ethnicity. Higher global scores indicate greater eating disorder severity (primary outcome). Outcomes for the three subscales (Dietary Restaurant, Preoccupation with Eating Concern, and Shape/Weight Overvaluation) will also be reported. Each item is on a 0 to 6 scale and the scores are computed as means. | Pre-Intervention to 3-month follow-up | 
| Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995) | A 13-item questionnaire designed to assess depressive symptoms in youth. Total scores range from 0 to 26, with higher scores indicating greater depression severity (primary outcome). | Pre-Intervention to 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Hopelessness Scale - 4 item version (BHS; Perczel Forintos et al., 2013) | Asks respondents to rate four statements reflecting their sense of hopelessness from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Total scores range from 0 to 12, with higher scores indicating greater levels of hopelessness. | Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up | 
| State Hope Scale - 3 item Pathways subscale (SHS; Snyder et al., 1996) | Asks respondents to rate three statements from 1 (Definitely False) to 8 (Definitely True). Total score ranges from 3 to 24, with higher scores reflecting greater perceived ability to identify goal-oriented routes. | Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up | 
| Functionality Appreciation Scale (FAS; Alleva et al., 2017) | Asks respondents to rate seven statements from 1 (Strongly Disagree) to 5 (Strongly Agree). Total scores range from 7 to 35, where higher scores indicate greater appreciation for body functionality. | Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up | 
| Body Image States Scale (BISS; Cash et al., 2002) | Asks respondents to rate six items from 1 (poor body image state) to 9 (favorable body image state). Total scores range from 6 to 54, where higher scores indicate a more favorable body image state. | Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up |