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Completed

NCT Number: NCT06172452

Randomized Controlled Trial of Project Body Neutrality

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project Body Neutrality SSI

Behavioral

Online, 30-minute self-guided intervention for youth ages 13-17

Supportive Therapy SSI

Behavioral

Online, 30-minute self-guided activity for youth ages 13-17

Primary outcomes

  1. Eating Disorder Examination Questionnaire - 10 item, 3 factor version (EDE-Q; Fairburn & Beglin, 2008; Habashy et al., 2023)

    Time frame: Pre-Intervention to 3-month follow-up

    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.

  2. Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995)

    Time frame: Pre-Intervention to 3-month follow-up

    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).

Secondary outcomes

  1. Beck Hopelessness Scale - 4 item version (BHS; Perczel Forintos et al., 2013)

    Time frame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

    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.

  2. State Hope Scale - 3 item Pathways subscale (SHS; Snyder et al., 1996)

    Time frame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

    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.

  3. Functionality Appreciation Scale (FAS; Alleva et al., 2017)

    Time frame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

    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.

  4. Body Image States Scale (BISS; Cash et al., 2002)

    Time frame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

    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.

Other outcomes

  1. Body Image Acceptance and Action Questionnaire (BI-AAQ; Sandoz et al., 2013)

    Time frame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

    Asks respondents to rate twelve items from 1 (Never True) to 7 (Always True). Total scores range from 12 to 84, with higher scores indicating greater body image flexibility.

  2. Comprehensive Inventory of Mindfulness Experiences for Adolescents - Accepting with Nonjudgmental Orientation Subscale (CHIME-A; Johnson et al., 2017)

    Time frame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

    Asks respondents to rate three items from 1 (Almost Never) to 6 (Almost Always). Total scores range from 3 to 18 with higher scores indicating greater nonjudgmental acceptance. We adapted the items of this subscale to ask specifically about nonjudgmental acceptance of one's physical appearance.

  3. Muscle Dysmorphic Disorder Inventory (MDDI; Hildebrandt et al., 2004)

    Time frame: Pre-Intervention to 3-month follow-up

    Asks respondents to rate thirteen items from 1 (Never) to 5 (Always). Total scores range from 13 to 65 with higher scores reflecting a greater severity of muscle dysphoria symptoms.

  4. Program Feedback Scale (PFS; Schleider et al., 2019)

    Time frame: Immediately Post-Intervention

    Asks respondents to rate seven statements regarding intervention acceptability and feasibility; it also includes open-ended items that invite respondents to share what they liked and/or would change about the intervention. The seven statements are rated from 1 (Really Disagree) to 5 (Really Agree). Total score ranges from 5 to 35, with higher scores indicating a more positive evaluation.

  5. Treatment seeking questions

    Time frame: 3-month follow-up

    Respondents are asked two questions about mental health treatment seeking in the past three months: "In the past 3 months (since completing the first survey for this study), did you seek out any new support for depression or mood problems?" and "In the past 3 months (since completing the first survey for this study), did you seek out any new support for an eating disorder or body image problems?"

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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