Randomized Controlled Trial of Project Body Neutrality

NCT06172452 | Completed

• 1 other identifier: STU00220039
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Eating Disorders; Body Image

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  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)

  Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

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

  Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

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

  Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

Other Outcomes (5)

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

  Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

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

  Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

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

  Pre-Intervention to 3-month follow-up

Study Arms (2)

Project Body Neutrality SSI

EXPERIMENTAL

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

Supportive Therapy SSI

PLACEBO COMPARATOR

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

Interventions

Project Body Neutrality SSI BEHAVIORAL

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

Project Body Neutrality SSI

Supportive Therapy SSI BEHAVIORAL

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

Supportive Therapy SSI

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Identify as a sexual or gender minority individual per self-report
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (13)

• Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.

  PMID: 28822275 BACKGROUND

• Cash TF, Fleming EC, Alindogan J, Steadman L, Whitehead A. Beyond body image as a trait: the development and validation of the Body Image States Scale. Eat Disord. 2002 Summer;10(2):103-13. doi: 10.1080/10640260290081678.

  PMID: 16864251 BACKGROUND

• Fairburn CG, Beglin SJ. Eating disorder examination questionnaire. Cognitive Behavior Therapy and Eating Disorders. 2008; 309: 313.

  BACKGROUND

• Habashy J, Benning SD, Renn BN, Borgogna NC, Lawrence EM, Kraus SW. Psychometric properties of the eating disorder examination questionnaire: Factor analysis and measurement invariance by race/ethnicity and gender. Eat Behav. 2023 Jan;48:101696. doi: 10.1016/j.eatbeh.2022.101696. Epub 2022 Dec 7.

  PMID: 36516727 BACKGROUND

• Hildebrandt T, Langenbucher J, Schlundt DG. Muscularity concerns among men: development of attitudinal and perceptual measures. Body Image. 2004 May;1(2):169-81. doi: 10.1016/j.bodyim.2004.01.001.

  PMID: 18089149 BACKGROUND

• Johnson C, Burke C, Brinkman S, Wade T. Development and validation of a multifactor mindfulness scale in youth: The Comprehensive Inventory of Mindfulness Experiences-Adolescents (CHIME-A). Psychol Assess. 2017 Mar;29(3):264-281. doi: 10.1037/pas0000342. Epub 2016 Jun 2.

  PMID: 27254018 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.

  PMID: 14583691 BACKGROUND

• Messer SC, Angold A, Costello EJ, Loeber R, Van Kammen W, Stouthamer-Loeber M. Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents: Factor composition and structure across development. International Journal of Methods in Psychiatric Research. 1995; 5: 251-262.

  BACKGROUND

• Perczel Forintos D, Rozsa S, Pilling J, Kopp M. Proposal for a short version of the Beck Hopelessness Scale based on a national representative survey in Hungary. Community Ment Health J. 2013 Dec;49(6):822-30. doi: 10.1007/s10597-013-9619-1. Epub 2013 Jun 12.

  PMID: 23756722 BACKGROUND

• Sandoz EK, Wilson KG, Merwin RM, Kate Kellum, K. Assessment of body image flexibility: The Body Image-Acceptance and Action Questionnaire. Journal of Contextual Behavioral Science. 2013; 2(1): 39-48.

  BACKGROUND

• Schleider JL, Mullarkey MC, Weisz JR. Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13368. doi: 10.2196/13368.

  PMID: 31290406 BACKGROUND

• Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. J Pers Soc Psychol. 1996 Feb;70(2):321-35. doi: 10.1037//0022-3514.70.2.321.

  PMID: 8636885 BACKGROUND

• Smith AC, Ahuvia IL, Zapata JP, Cohen KA, Graham AK, Schleider JL. Randomized trial of a digital single-session intervention for body image and mood concerns among LGBTQ+ adolescents. Behav Res Ther. 2025 Oct;193:104809. doi: 10.1016/j.brat.2025.104809. Epub 2025 Jun 24.

  PMID: 40578276 DERIVED

MeSH Terms

Conditions

Depression; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jessica L Schleider, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to either the intervention condition or the supportive therapy control.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: December 7, 2023
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)