Clinical trial NCT06172452: Randomized Controlled Trial of Project Body Neutrality
Official title: Testing a Single-Session Online Body Image and Mood Program for Sexual and Gender Minority (SGM) Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Eating Disorders
Body Image
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 220
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the intervention condition or the supportive therapy control.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Eating Disorder Examination Questionnaire - 10 item, 3 factor version (EDE-Q; Fairburn & Beglin, 2008; Habashy et al., 2023)
timeFrame: Pre-Intervention to 3-month follow-up
measure: Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995)
timeFrame: Pre-Intervention to 3-month follow-up
Secondary outcomes:
measure: Beck Hopelessness Scale - 4 item version (BHS; Perczel Forintos et al., 2013)
timeFrame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
measure: State Hope Scale - 3 item Pathways subscale (SHS; Snyder et al., 1996)
timeFrame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
measure: Functionality Appreciation Scale (FAS; Alleva et al., 2017)
timeFrame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
measure: Body Image States Scale (BISS; Cash et al., 2002)
timeFrame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
Other outcomes:
measure: Body Image Acceptance and Action Questionnaire (BI-AAQ; Sandoz et al., 2013)
timeFrame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
measure: Comprehensive Inventory of Mindfulness Experiences for Adolescents - Accepting with Nonjudgmental Orientation Subscale (CHIME-A; Johnson et al., 2017)
timeFrame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
measure: Muscle Dysmorphic Disorder Inventory (MDDI; Hildebrandt et al., 2004)
timeFrame: Pre-Intervention to 3-month follow-up
measure: Program Feedback Scale (PFS; Schleider et al., 2019)
timeFrame: Immediately Post-Intervention
measure: Treatment seeking questions
timeFrame: 3-month follow-up
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jessica L Schleider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Fairburn CG, Beglin SJ. Eating disorder examination questionnaire. Cognitive Behavior Therapy and Eating Disorders. 2008; 309: 313.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.