Randomized Controlled Trial of Project Body Neutrality

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172452
• Other study ID #: STU00220039
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: June 7, 2024

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: Jessica L Schleider, PhD
• Phone: (917) 439-1872
• Email: jessica.schleider[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 7, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Image
• Depression
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Project Body Neutrality SSI
Online, 30-minute self-guided intervention for youth ages 13-17
• Supportive Therapy SSI
Online, 30-minute self-guided activity for youth ages 13-17

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View Citation

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

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. — View 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. — View 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. — View 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. — View 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.

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. — View 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.

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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Image Acceptance and Action Questionnaire (BI-AAQ; Sandoz et al., 2013)	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.	Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
Other	Comprehensive Inventory of Mindfulness Experiences for Adolescents - Accepting with Nonjudgmental Orientation Subscale (CHIME-A; Johnson et al., 2017)	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.	Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
Other	Muscle Dysmorphic Disorder Inventory (MDDI; Hildebrandt et al., 2004)	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.	Pre-Intervention to 3-month follow-up
Other	Program Feedback Scale (PFS; Schleider et al., 2019)	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.	Immediately Post-Intervention
Other	Treatment seeking questions	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?"	3-month follow-up
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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