DepressionNCT06172452
Randomized Controlled Trial of Project Body Neutrality
A study testing Project Body Neutrality SSI and Supportive Therapy SSI in people with Depression and Eating Disorders, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression, Eating Disorders, Body Image
- What is being tested?
- Project Body Neutrality SSI and Supportive Therapy SSI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2023to 18 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing a Single-Session Online Body Image and Mood Program for Sexual and Gender Minority (SGM) Adolescents
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
- Being tested
- Project Body Neutrality SSI, Supportive Therapy SSI
- Medical subject headings
- Depression, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project Body Neutrality SSIBehavioural
Online, 30-minute self-guided intervention for youth ages 13-17
Supportive Therapy SSIBehavioural
Online, 30-minute self-guided activity for youth ages 13-17
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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/. Receives: Behavioral: Supportive Therapy SSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Pre-Intervention to 3-month follow-up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start7 Dec 2023
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the intervention condition or the supportive therapy control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Schleider, Northwestern University
- Investigators
- Jessica L Schleider, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172452
- Sponsor's protocol ID
- STU00220039
- Status last verified
- Feb 2024
- First submitted
- 7 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28822275Cash 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.
PubMed 16864251Fairburn 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.
PubMed 36516727Hildebrandt 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.
PubMed 18089149Johnson 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.
PubMed 27254018Kroenke 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.
PubMed 14583691Messer 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.
PubMed 23756722Sandoz 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.
PubMed 31290406Snyder 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.
PubMed 8636885Smith 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.
PubMed 40578276
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Single-Session Online Body Image and Mood Program for Sexual and Gender Minority (SGM) Adolescents
- ClinicalTrials.gov ID
- NCT06172452
- Acronym / sponsor ID
- STU00220039
- Conditions
- Depression, Eating Disorders, Body Image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the intervention condition or the supportive therapy control.
| Arm | Type | Receives |
|---|---|---|
| Project Body Neutrality SSI | Experimental | Behavioral: Project Body Neutrality SSIProject 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. |
| Supportive Therapy SSI | Placebo comparator | Behavioral: Supportive Therapy SSIThe 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/. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project Body Neutrality SSIOnline, 30-minute self-guided intervention for youth ages 13-17 | Behavioural | Project Body Neutrality SSI |
| Supportive Therapy SSIOnline, 30-minute self-guided activity for youth ages 13-17 | Behavioural | Supportive Therapy SSI |
Primary outcome
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.
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).
4 secondary outcomes
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
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
Functionality Appreciation Scale (FAS; Alleva et al., 2017)
Time frame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
Body Image States Scale (BISS; Cash et al., 2002)
Time frame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 28822275Alleva 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.
- Background: PubMed 16864251Cash 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.
- BackgroundFairburn CG, Beglin SJ. Eating disorder examination questionnaire. Cognitive Behavior Therapy and Eating Disorders. 2008; 309: 313.
- Background: PubMed 36516727Habashy 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.
- Background: PubMed 18089149Hildebrandt 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.
- Background: PubMed 27254018Johnson 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.
- Background: PubMed 14583691Kroenke 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.
- BackgroundMesser 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: PubMed 23756722Perczel 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.
- BackgroundSandoz 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: PubMed 31290406Schleider 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.
- Background: PubMed 8636885Snyder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica L Schleider, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Body Neutrality SSI and Supportive Therapy SSI in people with Depression and Eating Disorders, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06172452, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.