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Behavioral Intervention

Project Body Neutrality SSI for Depression

N/A

Recruiting

Led By Jessica L Schleider, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-month follow-up

Awards & highlights

Study Summary

This trial will test a one-time therapy session for teenagers who are part of the LGBTQ+ community to see if it helps reduce symptoms of depression and eating disorders. Participants will be randomly assigned to either the

Who is the study for?

This trial is for SGM adolescents aged 13-17 in the U.S. who have body image concerns and signs of depression. They must understand consent, speak English, and not have been in a Project Body Neutrality study before.Check my eligibility

What is being tested?

The trial compares two single-session interventions for reducing depression and eating disorder risks: 'Project Body Neutrality' versus supportive therapy. Participants are randomly assigned to one group and followed up with questionnaires over three months.See study design

What are the potential side effects?

Since this is a psychological intervention rather than medication, traditional side effects aren't expected; however, discussing sensitive topics may cause temporary emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

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

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

+1 more

Other outcome measures

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

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

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

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Project Body Neutrality SSIExperimental Treatment1 Intervention

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.

Group II: Supportive Therapy SSIPlacebo Group1 Intervention

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/.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

916,837 Total Patients Enrolled

66 Trials studying Depression

27,966 Patients Enrolled for Depression

Jessica L Schleider, PhDPrincipal InvestigatorNorthwestern University

7 Previous Clinical Trials

5,787 Total Patients Enrolled

5 Trials studying Depression

5,727 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which specific criteria must individuals meet in order to qualify for participation in this research?

"Individuals aged between 13 and 17 who are grappling with eating disorders may be eligible for enrollment in this study. A total of 250 participants will be accepted into the trial."

Answered by AI

Are there ongoing efforts to actively enroll participants in this trial?

"Affirmative. Details on clinicaltrials.gov indicate that this trial is actively pursuing participants. The posting date was 12/7/2023, with the latest update made on 2/26/2024. Recruitment aims to enroll 250 patients at a single designated site."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"Affirmative. The details on clinicaltrials.gov imply that this research endeavor is actively seeking volunteers. The initial posting date was 12/7/2023, with the most recent edit made on 2/26/2024. A total of 250 participants are sought at a single site for inclusion in the study."

Answered by AI

Are participants aged 55 and older eligible for inclusion in this research study?

"Individuals aged between 13 and 17 are eligible to participate in this scientific investigation. Notably, there are a total of 260 clinical trials targeting individuals under the age of majority and an additional 954 studies focusing on patients over the age of retirement."

Answered by AI

What is the main objective of this medical study?

"The main focus of this research will be on the Eating disorder Examination Questionnaire - 10 item, 3 factor version (EDE-Q; Fairburn & Beglin, 2008; Habashy et al., 2023), which will be assessed from pre-intervention to a follow-up period of three months. Secondary measurements encompass the Beck Hopelessness Scale - 4 item version (BHS; Perczel Forintos et al., 2013) that gauges feelings of hopelessness on a scale ranging from absolutely disagree to absolutely agree with scores between 0 and12 indicating varying levels of despair. Additionally, participants"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Controlled Trial of Project Body Neutrality

Jessica Schleider 2023. "Randomized Controlled Trial of Project Body Neutrality". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06172452.

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