Randomized Controlled Trial of Project Body Neutrality

Northwestern University

Status: Completed

Conditions: Eating Disorders; Body Image; Depression

Treatments: Behavioral: Project Body Neutrality SSI; Behavioral: Supportive Therapy SSI

Study type: Interventional

Funder types: Other

Identifiers

NCT06172452

STU00220039

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

220 participants in 2 patient groups, including a placebo group

Project Body Neutrality SSI

Experimental group

Description:

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.

Treatment:

Behavioral: Project Body Neutrality SSI

Supportive Therapy SSI

Placebo Comparator group

Description:

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/.

Treatment:

Behavioral: Supportive Therapy SSI