Brief Writing Programs for Sexual Minority Young Adults in Alabama

Control Clinical Trial

Official title:

Brief Writing Programs for Sexual Minority Young Adults in Alabama

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05559944
• Other study ID #: #22-317
• Status: Withdrawn
• Phase: N/A
• Start date: December 2024
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sexual minority (SM; e.g., gay, lesbian, bisexual, pansexual, queer) young adults are at elevated risk for eating disorders (EDs). Researchers have used minority stress theory to understand how increased risk is due, in part, to stigma and discrimination from being part of a marginalized group. Despite this glaring inequity, limited programs exist to prevent EDs in SM populations. Critically, many SM young people live in rural regions with high anti-LGBTQ+ stigma and limited access to SM-specific resources. The proposed project will address this gap by adapting and evaluating two brief online interventions to reduce ED risk. N = 120 SM young adults in rural regions of Alabama with high LGBTQ+ stigma and low SM-specific resources will be randomized into one three brief online writing interventions: 1) expressive writing (n = 40), 2) self-affirmation (n = 40), or 3) control (n = 40). Participants will complete assessments pre-intervention, post-intervention, and 1-month post-intervention. Aim 1 will assess intervention feasibility and acceptability. Aim 2 will compare the brief online writing interventions to control in improving body image and ED symptoms. Finally, an exploratory aim will examine posited intervention mechanisms and whether the level of SM stigma and discrimination participants experience pre-intervention impacts intervention efficacy. This research will help support and benefit underserved SM young adults by filling a critical need for brief, scalable interventions that can be delivered online to help reduce ED risk. Data from this project will serve as pilot data for a subsequent R-series grant application from NIH.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• ages 18-30
• identify as SM (gay, lesbian, bisexual, pansexual, or queer)
• endorse body dissatisfaction
• currently living in one of the following AL counties: Lee, Dallas, Lowndes, Autauga, Coosa, Elmore, Tallapoosa, Macon, or Russell
• have internet access (either via computer/tablet, mobile phone, or community center[e.g., library])

Exclusion Criteria:

• meet criteria for an ED, based on self-report screener
• non-English speaking
• Lack of internet access
• Not living in one of the following AL counties: Lee, Dallas, Lowndes, Autauga, Coosa, Elmore, Tallapoosa, Macon, or Russell
• Younger than 18, older than 30

Related Conditions & MeSH terms

• Control
• Expressive Writing

Intervention

Behavioral:
• Expressive Writing
Participants will be asked to write about the biggest body image or eating-related stressor they have experienced as a member of the LGBTQ+ community.
• Self-Affirmation
Participants will receive one new vignette per day describing a SM young adult experiencing severe body image stress in Alabama. Participants will be asked to write to this person and provide advice based on their own experience as a SM young adult. Vignettes will be identical across participants; however, they will be matched to participants' sexual identity, gender identity, and race/ethnicity.
• Control
Consistent with prior research participants will write about their routine daily activities since waking up for 20 minutes each day, sans emotional content.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Coping Self-Efficacy	Coping Self Efficacy Scale (CSES); Assesses sexual minority(SM)-stress coping self efficacy, as adapted for address SM stress in prior research (13 items, 11-point scale, range 0-130, higher scores indicate greater SM-stress coping self-efficacy).	Baseline
Other	Discrimination	Heterosexist Harassment, Rejection, and Discrimination Scale; Measure assesses experiences with victimization and rejection related to SGM identity (14 items, scores range from 14-84, with higher scores reflecting greater experiences with discrimination)	Baseline
Other	Internalized Stigma	Internalized Homophobia Scale (IHP); Assess internalization of negative attitudes toward one's sexual identity (9 items, scores range from 5-45, higher scores indicate greater internalized stigma)	Baseline
Other	Sexual Orientation Concealment	Sexual Orientation Concealment Scale (SOCS); Assess the degree to which one intentionally conceals their sexual identity (6 items, scores range from 6-30, higher scores indicate greater concealment)	Baseline
Other	Rejection Sensitivity	Sexual Minority Women (or Gay-Related) Rejection Sensitivity; Assesses sensitivity towards rejection due to sexual identity (14-16 items, ranges 1-36, higher scores indicate greater rejection sensitivity)	Baseline
Other	Community Involvement	Items from the Social Justice Sexuality Survey include 6 items of LGBTQ community involvement (range 6-36, higher scores indicate greater community involvement)	Baseline
Other	Intraminority Stress	Abbreviated Intraminority Stress Scale; Assesses stressors within the gay community (8 items, range 8-40, higher scores indicate greater perception of community stress)	Baseline
Primary	Body Image	Body Image States Scale (BISS); 7-item self-report measure about satisfaction with overall appearance. Scores range from 1-9, with higher scores reflecting more positive body image	changes from baseline through 1-month follow-up
Primary	Eating Disorder Symptoms	Eating Pathology Symptom Inventory (EPSI); 45-item measure that assesses 8 domains of eating disorder pathology, scores range from 0-32, with higher scores indicating greater pathology	changes from baseline through 1-month follow-up
Secondary	Internalization of Appearance Ideals and Pressures	Sociocultural Attitudes Towards Appearance Scale-4 (SATAQ-4); 22-item measure of internalization of appearance ideals and pressures. Scores range from 4-25, with higher scores indicating greater appearance internalization	changes from baseline through 1-month follow-up
Secondary	Negative Affect	Depression, Anxiety, and Stress Scale (DASS-21); 21 item measure used to assess depression, anxiety, and nonspecific physiological arousal which load onto a higher order factor of psychological distress/negative affect. Scores range from 0-63, with higher scores indicating greater negative affect	changes from baseline through 1-month follow-up
Secondary	Interpersonal Emotion Regulation	Difficulties in Interpersonal Regulation of Emotion (DIRE); 24-item measures of maladaptive interpersonal emotional regulation. Scores range from 3-30 and higher scores indicate greater pathology.	changes from baseline through 1-month follow-up
Secondary	Health-related quality of life	World Health Organization Quality of Life- (WHO-BREF); 26-item self-report measure for physical and psychological social relationships and environmental health. Scores range from 4-20; higher scores indicate a better quality of life.	changes from baseline through 1-month follow-up
Secondary	Social Self-Esteem	Social Self-Esteem Scale (SSES); Measures confidence and self-esteem in social situations across 9 items. Scores range from 9-54, with higher scores indicating grater social self-esteem.	changes from baseline through 1-month follow-up
Secondary	Self-Stigma of Seeking Help	Self-Stigma of Seeking Help (SSOSH); Stigma surrounding seeking help for psychological concerns. Scores range from 10-50, with higher scores indicating greater stigma.	changes from baseline through 1-month follow-up
Secondary	Substance Use	Alcohol, Smoking, and Substance Involvement Screening (ASSIST); Examines alcohol and substance use patterns. Scores range from 0-39 and higher scores reflect greater substance use problems.	changes from baseline through 1-month follow-up

External Links

•   Contact Page for Study Enrollment and Information