Control Clinical Trial
Official title:
Brief Writing Programs for Sexual Minority Young Adults in Alabama
NCT number | NCT05559944 |
Other study ID # | #22-317 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2024 |
Est. completion date | December 2026 |
Verified date | January 2024 |
Source | Auburn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Auburn University |
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 |
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