- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05559944
Brief Writing Programs for Sexual Minority Young Adults in Alabama
January 29, 2024 updated by: Tiffany Brown, Auburn University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
A general list of the types of stressors and contexts commonly described will be provided to participants, given that meta-analytic research supports that providing examples enhances the efficacy of 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.
|
|
Experimental: Self-Affirmation
Participants will respond to 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.
|
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.
|
|
Placebo Comparator: Control
Consistent with prior research participants will write about their routine daily activities since waking up for 20 minutes each day, sans emotional content.
|
Consistent with prior research participants will write about their routine daily activities since waking up for 20 minutes each day, sans emotional content.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Image
Time Frame: changes from baseline through 1-month follow-up
|
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
|
|
Eating Disorder Symptoms
Time Frame: changes from baseline through 1-month follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Internalization of Appearance Ideals and Pressures
Time Frame: changes from baseline through 1-month follow-up
|
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
|
|
Negative Affect
Time Frame: changes from baseline through 1-month follow-up
|
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
|
|
Interpersonal Emotion Regulation
Time Frame: changes from baseline through 1-month follow-up
|
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
|
|
Health-related quality of life
Time Frame: changes from baseline through 1-month follow-up
|
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
|
|
Social Self-Esteem
Time Frame: changes from baseline through 1-month follow-up
|
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
|
|
Self-Stigma of Seeking Help
Time Frame: changes from baseline through 1-month follow-up
|
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
|
|
Substance Use
Time Frame: changes from baseline through 1-month follow-up
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coping Self-Efficacy
Time Frame: Baseline
|
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
|
|
Discrimination
Time Frame: Baseline
|
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
|
|
Internalized Stigma
Time Frame: Baseline
|
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
|
|
Sexual Orientation Concealment
Time Frame: Baseline
|
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
|
|
Rejection Sensitivity
Time Frame: Baseline
|
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
|
|
Community Involvement
Time Frame: Baseline
|
Items from the Social Justice Sexuality Survey include 6 items of LGBTQ community involvement (range 6-36, higher scores indicate greater community involvement)
|
Baseline
|
|
Intraminority Stress
Time Frame: Baseline
|
Abbreviated Intraminority Stress Scale; Assesses stressors within the gay community (8 items, range 8-40, higher scores indicate greater perception of community stress)
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jordan Merriweather, Auburn University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
September 19, 2022
First Submitted That Met QC Criteria
September 26, 2022
First Posted (Actual)
September 29, 2022
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- #22-317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be maintained for 5 years following the close of the study.
Those interested in learning more about the data can contact the Principal Investigator (tab0110@auburn.edu)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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