AzTrials
AzTrials

Expressive WritingNCT05559944

Brief Writing Programs for Sexual Minority Young Adults in Alabama

A study testing Expressive Writing and Self-Affirmation in people with Expressive Writing and Self-Affirmation, run by Auburn University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Expressive Writing, Self-Affirmation, Control
What is being tested?
Expressive Writing and Self-Affirmation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2024to Dec 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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])

Who cannot join

  • 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

About this study

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.

Being tested
Expressive Writing, Self-Affirmation, Control
Keywords
LGBTQIA+, Body Image, Alabama, Eating Disorders
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expressive WritingBehavioural

    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-AffirmationBehavioural

    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.

  • ControlBehavioural

    Consistent with prior research participants will write about their routine daily activities since waking up for 20 minutes each day, sans emotional content.

Study groups in NCT05559944
Study groupRoleWhat they receive
Expressive WritingExperimentalParticipants 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.
Receives: Behavioral: Expressive Writing
Self-AffirmationExperimentalParticipants 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.
Receives: Behavioral: Self-Affirmation
ControlPlacebo comparatorConsistent with prior research participants will write about their routine daily activities since waking up for 20 minutes each day, sans emotional content.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: changes from baseline through 1-month follow-up

  2. 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

    Measured: changes from baseline through 1-month follow-up

Secondary outcomes (7)

  1. 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

    Measured: changes from baseline through 1-month follow-up

  2. 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

    Measured: changes from baseline through 1-month follow-up

  3. 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.

    Measured: changes from baseline through 1-month follow-up

  4. 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.

    Measured: changes from baseline through 1-month follow-up

  5. 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.

    Measured: changes from baseline through 1-month follow-up

  6. 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.

    Measured: changes from baseline through 1-month follow-up

  7. 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.

    Measured: changes from baseline through 1-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study startDec 2024 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: Study never started as changes to the study structure were determined by the community advisory board overseeing the project prior to study start.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05559944
Sponsor's protocol ID
#22-317
Status last verified
Jan 2024
First submitted
19 Sep 2022
Last updated
30 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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)

Questions about this trial

What is this clinical trial studying?

A study testing Expressive Writing and Self-Affirmation in people with Expressive Writing and Self-Affirmation, run by Auburn University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Image (time frame: changes from baseline through 1-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05559944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in