- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07218861
- Original Trial
You Belong and You Matter: An Exploration of Self-injurious Thoughts and Behaviors in LGTBQ+ Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Scope of the work
LGBTQ+ individuals are at a greater risk for self-injurious thoughts and behaviors than their cisgender, straight peers. Despite this known risk, there are no culturally sensitive empirically supported treatments for self-injurious thoughts and behaviors for LBGTQ+ individuals. Therefore, the aim of this study is to test the effectiveness of a brief LGBTQ+ affirming text message intervention in reducing self-injurious thoughts and behaviors among LGBTQ+ individuals. Participants will be 100 LGBTQ+ adults who report self-injurious thoughts and/or behaviors in the last month. All participants will do 14 days of ecological momentary assessment (brief assessments on their mobile device 5 times a day) pre-randomization. After this period, half the participants will receive 2 brief affirming messages a day (morning and afternoon) for 14 days, and half of the participants will receive no messages for 14 days. The text messages will be designed to communicate belonging and importance for LGBTQ+ individuals in society (e.g., "There are over 9,000,000 LGBTQ+ people in the United States. You are not alone". Then all participants will complete another 14 days of ecological momentary assessment. During the assessment periods, participants will report on experiences of discrimination, belongingness, perceived burdensome, and self-injurious thoughts. We predict that participants in the mobile health condition will have a significant decrease in self-injurious thoughts and behaviors from pre- to post-intervention, whereas there will be no change in the control condition. We also predict that participants in the mobile health condition will lead to a significant decrease in thwarted belongingness and perceived burdensomeness. Finally, we predict that our intervention will help break the link between of experiences discrimination and self-injurious thoughts and behaviors by reducing feelings of thwarted belongingness and perceived burdensomeness in response to sexual and gender minority stress. If the effectiveness of our intervention is supported by the data, this intervention could be scaled up and be made available to the LGBTQ+ community broadly.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40208
- University of Louisville
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be 18 years or older b) have an LGBTQ+ identity (e.g., a sexual orientation other than exclusively straight and/or a gender identity other than exclusively cisgender) c) report at least one self-injurious thought (e.g., suicidal or nonsuicidal self-injury ideation), or behavior (nonsuicidal self-injury, suicide attempt) in the last month
Exclusion Criteria:
- Younger than 18, exclusivilty cisgender, heterosexual, no history of SITB in the last month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive Message Condition
Supportive messages
|
Participants received 28 supportive messages (2 per day) for 14 days
|
|
No Intervention: No Message Control
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-injurious thoughts and behavior
Time Frame: last two hours
|
self reported
|
last two hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ULouisville
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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