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Control clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT05559944 Withdrawn - Control Clinical Trials

Brief Writing Programs for Sexual Minority Young Adults in Alabama

Start date: December 2024
Phase: N/A
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.