Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654414
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Project QUIT Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender Expansive Individuals
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Project QUIT Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender Expansive Individuals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Smoking remains the leading preventable cause of death in the United States and there are persistent and significant disparities in tobacco use among transgender and gender diverse TGD individuals Stigma discrimination gender dysphoria and other gender minority stressors likely contribute to these disparities and the increased burden of gender minority stress may also be driving higher prevalence rates of anxiety and depression both of which are more common among TGD individuals and among those who smoke relative to comparison samples This study will 1 explore the ways in which gender minority stressors and associated anxiety and depression compromise smoking cessation among TGD individuals identifying elements in an existing smoking cessation intervention that need to be adjusted to meet their unique needs 2 adapt an existing smoking cessation intervention for TGD individuals and 3 evaluate the feasibility and acceptability of the adapted intervention in a pilot randomized controlled trial
Detailed Description:
Despite the substantial decrease in the prevalence of smoking over the past 50 years there are persistent and significant disparities in tobacco use among transgender and gender diverse TGD individuals The prevalence of cigarette use in TGD individuals is 457 - 623 compared to 398 in cisgender individuals There are also disparities in e-cigarette use among TGD people relative to cisgender adults 265 vs 55 in transgender and cisgender men respectively Transgender individuals may be particularly vulnerable to the consequences of tobacco use as hormone therapy among those who smoke increases heart disease risk and smoking may hinder recovery from gender-affirming surgeries Stigma discrimination gender dysphoria and other gender minority stressors contribute to tobacco use disparities Enacted stigma and discrimination toward TGD individuals are common reported by over 75 of participants in some samples and experiencing stigma or discrimination increases the odds of current cigarette smoking e-cigarette usevaping and dual use among TGD people Gender dysphoria and gender minority stress may also lead to andor exacerbate disparities in anxiety and depression which are major impediments to smoking cessation that are more prevalent among TGD than cisgender individuals Anxiety symptoms co- occur with smoking at high rates and significantly impair cessation success Similarly depressed mood and major depressive disorder both more common among individuals who smoke than among those who do not are associated with reduced odds of cessation Therefore gender minority stress and high prevalence rates of anxiety and depression render TGD individuals particularly vulnerable to smoking cessation difficulties A tailored smoking cessation intervention that builds cognitive behavioral skills for cessation as well as reduces gender minority stress and associated anxiety and depression symptoms has strong potential to mitigate tobacco use disparities among TGD individuals The investigators propose to adapt an existing smoking cessation intervention known as QUIT to address the unique needs of TGD people In focus groups with TGD individuals who use tobacco N up to 32 and providers N 8 the investigators will explore the ways in which gender minority stressors and associated anxietydepression compromise cessation as well as identify content in the current version of the QUIT intervention that does and does not meet their needs Providers will also comment on anticipated implementation barriers Following the ADAPT-ITT model the qualitative data will inform the adaptation of the intervention The investigators will then test the feasibility and acceptability of the adapted intervention QUIT in a pilot RCT N 60 the investigators will also assess for signals of clinically meaningful change in biologically verified 7-day point prevalence abstinence average number of cigarettes smoked gender minority stress anxiety and depression symptoms and distress tolerance If deemed to be feasible and acceptable the intervention will be ready for a hybrid efficacyeffectiveness trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None