Ignite Creation Date:
2024-05-06 @ 4:03 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02448186
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2015-04-15
Brief Title:
Intervention Development for Social Stress Mental Health and HIV Risk MSM
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Intervention Development for Social Stress Mental Health and HIV Risk Among MSM
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTEEM
Brief Summary:
The proposed study will adapt a cognitive behavioral intervention to support high-risk MSMs adaptive coping with minority stress alleviate associated depression and anxiety and reduce HIV risk behavior The adapted intervention is expected to increase awareness of the unhealthy impact of minority stress facilitate objective self-schemas in the face of minority stress and strengthen ones skills and self-efficacy for managing minority stress and associated anxiety and depression to reduce risk for acquiring HIV
Detailed Description:
Gay bisexual and other men who have sex with men MSM are the population most severely affected by HIV in the US and one of the only risk groups in the US for which new infections continue to rise MSM also experience a vastly disproportionate risk of mental health disorders especially depression and anxiety Numerous studies have shown that this mental health disparity arises from the early and ongoing stressors known as minority stress that MSM experience related to their sexual orientation Despite the fact that minority stress is strongly related to anxiety and depression and that minority stress and related mental health problems synergistically propel HIV risk behaviors no existing HIV prevention intervention targets minority stress in order to reduce MSMs HIV risk behavior This project aims to develop a theoretically-driven intervention that reduces the health-depleting effects of minority stress through targeting the basic psychosocial mechanisms linking minority stress to HIV risk behavior These mechanisms include maladaptive emotion regulation negative thinking styles low self-efficacy avoidance and impulsivity which are the very targets of an existing cognitive-behavioral manualized intervention--the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders UPTTED The UPTTED changes these mechanisms using motivational interviewing interoceptive and situational exposure cognitive restructuring mindfulness and self-monitoring exercises all grounded in cognitive-behavioral principles and developmental and affective neuroscience models of stress The proposed study will adapt the UPTTED to support high-risk MSMs adaptive coping with minority stress alleviate associated depression and anxiety and reduce HIV risk behavior The adapted UPTTED is expected to increase awareness of the unhealthy impact of minority stress facilitate objective self-schemas in the face of minority stress and strengthen ones skills and self-efficacy for managing minority stress and associated anxiety and depression to reduce risk for acquiring HIV MSM who have experienced minority stress mental health problems and HIV risk behavior in the previous 3 months n 30 and community health experts n 30 will provide suggestions for adaptations to the existing intervention manual including culturally relevant vignettes examples and exercises for adaptively responding to minority stress and managing HIV risk The feasibility acceptability and preliminary efficacy of the adapted intervention will then be tested in a randomized waitlist controlled trial with MSM n 60 who report recent experiences with minority stress depression and anxiety and HIV risk behavior The primary outcome will be HIV risk behavior Secondary outcomes will be reductions in mediators including depression anxiety and the mechanisms of the conceptual model This project innovatively seeks to test the preliminary efficacy of the first theoretically-driven intervention targeting the mental and sexual health consequences of minority stress and does so by targeting the underlying mechanisms that powerfully drive these simultaneous health threats
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