- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06811896
Tilpasning av et stresshåndteringsinngrep for å redusere risikoen for kardiovaskulær sykdom
Tilpasning og pilotering av en stresshåndtering for å redusere risiko for hjerte- og karsykdommer blant kvinner som lever med HIV
Women living with HIV have 2-4x higher risk for cardiovascular disease compared to women without HIV, with women living with HIV in the Southern US being particularly at risk. While an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence suggests that increased exposure to structural and social stressors (e.g., poverty, discrimination, and stigma) among women living with HIV in the South negatively contribute to cardiovascular disease disparities through their impact on stress. The Stress Management and Resiliency Training (SMART) program is an effective, evidence-based intervention proven to improve resiliency to environmental stressors and reduce the physiologic responses to stress which contribute to cardiovascular disease. While the SMART program has demonstrated efficacy in a wide range of populations and settings, it has not been designed for or tested among women living with HIV in the South, where unique cultural and faith-based context may diminish the uptake and value of the intervention to mitigate cardiovascular disease risk. The purpose of this study is to adapt the evidence-based SMART program in consideration of the needs and contexts of women living with HIV in the Southern US and pilot the adapted intervention to establish the feasibility, acceptability, and preliminary impact of the adapted intervention to reduce stress and mitigate cardiovascular disease risk among this population.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jenni Wise, PhD, MSN
- Telefonnummer: 2059969459
- E-post: jmwise@uab.edu
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forente stater, 35294
- Rekruttering
- University of Alabama at Birmingham
-
Ta kontakt med:
- Jenni Wise, PhD, MSN
- Telefonnummer: 2059969459
- E-post: jmwise@uab.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- cis-gender females at least 18 years of age
- HIV-seropositive and a patient of the recruiting clinic
- English speaking
Exclusion Criteria:
- severe mental illness
- not being willing able to provide informed consent
- not willing or able to attend study visits
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Control
Usual Care |
Usual social and clinical services provided to patients at the recruiting clinic |
|
Annen: Intervention
Adapted Intervention, Previously Established |
The Stress Management and Resiliency Training Intervention is an evidence-based intervention to reduce physiologic responses to stress that may contribute to cardiovascular disease risk. The intervention is typically delivered over an 8-week period and works to decrease stress responses by improving psychological resiliency to structural and social stressors and decreasing sympathetic nervous system activation. Eliciting the relaxation response through meditation, mindfulness, and autogenic training are core components. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in blood pressure at baseline, week 8, and week 20
Tidsramme: baseline - week 8 - week 20
|
Measure blood pressure at baseline, end of intervention, and at 12-week follow-up |
baseline - week 8 - week 20
|
|
Change in Center for Epidemiological Studies Depression Scale Score
Tidsramme: baseline - week 8 - week 20
|
Higher score indicates more depressive symptoms (0-60 Range) |
baseline - week 8 - week 20
|
|
Change in Generalized Anxiety Disorder-7 Scale Score
Tidsramme: baseline - week 8 - week 20
|
Higher scores indicate greater symptoms of anxiety (0-21 Range) |
baseline - week 8 - week 20
|
|
Changes in Perceived Stress Scale Scores
Tidsramme: baseline - week 8 - week 20
|
Higher scores indicate greater perceived stress (0 - 40 Range) |
baseline - week 8 - week 20
|
|
Changes in Connor-Davidson Resilience Scale
Tidsramme: baseline - week 8 - week 20
|
Higher scores indicate greater resilience (0-100 Range) |
baseline - week 8 - week 20
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB-300012154
- 1K23HL170836-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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