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TENNacity Trial: A Pilot Test of Intersectional CBT Among Young Southern Black and Latino/x GBQ+ Men

25 agosto 2026 aggiornato da: Yale University

Southern TENNacity: An Open Pilot of LGBTQ-Affirmative CBT Adapted for Young Black and Latino/x Gay, Bisexual, and Queer Men in the US South

This open pilot involves testing the acceptability and feasibility of an intersectional, culturally responsive health intervention by piloting it among young Black and Latino/x gay, bisexual, and queer (GBQ+) men residing in Middle Tennessee. Qualitative exit interviews will be conducted to provide information regarding intervention feasibility, acceptability, and refinement; changes in primary and secondary study outcomes will help assess efficacy potential. Effective Skills to Empower Effective Men (ESTEEM), has been shown to decrease negative mental health symptomology and HIV risk behavior among a racially diverse sample of young GBQ+ men. This study would inform the cultural adaptation of ESTEEM to fit the unique and intersectional experiences of Black and Latino/x GBQ+ men living in the South, and in particular within Middle TN. The adaptation and group pilot stands to significantly improve stigma coping and the mental/sexual health of Black and Latino/x GBQ+ men in Middle TN-and in turn impact the HIV burden in the Southern US.

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Completato

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.

Descrizione dettagliata

These research activities seek to further the reach and cultural-appropriateness of a clinically effective evidence-based intervention (ESTEEM) by further adapting ESTEEM-conneCT (a group-based treatment designed for gay and bisexual men of color in Fair Haven, CT) for young Black and Latino/x GBM residing in Middle Tennessee. The intervention study will take place in Nashville, TN with a partnership between the Nashville CARES and the Yale School of Public Health (YSPH). This pilot will guide further refinement, identify facilitators and barriers to scaling up, and yield effect size estimates for powering future studies.

Tipo di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Interventistico

Iscrizione (Effettivo)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
20

Fase

Fase

La fase di una sperimentazione clinica che studia un farmaco o un prodotto biologico, sulla base delle definizioni sviluppate dalla Food and Drug Administration (FDA) statunitense. La fase si basa sull'obiettivo dello studio, sul numero di partecipanti e su altre caratteristiche. Ci sono cinque fasi: Early Phase 1 (precedentemente indicata come Fase 0), Phase 1, Phase 2, Phase 3 e Phase 4. Not Applicable è usato per descrivere sperimentazioni senza fasi definite dalla FDA, incluse sperimentazioni di dispositivi o interventi comportamentali.
  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37201
        • Nashville CARES Community Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • identify as male
  • anticipate 6-months of residential stability in Nashville (or surrounding service area)
  • identify as gay, bisexual, or report past-12-month sex with a man
  • identify as Black and/or Latino
  • speak fluent English
  • provide consent

Exclusion Criteria:

  • exhibit symptoms of psychosis, mania, or gross cognitive impairment (assessed by a clinician during pre-assessment)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm

Gruppo di partecipanti / Arm

Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.
Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: Adapted ESTEEM intervention
Participants will receive the adapted ESTEEM intervention over 11 sessions
Comportamentale: Adapted ESTEEM intervention
culturally-responsive behavioral health intervention

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
Center for Epidemiological Studies-Depression Scale (CES-D) score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The CES-D is a 20-item measure that assesses frequency of past-week depression symptoms (e.g., "I was bothered by things that usually don't bother me") on a 4-point scale from 0 (rarely or none of the time [less than 1 day]) to 3 (most or all of the time [5-7 days]). The item scores are summed, with higher scores indicating greater risk for clinical depression. Total score range 0-80.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Overall Depression Severity and Impairment Scale (ODSIS) score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
ODSIS is a 5-item self-report scale that asks participants to rate the severity and impairment associated with past-week symptoms of depression (e.g., "In the past week, when you have felt depressed, how intense or severe was your depression?") from 0 (little or none: Depression was absent or barely noticeable.) to 4 (extreme: Depression was overwhelming.). The item scores are summed, with higher scores indicating greater severity and impairment. Total score range 0-20.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Overall Anxiety Severity and Impairment Scale (OASIS) score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
OASIS is a 5-item self-report scale that asks participants to rate the severity and impairment associated with past-week anxiety symptoms (e.g., "In the past week, when you have felt anxious, how intense or severe was your anxiety?") from 0 (little or none: Anxiety was absent or barely noticeable.) to 4 (extreme: Anxiety was overwhelming. It was impossible to relax at all. Physical symptoms were unbearable). The item scores are summed, with higher scores indicating greater severity and impairment. Total score range 0-20.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Brief Symptom Inventory (BSI) score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The 18-item BSI provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely). The item scores are summed with higher scores indicating greater severity and impairment. Total score range 0-72.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Suicidal Ideation Attributes Scale (SIDAS) score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
SIDAS is a 5-item self-report scale that assesses past-month frequency and controllability of suicidal thoughts, how close one has come to making an attempt, and distress and impairment associated with thoughts of suicide (e.g., "In the past month, how often have you had thoughts about suicide?"). Responses range from 0 (never or not at all) to 10 (always or extremely). The item scores are summed, with higher scores indicating greater severity of suicidal ideation. Total score range 0-50.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Short Inventory of Problems - Alcohol and Drugs (SIP-AD) score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use?). The item scores are summed, with higher scores indicating greater problems related to drugs and alcohol. Total score range 0-15.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Mean Recent HIV-risk Acts
Lasso di tempo: Baseline (0-30 days before the start of the trial) and post-intervention (three months after the trial)
Mean Number of Recent HIV-risk Acts self reported using the timeline follow-back method
Baseline (0-30 days before the start of the trial) and post-intervention (three months after the trial)
Psychological Health Change
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The number of the mental health variables that change in the expected direction. The eight psychological health variables include: depressive symptoms; anxiety; social anxiety; suicidal ideation; psychological distress; substance use problems; rumination; and assertiveness.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Sexual Health Change
Lasso di tempo: Baseline (0-30 days before the start of the trial) and post-intervention (three months after the trial)
The number of sexual health variables that change in the expected direction. The four sexual health variables include: Recent HIV transmission risk acts; condom use self-efficacy; sexual compulsivity; and recent PrEP use.
Baseline (0-30 days before the start of the trial) and post-intervention (three months after the trial)
Social Interaction Anxiety Scale score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
A 20-item self-report scale that assesses fear, distress, and anxiety a person feels during general social interactions. Responses range from 0 (Not at all characteristic of me) to 4 (Extremely characteristic of me). The item scores are summed, with higher scores indicating greater level of social anxiety. Total score range 0-80.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

Misure di risultato secondarie

Misure di risultato secondarie

Nel protocollo di uno studio clinico, una misura dell'esito pianificato che non è importante quanto la misura dell'esito primario per valutare l'effetto di un intervento ma è comunque di interesse. La maggior parte degli studi clinici ha più di una misura di esito secondaria.
Misura del risultato
Misura Descrizione
Lasso di tempo
Mean score Ruminative Responses Scale - Brooding Subscale
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The Brooding Subscale is a 5-item measure that assesses maladaptive cognitive patterns when feeling down, sad, or depressed (e.g., "Think 'why do I always react this way?'") on a 4-point scale from 1 (Almost Never) to 4 (Almost Always). The item scores are averaged, with higher scores indicating greater ruminative brooding. Total score range 0-4.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Rathus Assertiveness Schedule score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The Rathus Assertiveness Schedule is a 30-item measure that assesses assertiveness and passivity (e.g., "I often have a hard time saying 'No.'") on a 6-point scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me). The item scores are summed, with positive scores indicating higher assertiveness and negative scores indicating lower assertiveness or passivity. Total score range 90 to -90.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Alcohol Use Disorders Identification Test (AUDIT) score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The AUDIT assesses past-3-month alcohol and related problems across 10 items (e.g., "How often did you have a drink containing alcohol?") with varying numeric response options (0-4). The item scores are summed, with higher scores indicating greater alcohol-related risk. Total score range 0-40.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Mean score Safer Sex Self-Efficacy Questionnaire
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Condom use self-efficacy will be measured by calculating mean scores on the Safer Sex Self-Efficacy Questionnaire. The Safer Sex Self-Efficacy Questionnaire is a 13-item measure that assesses confidence in avoiding having anal sex without a condom in different situations (e.g., "When you are with someone who is really hot?") on a 5-point scale from 1 (Not at all confident) to 5 (Extremely confident). The item scores are averaged, with higher scores indicating greater condom use self-efficacy. Total score range 1-13.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Sexual Compulsivity Scale score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The Sexual Compulsivity Scale is a 10-item measure that assesses difficulties regulating sexual desire (e.g., "I think about sex more than I would like to") on a 4-point scale from 1 (Not at all lke me) to 4 (Very much like m). The item scores are summed, with higher scores indicating greater Sexual Compulsivity. Total score range 10-40.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Percent participants with recent PrEP use
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Recent PrEP use will be measured by calculating proportions of participants who reported any PrEP use over the past 3 months. Three types of PrEP were described before participants were asked, "Which methods of PrEP (Pre-Exposure Prophylaxis) administration have you used to reduce the risk of getting HIV over the past 3 months? Select all that apply." Answer options included Daily PrEP (i.e., 4-7 days a week), On-demand PrEP (i.e., the "2-1-1" schedule), Injectable PrEP (i.e., every two months), and I have not taken PrEP in any form over the past three months.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Stigma Coping Strategies
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Number of protective strategies that increased and risk-enhancing strategies that decreased.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Stigma Coping- Adaptiveness Scale score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Coping response will be scored on a 5-point adaptiveness scale (created for this study) ranging from 1 (Definitely adaptive [or almost certainly so]) to 5 (Definitely maladaptive [or almost certainly so]) with higher scores indicating worse coping. Total score range 1-5.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Internalized Homophobia Scale score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The Internalized Homophobia Scale is a 9-item measure that assesses internalized homophobia on a 4-point scale from 1 (Never) to 4 (Often). The item scores are summed, with higher scores indicating greater internalized homophobia. Total score range 9-36.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Gay-Related Rejection Sensitivity Scale score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The Gay-Related Rejection Sensitivity Scale is a 14-item measure that the likelihood of expecting rejection by heterosexuals in more or less ambiguous situations with answers on a scale ranging from 1 to 6 with higher scores indicating greater rejection. Total score range 1-6.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Mean Outness Inventory (OI) score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The OI is an 11-item scale designed to assess the degree to which lesbian, gay, bisexual, and queer individuals are open about their sexual orientation. Responses on OI items indicate the degree to which the respondent's sexual orientation is known by and openly discussed with various types of individuals on a 7-point scale from 1 (person definitely does NOT know about your sexual orientation status) to 7 (person definitely knows about your sexual orientation status, and it is OPENLY talked about); if the person of group is not relevant to them, participants select 0 (not applicable to your situation; there is no such person or group of people in your life). The item scores are averaged, with higher scores indicating greater sexual orientation disclosure. Total score range 0-4.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Mean Sexual Orientation Concealment Scale (SOCS) score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
This version of the Self-Concealment Scale is a 6-item measure that assesses sexual ), a brief self-report measure assessing effort to conceal one's sexual identity in one's current life (e.g., "In the last 2 weeks, I have altered my appearance, mannerisms, or activities in an attempt to 'pass' as straight.") on a 5-point scale from 1 (Not at all) to 5 (All the time). The item scores are averaged, with higher scores indicating greater concealment. Total score range 1-5.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Internalized Racism score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Internalized racism will be measured as mean of participant scores on a 5-item measure that assesses negative thoughts and beliefs about one's own racial minority status. Participants were presented with a question regarding their racial/ethnic identity (e.g., "How do you feel today about being a person of your racial/ethnic background?"), which they answer by completing five semantic differential scales, each ranging from 1 (a negative characteristic) to 5 (a corresponding positive characteristic): uncomfortable to comfortable, dissatisfied to satisfied, ashamed to proud, strong to weak, and self-accepting to self-rejecting. The item scores are summed, with higher scores indicating greater internalized racism. Total score range 5-25.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Mean Racism-Related Vigilance scale score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The scale is a 7-item measure includes four items that assess (a) racial/ethnic vigilance (e.g., "try to prepare for possible insults from other people before leaving home") on a 4-point scale from 0 (Rarely) to 3 (Almost every day), total score range 0-3.and (b) race-related sleep disturbance over the past four weeks (e.g., waking very early with trouble getting back to sleep) on a 5-point scale from 1 (At least once a week) to 5 (Never), total score range 1-5. The item scores are averaged, with higher scores indicating greater race-related vigilance.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Anticipatory Race-Related Stress Subscale of the Prolonged Activation and Anticipatory Race-Related Stress Scale score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The Anticipatory Race-Related Stress Subscale is a 4-item measure that assesses race-related anticipatory stress on a 7-point scale from 1 (Not at all stressful) to 7 (Extremely Stressful). The item scores are averaged, with higher scores indicating greater race-related anticipatory stress. Total score range 1-7.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Heterosexism & Cissexism in Communities of Color Subscale of the LGBTQ+ PCMS-R score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
This is a 6-item subscale measure that assesses perceived heterosexism within one's racial/ethnic community on a 7-point scale from 0 (Not applicable) to 6 (Always). Then, participants are presented with directions reading, "Imagining if you were to experience ongoing anti-LGBTQ stigma within your racial/ethnic community, such as:" and all six subscale items were presented. They are then asked, "If you were to encounter situations like these..." before encountering three follow-up questions to assess distress (e.g., "to what extent would the situation stress or bother you?"). The initial subscale score is multiplied by the stress score to compute stress related to heterosexism in one's racial/ethnic community, with higher scores indicating greater intracommunity heterosexism. Total score range 0-30.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Racism within LGBTQ+ Communities Subscale of the LGBTQ+ PCMS-R score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
This is a 6-item subscale measure that assesses perceived racism in the White LGBTQ+ community (e.g., "I have felt misunderstood by White LGBTQ+ people because I am a POC.") on a 5-point scale from 1 (To a little extent) to 5 (To a great extent). Then, participants are presented with directions reading, "Imagining if you were to experience ongoing racism within the LGBTQ+ community, such as:" and all six subscale items were presented. They are then asked, "If you were to encounter situations like these..." before encountering three follow-up questions to assess distress (e.g., "to what extent would the situation stress or bother you?"). The initial subscale score is multiplied by the stress score to compute stress related to heterosexism in one's racial/ethnic community, with higher scores indicating greater intracommunity heterosexism. Total score range 0-30.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Conflicts in Allegiances Scale score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
The Conflicts in Allegiances Scale is a 6-item subscale measure that assesses conflicts between the racial/ethnic and sexual orientation identities they endorsed previously within the survey (e.g., "I separate my [insert sexual orientation] and [insert racial/ethnic group] identities.") on a 7-point scale from 1 (Disagree strongly) to 7 (Agree strongly). The item scores are averaged, with higher scores indicating greater identity conflict. Total score range 1-7.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Queer People of Color Identity Affirmation Scale score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
This is a 12-item measure that assesses identity affirmation among LGBTQ+ people of color on a 7-point scale from 1 (Very strongly disagree) to 7 (Very strongly agree). The item scores are averaged, with higher scores indicating greater Southern LGBTQ-POC identity strength. Total score range 1-7.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Queer and Trans Black, Indigenous, and People of Color (QT-BIPOC) Resilience Measure score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
This is a 20-item subscale measure that assesses the ways oppression has shaped their individuals and community QT-BIPOC resilience on a 7-point scale from 1 (Strongly Disagree) to 7 (Strongly Agree). The item scores are averaged, with higher scores indicating greater intersectional stigma resilience. Total score range 1-7.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Stigma-Related Stress Change
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Number of the mental health variables that change in the expected direction out of the 13 psychological health variables.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
Perseverative Cognition Subscale Subscale of the Prolonged Activation and Anticipatory Race-Related Stress Scale score
Lasso di tempo: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)]
The Perseverative Cognition Subscale Subscale is a 5-item measure that assesses race-related rumination on a 7-point scale from 1 (Not at all stressful) to 7 (Extremely stressful). The item scores are averaged, with higher scores indicating greater race-related anticipatory stress. Total score range 1-7.
Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)]

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
Yale University

Collaboratori

Collaboratori

Un'organizzazione diversa dallo sponsor che fornisce supporto per uno studio clinico. Questo supporto può includere attività relative al finanziamento, alla progettazione, all'implementazione, all'analisi dei dati o al reporting.
National Institute of Mental Health (NIMH)
Nashville CARES

Investigatori

Investigatori

Un ricercatore coinvolto in uno studio clinico. I termini correlati includono il ricercatore principale del sito, il ricercatore secondario del sito, il presidente dello studio, il direttore dello studio e il ricercatore principale dello studio.
  • Investigatore principale: Skyler Jackson, PhD, Yale School of Public Health

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
16 aprile 2025

Completamento primario (Effettivo)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
19 novembre 2025

Completamento dello studio (Effettivo)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
19 novembre 2025

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
25 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
25 agosto 2026

Primo Inserito (Effettivo)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
28 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
28 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
25 agosto 2026

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
  • 2000034419
  • 1K01MH122316-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified qualitative and quantitative IPD will be preserved and shared with qualified researchers upon request.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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