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

August 25, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37201
        • Nashville CARES Community Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adapted ESTEEM intervention
Participants will receive the adapted ESTEEM intervention over 11 sessions
Behavioral: Adapted ESTEEM intervention
culturally-responsive behavioral health intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Center for Epidemiological Studies-Depression Scale (CES-D) score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean score Ruminative Responses Scale - Brooding Subscale
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Nashville CARES

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Skyler Jackson, PhD, Yale School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000034419
  • 1K01MH122316-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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