A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans (SH-SP)

March 4, 2026 updated by: VA Office of Research and Development
Risk of Veteran suicide is elevated during the first year of transition from military service to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA healthcare. Suicide prevention and connection to care are therefore critical for recently transitioning Veterans. Transitioning Veterans require services to provide them with suicide prevention education, skills to manage their transition effectively, and support in their access to VA healthcare. Convenient, accessible, palatable, patient-centered care options that are cost-effective, easy to implement nationwide, and target domains known to mitigate suicide risk are needed during this critical transition period. This proposal would bridge this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing, skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education, skills to improve transition, support to access VA care, and a platform to decrease social isolation early in their military to civilian transition, thereby reducing suicide risk downstream.

Study Overview

Status

Status

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

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

Veterans face a "deadly gap" during their first year of transition from military to civilian life with limited available psychiatric services and increased suicide risk factors. During this critical transition period, Veteran suicide rate is double that of active service members and the general Veteran population. An average of 20 Veterans die from suicide each day, but only 6 of the 20 use VA services. VA care engagement has been shown to mitigate suicide risk; therefore, promoting engagement during the "deadly gap" could be essential to suicide prevention. Transitioning Veterans require outreach and services to provide them with support in their access to VA healthcare, suicide prevention education, and skills to manage their transition effectively. This proposal would bridge this important healthcare gap using STEP-Home. STEP-Home is an evidence-based, transdiagnostic, video telehealth rehabilitation workshop to improve reintegration, social support, and functioning among Veterans with high clinical comorbidity. STEP-Home is non-clinical, cost-effective, and skills-focused to maximally engage Veterans not participating in treatment who may be resistant to traditional "mental health" diagnostically focused approaches. To date, STEP-Home has not been adapted for the unique needs of recently transitioning Veterans or augmented for suicide prevention. This proposal will adapt and refine STEP-Home specifically for recently transitioning Veterans and add suicide prevention content and skills to create STEP-Home-SP. The proposed pilot study is designed to support STEP-Home and suicide prevention content experts in their refinement and evaluation of STEP-Home-SP. The investigators will utilize the VA/Department of Defense Identity Repository (VADIR) to recruit recently transitioned Veterans nationwide. In Aim 1, the investigators will develop STEP-Home-SP by adapting the STEP-Home telehealth intervention to specifically target recently transitioned Veterans and augment the workshop to include suicide prevention. In Aim 2, the investigators will conduct a two-arm proof-of-concept acceptability and feasibility randomized controlled trial (RCT) of STEP-Home-SP versus Enhanced Usual Care (EUC=current standard of care + educational packet on suicide risk and connection to VA care) in recently transitioned Veterans. Lastly, the investigators will explore reintegration status, VA care initiation, and candidate outcomes for STEP-Home-SP relative to EUC to inform a future full-scale RCT. If successful, fostering social, vocational, and community connection; building emotion regulation and impulse control skills; facilitating safety planning; and providing education and access to VA care upstream should result in decreased suicide risk during this critical transition and beyond.

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 (Estimated)

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.
120

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130-4817
        • Recruiting
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
        • Principal Investigator:
          • Catherine B Fortier, PhD
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Recently transitioned Veterans within three years of separation from military service
  • Self-reported functional impairment or reintegration difficulties as measured by the Military-to-Civilian Questionnaire (any item score > 1 indicating "some difficulty"; M2CQ; [71])
  • Sufficient English fluency
  • Agree to participate (informed consent/HIPAA)

Exclusion Criteria:

  • Active psychosis
  • Imminent or acute high suicide risk requiring immediate crisis intervention (low-moderate non-imminent risk for suicide is allowed)
  • Current moderate or severe substance use disorder

  • Neurological diagnosis excluding TBI

    • Participants with mild substance use disorder will be allowed
    • Substance use is a common behavior that may contribute to reintegration difficulties and suicide risk

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: Randomized
  • Interventional Model: Parallel 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: STEP-Home-SP + Usual Care
The core skills of emotional regulation and problem solving are introduced and integrated throughout all Veteran-specific reintegration content modules for practice and repetition for 12 weeks. Attention training augments emotional regulation and problem solving core skills and is interspersed throughout group and individual sessions. Additional 30-minute individual skill building and goal setting sessions occur ~4-6 times based on individual Veteran needs
Behavioral: STEP-Home-SP
This group will meet for ~1.5 hours/week for 12 weeks. The core skills of Emotional Regulation (ER) and Problem Solving (PS) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention training augments ER and PS skills and is interspersed throughout the group and individual sessions. Additional 30-minute individual skills building and goal setting sessions occur up to 6 times based on individual Veteran needs. STEP-Home staff will work in pairs to run workshops per established protocols. Workshops will be conducted via VA approved video telehealth.
Behavioral: Transition Assistance Program
Provides training, skills, and information to help transitioning service members and their families prepare for the military to civilian transition. Each service member works with a TAP counselor to identify needs and post transition goals to build an Individual Transition Plan, in addition to TAP core curriculum courses.
Other Names:
  • TAP
Behavioral: VA Solid Start
VA Solid Start includes a series of outreach calls and emails to all Veterans at 90-, 180-, and 365-days post service separation. Callers follow a standard script to describe services available through VA and provide contact information for desired services.
Active Comparator: Usual Care
UC will include the Transition Assistance Program (TAP) as scheduled by DOD prior to military separation, VA Solid Start post-separation, and educational augmentation post-separation.
Behavioral: Transition Assistance Program
Provides training, skills, and information to help transitioning service members and their families prepare for the military to civilian transition. Each service member works with a TAP counselor to identify needs and post transition goals to build an Individual Transition Plan, in addition to TAP core curriculum courses.
Other Names:
  • TAP
Behavioral: VA Solid Start
VA Solid Start includes a series of outreach calls and emails to all Veterans at 90-, 180-, and 365-days post service separation. Callers follow a standard script to describe services available through VA and provide contact information for desired services.

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
Feasibility- recruitment interest
Time Frame: Through study completion, an average of one year.
ratio interested of those approached for the workshop
Through study completion, an average of one year.
Feasibility- enrollment
Time Frame: Through study completion, an average of one year.
Ratio enrolled (consented) of those approached, greater than 20% of those interested enroll in the proposed time frame
Through study completion, an average of one year.
Feasibility- qualitative via Narrative Evaluation of Intervention Interview
Time Frame: Through study completion, an average of 3 months.
Identification of challenges and facilitators during the recruitment process as assessed by study staff as well as feedback from focus group participants generated using the Narrative Evaluation of Intervention Interview (NEII). This is an interview composed of 16 open ended questions that allows participants to evaluate the process and outcomes of the intervention. Reviewers will generate a list of themes based on the responses to this interview.
Through study completion, an average of 3 months.
Feasibility- Treatment Fidelity/adherence
Time Frame: Through study completion, an average of 1 week.
Supervisor and therapist Likert rating of adherence to content for core skills and treatment modules, less than 20% deviations on a treatment fidelity scale. Lower scores indicate stronger treatment fidelity, with each question being answered on a scale from 1 (Strongly Agree) to 5 (Strongly Disagree).
Through study completion, an average of 1 week.
Acceptability- Veteran adherence
Time Frame: Through study completion, an average of one year.
Attendance rate for the 12-session workshop
Through study completion, an average of one year.
Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Client satisfaction questionnaire (CSQ-8), total scores range from 8 to 32 with higher scores indicating higher satisfaction. A priori criteria is that greater than 80% of participants will score greater that a 24 on the CSQ-8.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Reintegration status- Military to Civilian Questionnaire (M2CQ) Change
Time Frame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks) and T5 (after 24 weeks)
16 questions are answered on a scale from 0 (no difficulty) to 4 (extreme difficulty), with lower scores indicating more successful reintegration.
Assessed at screening, baseline (0 weeks), T4 (after 12 weeks) and T5 (after 24 weeks)

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
Engagement in VA Care
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Electronic medical record data (if available) showing occurrence of one or more healthcare appointments
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difficulties in Emotional Regulation Scale (DERS)
Time Frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
36 statements are each ranked on the following scale by participants: 1 almost never (0-10%), 2 sometimes (11-35%), 3 about half the time (36-55%), 4 most of the time (66-90%), or 5 almost always (91-100%). This produces scores for 6 subscales: nonacceptance of emotional responses; difficulty engaging in goal-directed behavior; impulse control difficulties; lack of emotional awareness; limited access to emotion regulation strategies; lack of emotional clarity.
Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Problem Solving Inventory (PSI)
Time Frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Participants rank 35 statements on a Likert scale from 1 (strongly agree) to 6 (strongly disagree). This generates a total score and 3 subscale scores for the following categories: Approach Avoidance, Personal Control, and Problem Solving Confidence.
Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Attention-Related Cognitive Errors Scale (ARCES)
Time Frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
12 questions are ranked on a Likert Scale from 1 (never) to 5 (very often) with higher scores indicating more frequent attention related cognitive errors.
Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Suicidal Ideation- The Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Assessed at screening, baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks). Will also be administered as needed following workshop sessions.
Participants are asked 5 questions designed to assess severity of suicide risk. Questions are answered yes or no, with endorsement of active suicidal ideation with intent being considered high risk and suicidal ideation without intent considered moderate risk.
Assessed at screening, baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks). Will also be administered as needed following workshop sessions.
Post-deployment Readjustment Inventory (PDRI)
Time Frame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
36 statements are ranked by participants on a scale from 1 (not at all) to 5 (extremely). Total score is calculated by the sum of each of the subscales: Career, Health, Intimate relationships, social readjustment, concerns about deployment, and PTSD symptoms. Higher scores indicate less successful post-deployment readjustment.
Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
State-Trait Anger Expression Inventory (STAXI-2)
Time Frame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Measures the experience, expression, and control of anger. Participants rank each of the statements on a scale of 1 (not at all) to 4 (very much so) for section 1 and 1 (almost never) to 4 (almost always) for sections 2 and 3. Higher scores indicate high experience/expression and low control of anger.
Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Functional status measured using the WHO Disability Assessment Schedule 2.0 12-item (WHODAS-2.0)
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Participants indicate how much difficulty they have had in the last 30 days for each of the statements on the assessment on a scale from 0 (none) to 4 (Extreme/cannot do). Higher scores indicate greater levels of disability.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Stigma- Perceived Barriers to Care Survey
Time Frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Participants rank each of the survey items on the scale from 1 (strongly agree) to 5 (strongly disagree) with lower scores indicating that the item is a greater barrier to care.
Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Quality of Life Scale (QOLS)
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Participants answer each question on a 7 point scale. It is scored by adding up the score on each item to get a minimum potential score of 16 and a maximum total score of 112. Higher scores indicate a higher quality of life.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Psychosocial Functioning- The Brief Inventory of Psychosocial Functioning (IPF-Brief)
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Participants rank each of the 7 statements based on their overall experience over the past month on a scale from 0 (not at all) to 6 (very much). 7 is marked if the statement is not applicable. Higher scores indicate more impaired psychosocial functioning.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Social support subscale of the Deployment Risk and Resilience Inventory (DRRI-2)
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Participants rank each of the ten questions from this subscale on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree) and total subscale score is calculated by adding up the responses from each of the questions. Lower scores indicate lower levels of social support.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Interpersonal Needs Questionnaire (INQ)
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Each of the 15 questions are answered on a scale from 1 (Not at all true for me) to 7 (very true for me). 6 out of the 15 questions are reverse coded. Higher scores indicate that more interpersonal needs are not met.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Depression- Patient Health Questionnaire (PHQ-9)
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Participants rank 9 questions on a scale from 0 (not at all) to 3 (Nearly every day) based on how often in the last 2 weeks they have been bothered by the problems listed. Then they rate the severity of the difficulty any problems they have experienced are causing on a scale from "not difficult at all" to "extremely difficult." Higher scores indicate higher depression severity.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Hopelessness- Beck Hopelessness Scale
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Participants answer 20 true or false questions that are scored based on an answer key. Answers that indicate hopelessness are added up, with higher scores indicating higher levels of hopelessness/pessimism.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Self-injurious thoughts and behaviors interview (SITBI)
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
This interview asks a wide variety of questions related to suicidal ideations, plans, gestures, attempts, and non-suicidal self injurious behaviors. There are 72 possible questions, but some are only asked if a specific behavior is endorsed. Higher scores indicate higher levels of thoughts and feelings related to suicide and self-injurious behaviors.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Suicide Coping/Safety Behaviors- Suicide Related Coping Scale (SRCS)
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Participants answer 17 questions on a 5 point Likert scale from 0-4 (Strongly Disagree to Strongly Agree). Total score is determined by reverse scoring negatively worded items and then summing the items. Higher scores indicate better coping skills.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Gateway to vocational and community activities- Treatment & Activities Survey
Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Treatment & Activities Survey developed by STEP-Home staff asks participants to list the types of treatment (psychotherapy, medication, group therapy) that they have participated in within the last month, what they receive the treatment for, and whether it is administered by the VA or outside of the VA. Participants also answer if they have participated in other activities in the last month (school, work, community, etc.) and whether those activities are at or outside of the VA.
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Kessler-6 brief mental health screen
Time Frame: Baseline (0 weeks)
The Kessler Psychological Distress Scale (K6) is a 6 item measure of participants' emotional state. Questions are scored from 0 (none of the time) to 4 (all of the time) with a minimum score of 0 and a maximum score of 24. Higher scores indicate higher levels of psychological distress.
Baseline (0 weeks)

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.
VA Office of Research and Development

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: Catherine B Fortier, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

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.
March 1, 2024

Primary Completion (Estimated)

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.
May 31, 2027

Study Completion (Estimated)

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.
May 31, 2027

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).
June 20, 2023

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 15, 2023

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 16, 2023

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.
March 6, 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.
March 4, 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.
March 1, 2026

More Information

Terms related to this study

Keywords

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.
  • D4535-R
  • RX004535 (Other Grant/Funding Number: VA ORD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No additional IPD will be shared besides the deidentified/anonymized data set and data dictionary will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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