Self-directed ViolenceNCT05974631
Evaluating Treatments for Suicidal Veterans With PTSD
A study testing Dialectical Behavior Therapy, Dialectical Behavior Therapy Prolonged Exposure protocol and Prolonged Exposure therapy in people with Self-directed Violence and Post-traumatic Stress Disorder (PTSD), run by VA Office of Research and Development at 4 sites in United States.
Trial summary
Posttraumatic Stress Disorder (PTSD) is a significant driver of suicide risk among Veterans, but there is a critical knowledge gap about how to treat PTSD among people at elevated risk for suicide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self-directed Violence, Post-traumatic Stress Disorder (PTSD)
- What is being tested?
- Dialectical Behavior Therapy, Dialectical Behavior Therapy Prolonged Exposure protocol and Prolonged Exposure therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Jul 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTSD
- Recent and repeated self-directed violence
- Current suicidal ideation
- Emotion dysregulation
- Veteran eligible for VHA mental health care at participating site
- Willing to participate in all study activities
Who cannot join
- Unable to maintain safety independently
- Currently engaged in and/or recent (past year) history of receiving a sufficient dose of DBT or PE
- Plan to move away or be unavailable for >4 weeks in the next 18 months
- Unable to sufficiently comprehend study procedures due to lack of English proficiency or moderate to severe cognitive impairment
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Daniel Blalock, PhD, (919) 286-0411 ext. 174026, daniel.blalock@va.gov
Charlotte Ready, PhD, (919) 286-0411 ext. 177062, Charlotte.Ready@va.gov
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Lindsay Andrews-Wiebusch, PhD, (612) 629-7656, Lindsay.Andrews-Wiebusch@va.gov
Laura A Meis, PhD, (612) 467-4516, laura.meis@va.gov
- Recruiting
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229-4404
Julia Carter, PhD, 830-237-2958, julia.carter@va.gov
- Recruiting
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
Melanie S Harned, PhD, (206) 277-3650, melanie.harned@va.gov
John C Fortney, PhD, (206) 764-2821, John.Fortney@va.gov
About this study
Official title: A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans With PTSD at Elevated Acute Risk for Suicide
Posttraumatic Stress Disorder (PTSD) is a significant driver of suicide risk among Veterans, but there is a critical knowledge gap about how to treat PTSD among people at elevated risk for suicide. Although evidence-based treatments for PTSD reduce suicide risk, Veterans at high risk for suicidal behavior rarely receive these potentially life-saving treatments. Prior research suggests that a treatment that combines Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure protocol (DBT PE) for PTSD improves both PTSD and suicide-related outcomes. This study will evaluate whether DBT + DBT PE improves these outcomes more than Prolonged Exposure plus suicide risk management, the gold standard VA care for this population. The proposed study will also examine factors that make it easier and harder to implement these treatments in VA settings. The results will help to inform treatment guidelines for this high-priority Veteran population.
Read the detailed description
Background: Posttraumatic stress disorder (PTSD) is a significant risk factor for suicide among Veterans. Evidence-based psychotherapies (EBPs) for PTSD reduce suicide risk, but Veterans at elevated acute risk for suicide, such as those who have engaged in self-directed violence (SDV), rarely receive these treatments. This is largely due to the historical exclusion of high-risk individuals from PTSD treatment trials, which has resulted in a lack of evidence-based guidance about indicated treatments for this population. Without such guidance, clinicians are often reluctant to use EBPs for PTSD with suicidal individuals. A treatment that combines Dialectical Behavior Therapy (DBT), a suicide-focused EBP, with the DBT Prolonged Exposure (DBT PE) protocol for PTSD has been developed for this high-risk population and shows promise in reducing both SDV and PTSD while being feasible, acceptable, and safe to deliver. However, a large-scale randomized controlled trial (RCT) is needed. This study will compare the effectiveness of DBT + DBT PE to the current VHA gold standard of care for this population, Prolonged Exposure therapy augmented with suicide risk management (PE + SRM), while also examining the potential for implementation of both interventions in VHA.
Significance: There is a critical gap in knowledge about how to treat PTSD among individuals at high risk for suicidal behavior. As a result, VA/DoD Clinical Practice Guidelines do not specify indicated treatment strategies for this population. Experts have recommended two approaches to facilitate the safe and effective use of EBPs for PTSD with individuals at elevated acute suicide risk, including combining these treatments with suicide-focused EBPs or augmenting them with suicide risk management strategies. This project will help to fill this critical gap by rigorously evaluating these two approaches among Veterans with SDV. The results will provide important information to inform guidelines about indicated treatments for this high-risk population.
Innovativeness: This will be the first large-scale RCT to evaluate treatments for PTSD among Veterans who have engaged in SDV, an HSR\&D high priority group. The DBT + DBT PE intervention is the first treatment designed to address both SDV and PTSD, and results will indicate if this novel treatment improves outcomes compared to the current VHA gold standard of care. To facilitate more rapid implementation of these findings into clinical practice, implementation barriers and facilitators for both treatments will also be evaluated.
Specific Aims: This study will randomize 125 Veterans with PTSD, recent and repeated SDV, current suicidal ideation, and emotion dysregulation to DBT + DBT PE (intervention) or PE + SRM (control). Aim 1 will test the hypothesis that DBT + DBT PE will be superior to PE + SRM in improving clinical outcomes and engagement in trauma-focused treatment. Exploratory analyses will examine Veteran characteristics that may predict better engagement and outcomes in DBT + DBT PE versus PE + SRM. Aim 2 will examine barriers and facilitators to implementation of both treatments.
Methods: This is a multi-site hybrid type 1 effectiveness-implementation trial. Veterans will be treated in outpatient settings at four VA sites and assessed at 5 points over 16 months. A mixed-methods approach will be used to evaluate barriers and facilitators to implementation, including conducting interviews with 45 key stakeholders (Veterans, providers, and leadership).
Primary Outcomes/Endpoints: Primary outcomes will be reductions in SDV episodes at 16-month follow-up and reductions in PTSD severity at post-treatment.
Implementation/Next Steps: This project will provide much-needed information about how to safely and effectively treat PTSD among Veterans at elevated acute risk for suicide. If one or both treatments are found effective, Aim 2 will provide vital information about how to maximize future implementation success. Future implementation activities would be coordinated with the investigators' national operational partners.
- Being tested
- Dialectical Behavior Therapy, Dialectical Behavior Therapy Prolonged Exposure protocol, Prolonged Exposure therapy, Suicide risk management
- Keywords
- Stress Disorders, Post-Traumatic, Suicide, Self-Injurious Behavior
- Medical subject headings
- Stress Disorders, Post-Traumatic, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior TherapyBehavioural
Also called DBT
Standard Dialectical Behavior Therapy (DBT), including DBT individual therapy (1 hour/week), DBT group skills training (2 hours/week), between-session coaching (as needed during business hours), and therapist consultation team (1-1.5 hours/week).
Dialectical Behavior Therapy Prolonged Exposure protocolBehavioural
Also called DBT PE
DBT PE is designed to be integrated into DBT to formally treat PTSD once patients meet standardized readiness criteria. The core procedures are in vivo and imaginal exposure with processing that are delivered in individual therapy sessions (1.5 hours/week).
Prolonged Exposure therapyBehavioural
Also called PE
Standard PE is delivered in individual therapy sessions (1.5 hours/week) and uses the core procedures of in vivo and imaginal exposure with processing.
Suicide risk managementBehavioural
Also called SRM
Standard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning.
| Study group | Role | What they receive |
|---|---|---|
| DBT + DBT PE | Experimental | This condition combines one year of standard Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure (DBT PE) protocol for PTSD. Receives: Behavioral: Dialectical Behavior Therapy; Behavioral: Dialectical Behavior Therapy Prolonged Exposure protocol |
| PE + SRM | Active comparator | This condition provides up to 18 sessions of Prolonged Exposure therapy (PE) for PTSD augmented with suicide risk management (SRM). Receives: Behavioral: Prolonged Exposure therapy; Behavioral: Suicide risk management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)
Number of self-directed violence episodes
Measured: Baseline to 16 months
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Total Severity Score (range = 0 - 200, higher is worse)
Measured: Baseline to 16 months
Secondary outcomes (6)
Columbia - Suicide Severity Rating Scale (C-SSRS), Suicide Ideation subscales
Total Score (range = 0 - 5, higher is worse)
Measured: Baseline to 16 months
PROMIS Global Mental Health
Total Score (range = 4 - 20, higher is better)
Measured: Baseline to 16 months
Difficulties in Emotion Regulation Scale-16 (DERS-16)
Total Score (range = 16 - 80, higher is worse)
Measured: Baseline to 16 months
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
General Disability Score (range = 12 - 60, higher is worse)
Measured: Baseline to 16 months
Self-Injurious Thoughts and Behaviors Interview Revised Short Form (SITBI-R-SF)
Non-suicidal self-injury frequency and remission; Suicide attempt frequency and remission
Measured: Baseline to 16 months
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
PTSD diagnostic status
Measured: Baseline to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start8 Jul 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-directed ViolenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Melanie S Harned, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974631
- Sponsor's protocol ID
- SDR 22-185
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, anonymized data that underlie results in a publication may be shared.
Publications
Harned MS, Ready CB, Andrews Wiebusch LM, Landes SJ, Blalock DV, Waddell ZE, Carter JM, Hembree EA, Meis LA. Evaluating psychotherapies for veterans with PTSD at elevated acute risk of suicide: Protocol for a multi-site type 1 hybrid effectiveness-implementation trial. Contemp Clin Trials. 2026 Aug 15:108433. doi: 10.1016/j.cct.2026.108433. Online ahead of print.
PubMed 42603614
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans With PTSD at Elevated Acute Risk for Suicide
- ClinicalTrials.gov ID
- NCT05974631
- Acronym / sponsor ID
- SDR 22-185
- Keywords
- Stress Disorders, Post-Traumatic, Suicide, Self-Injurious Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posttraumatic Stress Disorder (PTSD) is a significant driver of suicide risk among Veterans, but there is a critical knowledge gap about how to treat PTSD among people at elevated risk for suicide. Although evidence-based treatments for PTSD reduce suicide risk, Veterans at high risk for suicidal behavior rarely receive these potentially life-saving treatments. Prior research suggests that a treatment that combines Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure protocol (DBT PE) for PTSD improves both PTSD and suicide-related outcomes. This study will evaluate whether DBT + DBT PE improves these outcomes more than Prolonged Exposure plus suicide risk management, the gold standard VA care for this population. The proposed study will also examine factors that make it easier and harder to implement these treatments in VA settings. The results will help to inform treatment guidelines for this high-priority Veteran population.
Detailed description
Background: Posttraumatic stress disorder (PTSD) is a significant risk factor for suicide among Veterans. Evidence-based psychotherapies (EBPs) for PTSD reduce suicide risk, but Veterans at elevated acute risk for suicide, such as those who have engaged in self-directed violence (SDV), rarely receive these treatments. This is largely due to the historical exclusion of high-risk individuals from PTSD treatment trials, which has resulted in a lack of evidence-based guidance about indicated treatments for this population. Without such guidance, clinicians are often reluctant to use EBPs for PTSD with suicidal individuals. A treatment that combines Dialectical Behavior Therapy (DBT), a suicide-focused EBP, with the DBT Prolonged Exposure (DBT PE) protocol for PTSD has been developed for this high-risk population and shows promise in reducing both SDV and PTSD while being feasible, acceptable, and safe to deliver. However, a large-scale randomized controlled trial (RCT) is needed. This study will compare the effectiveness of DBT + DBT PE to the current VHA gold standard of care for this population, Prolonged Exposure therapy augmented with suicide risk management (PE + SRM), while also examining the potential for implementation of both interventions in VHA.
Significance: There is a critical gap in knowledge about how to treat PTSD among individuals at high risk for suicidal behavior. As a result, VA/DoD Clinical Practice Guidelines do not specify indicated treatment strategies for this population. Experts have recommended two approaches to facilitate the safe and effective use of EBPs for PTSD with individuals at elevated acute suicide risk, including combining these treatments with suicide-focused EBPs or augmenting them with suicide risk management strategies. This project will help to fill this critical gap by rigorously evaluating these two approaches among Veterans with SDV. The results will provide important information to inform guidelines about indicated treatments for this high-risk population.
Innovativeness: This will be the first large-scale RCT to evaluate treatments for PTSD among Veterans who have engaged in SDV, an HSR\&D high priority group. The DBT + DBT PE intervention is the first treatment designed to address both SDV and PTSD, and results will indicate if this novel treatment improves outcomes compared to the current VHA gold standard of care. To facilitate more rapid implementation of these findings into clinical practice, implementation barriers and facilitators for both treatments will also be evaluated.
Specific Aims: This study will randomize 125 Veterans with PTSD, recent and repeated SDV, current suicidal ideation, and emotion dysregulation to DBT + DBT PE (intervention) or PE + SRM (control). Aim 1 will test the hypothesis that DBT + DBT PE will be superior to PE + SRM in improving clinical outcomes and engagement in trauma-focused treatment. Exploratory analyses will examine Veteran characteristics that may predict better engagement and outcomes in DBT + DBT PE versus PE + SRM. Aim 2 will examine barriers and facilitators to implementation of both treatments.
Methods: This is a multi-site hybrid type 1 effectiveness-implementation trial. Veterans will be treated in outpatient settings at four VA sites and assessed at 5 points over 16 months. A mixed-methods approach will be used to evaluate barriers and facilitators to implementation, including conducting interviews with 45 key stakeholders (Veterans, providers, and leadership).
Primary Outcomes/Endpoints: Primary outcomes will be reductions in SDV episodes at 16-month follow-up and reductions in PTSD severity at post-treatment.
Implementation/Next Steps: This project will provide much-needed information about how to safely and effectively treat PTSD among Veterans at elevated acute risk for suicide. If one or both treatments are found effective, Aim 2 will provide vital information about how to maximize future implementation success. Future implementation activities would be coordinated with the investigators' national operational partners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| DBT + DBT PE | Experimental | Behavioral: Dialectical Behavior Therapy, Behavioral: Dialectical Behavior Therapy Prolonged Exposure protocolThis condition combines one year of standard Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure (DBT PE) protocol for PTSD. |
| PE + SRM | Active comparator | Behavioral: Prolonged Exposure therapy, Behavioral: Suicide risk managementThis condition provides up to 18 sessions of Prolonged Exposure therapy (PE) for PTSD augmented with suicide risk management (SRM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PTSD
- Recent and repeated self-directed violence
- Current suicidal ideation
- Emotion dysregulation
- Veteran eligible for VHA mental health care at participating site
Key exclusion criteria (4 listed)
- Unable to maintain safety independently
- Currently engaged in and/or recent (past year) history of receiving a sufficient dose of DBT or PE
- Plan to move away or be unavailable for >4 weeks in the next 18 months
- Unable to sufficiently comprehend study procedures due to lack of English proficiency or moderate to severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavior TherapyAlso: DBTStandard Dialectical Behavior Therapy (DBT), including DBT individual therapy (1 hour/week), DBT group skills training (2 hours/week), between-session coaching (as needed during business hours), and therapist consultation team (1-1.5 hours/week). | Behavioural | DBT + DBT PE |
| Dialectical Behavior Therapy Prolonged Exposure protocolAlso: DBT PEDBT PE is designed to be integrated into DBT to formally treat PTSD once patients meet standardized readiness criteria. The core procedures are in vivo and imaginal exposure with processing that are delivered in individual therapy sessions (1.5 hours/week). | Behavioural | DBT + DBT PE |
| Prolonged Exposure therapyAlso: PEStandard PE is delivered in individual therapy sessions (1.5 hours/week) and uses the core procedures of in vivo and imaginal exposure with processing. | Behavioural | PE + SRM |
| Suicide risk managementAlso: SRMStandard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning. | Behavioural | PE + SRM |
Primary outcome
Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)
Time frame: Baseline to 16 months
Number of self-directed violence episodes
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Time frame: Baseline to 16 months
Total Severity Score (range = 0 - 200, higher is worse)
6 secondary outcomes
Columbia - Suicide Severity Rating Scale (C-SSRS), Suicide Ideation subscales
Time frame: Baseline to 16 months
PROMIS Global Mental Health
Time frame: Baseline to 16 months
Difficulties in Emotion Regulation Scale-16 (DERS-16)
Time frame: Baseline to 16 months
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline to 16 months
Self-Injurious Thoughts and Behaviors Interview Revised Short Form (SITBI-R-SF)
Time frame: Baseline to 16 months
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Time frame: Baseline to 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Derived from this study: PubMed 42603614Harned MS, Ready CB, Andrews Wiebusch LM, Landes SJ, Blalock DV, Waddell ZE, Carter JM, Hembree EA, Meis LA. Evaluating psychotherapies for veterans with PTSD at elevated acute risk of suicide: Protocol for a multi-site type 1 hybrid effectiveness-implementation trial. Contemp Clin Trials. 2026 Aug 15:108433. doi: 10.1016/j.cct.2026.108433. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified, anonymized data that underlie results in a publication may be shared.
Related trials for Self-directed Violence
Recruiting
Randomized Clinical Trial of Re-Evaluating Suicidal Thoughts in Veterans
Suicidal Ideation, Suicide, Attempted
Enrolling by invitation
Core Competency Model for Corrections
Knowledge, Attitudes, Practice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie S Harned, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavior Therapy, Dialectical Behavior Therapy Prolonged Exposure protocol and Prolonged Exposure therapy in people with Self-directed Violence and Post-traumatic Stress Disorder (PTSD), run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie S Harned, PhD ((206) 277-3650, melanie.harned@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF) (time frame: Baseline to 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05974631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.