Stress Disorders, Post-TraumaticSTART-PTSDNCT04515784
Safety Aid Reduction Treatment for PTSD Among Veterans
A study testing Safety Aid Reduction Treatment for PTSD in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this project is to examine the acceptability, feasibility, and utility of a safety aid reduction treatment (START) among Veterans with posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Safety Aid Reduction Treatment for PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Veterans receiving care at New Orleans VA
- Veterans with diagnosis of PTSD who decline trauma focused treatment
Who cannot join
- Substance dependence requiring detoxification
- Active psychosis
- Uncontrolled Bipolar Disorder
- Severe suicidal intent requiring hospitalization
- Current engagement in psychotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, 70119
About this study
Official title: Examination of a Safety Aid Reduction Protocol for Treatment Resistant PTSD Among Veterans
The purpose of this project is to examine the acceptability, feasibility, and utility of a safety aid reduction treatment (START) among Veterans with posttraumatic stress disorder (PTSD). It is hypothesized that START will be acceptable, feasible, and will lead to reductions in PTSD symptom severity immediately and over time.
Read the detailed description
Rates of posttraumatic stress disorder (PTSD) among military personnel have surged in recent years. In response, the Department of Veterans Affairs (VA) has launched nationwide training initiatives to disseminate two PTSD treatments with strong empirical support: prolonged exposure (PE) therapy and cognitive processing therapy (CPT). Despite the well-documented effectiveness of PE and CPT, only a minority of Veterans with PTSD initiate these trauma-focused treatments. One approach to addressing PTSD in a non-trauma-focused fashion is to utilize empirically supported treatments focused on safety aid reduction. Safety aids are maladaptive cognitive and/or behavioral strategies designed to prevent, avoid, or alleviate anxiety. Initially introduced as a way to explain how pathological anxiety can persist despite repeated exposure to feared stimuli, safety aids have been found to play a critical role in the etiology and maintenance of various anxiety and related conditions including PTSD. Importantly, a separate line of research suggests that safety aids are amenable to change through cognitive behavioral interventions. Although promising, these trials did not include patients with PTSD. In this context, the purpose of this project is to examine the acceptability, feasibility, and utility of a safety aid reduction treatment (START) for PTSD. Participants will include veterans with a diagnosis of PTSD who decline to participate in evidence-based psychotherapies (EBPs) for PTSD, namely PE or CPT. It is hypothesized that START will be acceptable, feasible, and will lead to reductions in PTSD symptom severity immediately and over time.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Safety Aid Reduction Treatment for PTSD
- Keywords
- Safety aid, Treatment, Posttraumatic Stress Disorder, Veteran
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Aid Reduction Treatment for PTSDBehavioural
START-PTSD includes many of the key elements found in empirically supported treatments for PTSD including: a) psychoeducation regarding the development and maintenance of PTSD; and b) exposure to internal sensations and external situations that are connected to one's fear/distress response via identification and elimination of safety aids. Known safety aids to be covered include: cognitive avoidance (e.g., using mental distractions to avoid trauma-related images); situational avoidance (e.g., avoiding crowded market places); checking behaviors (e.g., checking doors, windows, locks, and perimeters more often than necessary); reassurance seeking (e.g., excessively watching the news); other compulsive behaviors (e.g., checking the location of exits); use of companions (e.g., relying on someone to attend a social gathering); and use of alcohol and certain substances (e.g., consuming alcohol to reduce anxiety).
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Active arm- START-PTSD Receives: Behavioral: Safety Aid Reduction Treatment for PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Diagnostic Status as Measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is a 30-item clinician-administered interview designed to assess current (i.e., past month) and lifetime PTSD diagnostic status. In addition to assessing the 20 DSM-5 PTSD symptoms, the CAPS-5 contains questions regarding the onset and duration of symptoms, associated impairment in various life domains, and specifications for the dissociative subtype. The past month CAPS-5 will be administered at baseline and one-month follow-up to assess changes in PTSD diagnostic status. Totals scores range 0-80, where higher scores indicating higher symptom severity.
Measured: One-month follow-up
Change in PTSD Symptoms as Measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report questionnaire designed to assess each of the 20 DSM-5 PTSD symptoms. Veterans will be asked to read a list of symptoms and indicate their level of distress as it relates to each within the past month using a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (Extremely). Total scores can range from 0 to 80 with higher scores reflecting increased symptom severity. The PCL-5 will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in PTSD symptom severity.
Measured: Post-intervention (10-weeks) and one-month follow-up
Changes in Safety Aid Usage as Measured by the Safety Behavior Assessment Form (SBAF)
The SBAF is a 41-item self-report questionnaire designed to assess safety behavior usage. Veterans will be asked to read a list of behaviors and rate how often they engage in each behavior using a 4-point Likert-type scale ranging from 0 (Never) to 3 (Always). Total scores can range from 0 to 123 with higher scores reflecting increased symptom severity. The SBAF will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in safety behavior usage.
Measured: Post-intervention (10-weeks) and one-month follow-up
Client Satisfaction Questionnaire-8 (CSQ-8)
The CSQ-8 is an 8-item self-report questionnaire designed to assess overall satisfaction with treatment services. Although response options differ from item-to-item, all questions are rated on a 4-point Likert-type scale ranging from 1 to 4 (total scores ranging 8 - 32) with higher scores indicating higher treatment satisfaction. The CSQ-8 will be administered immediately following the 10-week group to assess treatment acceptability.
Measured: Post-intervention (10-weeks)
Secondary outcomes (4)
Changes in Anxiety as Measured by the Beck Anxiety Inventory (BAI)
The BAI is a 21-item self-report questionnaire designed to assess the experience of anxiety symptoms. Veterans will be asked to rate how often they experience each symptom using a 4-point Likert-type scale ranging from 0 (Not at all) to 3 (Severely). Total scores can range from 0 to 63 with higher scores reflecting increased symptom severity. The BAI will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in anxiety symptoms.
Measured: Post-intervention (10-weeks) and one-month follow-up
Changes in Depression as Measured by the Beck Depression Inventory-II (BDI-II)
The BDI-II is a 21-item self-report questionnaire designed to assess symptoms associated with depression. Using a 4-point Likert-type scale ranging from 0 to 3, Veterans will be asked to select the statement from a group of statements that best represents how they have felt over the last two weeks. Total scores can range from 0 to 63 with higher scores reflecting increased symptom severity. The BDI-II will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in depression symptoms.
Measured: Post-intervention (10-weeks) and one-month follow-up
Changes in PTSD Cognitions as Measured by the Posttraumatic Cognitions Inventory (PTCI)
The PTCI is a 33-item self-report questionnaire designed to assess trauma-related thoughts and beliefs including negative cognitions regarding the self, others, and the world. Veterans will be asked to read a list of statements and indicate the degree to which they agree or disagree with each statement using a 7-point Likert-type scale ranging from 1(totally disagree) to 7 (totally agree). Total scores can range from 33 to 231 with higher scores reflecting increased symptom severity. The PTCI will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in PTSD cognitions.
Measured: Post-intervention (10-weeks) and one-month follow-up
Changes in Funtional Impairment as Measured by the Sheehan Disability Scale (SDS)
The SDS is a 3-item self-report questionnaire designed to assess functional impairment functional impairment in work/school, social, and family life. For each domain, Veterans will be asked to provide an impairment rating ranging from 0 (Not at all) to 10 (Extremely). Total scores can range from 0 to 30 with higher scores reflecting increased impairment. The SDS will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in functional impairment.
Measured: Post-intervention (10-weeks) and one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start7 Aug 2023
- Primary completion29 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- One-arm trial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amanda M Raines, PhD, Principal investigator, Southeast Louisiana Veterans Health Care System, New Orleans, LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515784
- Sponsor's protocol ID
- MHBP-003-19F
- Other IDs
- 5IK2CX001978-02
- Acronym
- START-PTSD
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2020
- Last updated
- 9 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to disclose data outside of the VA, however, if there is a need to disclose data outside of the VA (e.g., a member of the scientific community requests a copy), IRB approval will be sought, data will be de-identified prior to disclosing, and the disclosure will be recorded on a VA disclosure log as required by VA policy.
Publications
Rosen CS, Bernardy NC, Chard KM, Clothier B, Cook JM, Crowley J, Eftekhari A, Kehle-Forbes SM, Mohr DC, Noorbaloochi S, Orazem RJ, Ruzek JI, Schnurr PP, Smith BN, Sayer NA. Which patients initiate cognitive processing therapy and prolonged exposure in department of veterans affairs PTSD clinics? J Anxiety Disord. 2019 Mar;62:53-60. doi: 10.1016/j.janxdis.2018.11.003. Epub 2018 Nov 20.
PubMed 30550959Powers MB, Halpern JM, Ferenschak MP, Gillihan SJ, Foa EB. A meta-analytic review of prolonged exposure for posttraumatic stress disorder. Clin Psychol Rev. 2010 Aug;30(6):635-41. doi: 10.1016/j.cpr.2010.04.007. Epub 2010 May 2.
PubMed 20546985Dunmore E, Clark DM, Ehlers A. Cognitive factors involved in the onset and maintenance of posttraumatic stress disorder (PTSD) after physical or sexual assault. Behav Res Ther. 1999 Sep;37(9):809-29. doi: 10.1016/s0005-7967(98)00181-8.
PubMed 10458046Riccardi CJ, Korte KJ, Schmidt NB. False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. J Anxiety Disord. 2017 Mar;46:35-45. doi: 10.1016/j.janxdis.2016.06.003. Epub 2016 Jun 18.
PubMed 27397584Schmidt NB, Buckner JD, Pusser A, Woolaway-Bickel K, Preston JL, Norr A. Randomized controlled trial of false safety behavior elimination therapy: a unified cognitive behavioral treatment for anxiety psychopathology. Behav Ther. 2012 Sep;43(3):518-32. doi: 10.1016/j.beth.2012.02.004. Epub 2012 Mar 9.
PubMed 22697441Monson CM, Schnurr PP, Resick PA, Friedman MJ, Young-Xu Y, Stevens SP. Cognitive processing therapy for veterans with military-related posttraumatic stress disorder. J Consult Clin Psychol. 2006 Oct;74(5):898-907. doi: 10.1037/0022-006X.74.5.898.
PubMed 17032094Fulton JJ, Calhoun PS, Wagner HR, Schry AR, Hair LP, Feeling N, Elbogen E, Beckham JC. The prevalence of posttraumatic stress disorder in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans: a meta-analysis. J Anxiety Disord. 2015 Apr;31:98-107. doi: 10.1016/j.janxdis.2015.02.003. Epub 2015 Feb 19.
PubMed 25768399
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of a Safety Aid Reduction Protocol for Treatment Resistant PTSD Among Veterans
- ClinicalTrials.gov ID
- NCT04515784
- Acronym / sponsor ID
- START-PTSD / MHBP-003-19F
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Safety aid, Treatment, Posttraumatic Stress Disorder, Veteran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Posted 9 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to examine the acceptability, feasibility, and utility of a safety aid reduction treatment (START) among Veterans with posttraumatic stress disorder (PTSD). It is hypothesized that START will be acceptable, feasible, and will lead to reductions in PTSD symptom severity immediately and over time.
Detailed description
Rates of posttraumatic stress disorder (PTSD) among military personnel have surged in recent years. In response, the Department of Veterans Affairs (VA) has launched nationwide training initiatives to disseminate two PTSD treatments with strong empirical support: prolonged exposure (PE) therapy and cognitive processing therapy (CPT). Despite the well-documented effectiveness of PE and CPT, only a minority of Veterans with PTSD initiate these trauma-focused treatments. One approach to addressing PTSD in a non-trauma-focused fashion is to utilize empirically supported treatments focused on safety aid reduction. Safety aids are maladaptive cognitive and/or behavioral strategies designed to prevent, avoid, or alleviate anxiety. Initially introduced as a way to explain how pathological anxiety can persist despite repeated exposure to feared stimuli, safety aids have been found to play a critical role in the etiology and maintenance of various anxiety and related conditions including PTSD. Importantly, a separate line of research suggests that safety aids are amenable to change through cognitive behavioral interventions. Although promising, these trials did not include patients with PTSD. In this context, the purpose of this project is to examine the acceptability, feasibility, and utility of a safety aid reduction treatment (START) for PTSD. Participants will include veterans with a diagnosis of PTSD who decline to participate in evidence-based psychotherapies (EBPs) for PTSD, namely PE or CPT. It is hypothesized that START will be acceptable, feasible, and will lead to reductions in PTSD symptom severity immediately and over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One-arm trial
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Behavioral: Safety Aid Reduction Treatment for PTSDActive arm- START-PTSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans receiving care at New Orleans VA
- Veterans with diagnosis of PTSD who decline trauma focused treatment
Key exclusion criteria (5 listed)
- Substance dependence requiring detoxification
- Active psychosis
- Uncontrolled Bipolar Disorder
- Severe suicidal intent requiring hospitalization
- Current engagement in psychotherapy
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 |
|---|---|---|
| Safety Aid Reduction Treatment for PTSDSTART-PTSD includes many of the key elements found in empirically supported treatments for PTSD including: a) psychoeducation regarding the development and maintenance of PTSD; and b) exposure to internal sensations and external situations that are connected to one's fear/distress response via identification and elimination of safety aids. Known safety aids to be covered include: cognitive avoidance (e.g., using mental distractions to avoid trauma-related images); situational avoidance (e.g., avoiding crowded market places); checking behaviors (e.g., checking doors, windows, locks, and perimeters more often than necessary); reassurance seeking (e.g., excessively watching the news); other compulsive behaviors (e.g., checking the location of exits); use of companions (e.g., relying on someone to attend a social gathering); and use of alcohol and certain substances (e.g., consuming alcohol to reduce anxiety). | Behavioural | Active |
Primary outcome
Change in PTSD Diagnostic Status as Measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: One-month follow-up
The CAPS-5 is a 30-item clinician-administered interview designed to assess current (i.e., past month) and lifetime PTSD diagnostic status. In addition to assessing the 20 DSM-5 PTSD symptoms, the CAPS-5 contains questions regarding the onset and duration of symptoms, associated impairment in various life domains, and specifications for the dissociative subtype. The past month CAPS-5 will be administered at baseline and one-month follow-up to assess changes in PTSD diagnostic status. Totals scores range 0-80, where higher scores indicating higher symptom severity.
Change in PTSD Symptoms as Measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: Post-intervention (10-weeks) and one-month follow-up
The PCL-5 is a 20-item self-report questionnaire designed to assess each of the 20 DSM-5 PTSD symptoms. Veterans will be asked to read a list of symptoms and indicate their level of distress as it relates to each within the past month using a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (Extremely). Total scores can range from 0 to 80 with higher scores reflecting increased symptom severity. The PCL-5 will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in PTSD symptom severity.
Changes in Safety Aid Usage as Measured by the Safety Behavior Assessment Form (SBAF)
Time frame: Post-intervention (10-weeks) and one-month follow-up
The SBAF is a 41-item self-report questionnaire designed to assess safety behavior usage. Veterans will be asked to read a list of behaviors and rate how often they engage in each behavior using a 4-point Likert-type scale ranging from 0 (Never) to 3 (Always). Total scores can range from 0 to 123 with higher scores reflecting increased symptom severity. The SBAF will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in safety behavior usage.
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: Post-intervention (10-weeks)
The CSQ-8 is an 8-item self-report questionnaire designed to assess overall satisfaction with treatment services. Although response options differ from item-to-item, all questions are rated on a 4-point Likert-type scale ranging from 1 to 4 (total scores ranging 8 - 32) with higher scores indicating higher treatment satisfaction. The CSQ-8 will be administered immediately following the 10-week group to assess treatment acceptability.
4 secondary outcomes
Changes in Anxiety as Measured by the Beck Anxiety Inventory (BAI)
Time frame: Post-intervention (10-weeks) and one-month follow-up
Changes in Depression as Measured by the Beck Depression Inventory-II (BDI-II)
Time frame: Post-intervention (10-weeks) and one-month follow-up
Changes in PTSD Cognitions as Measured by the Posttraumatic Cognitions Inventory (PTCI)
Time frame: Post-intervention (10-weeks) and one-month follow-up
Changes in Funtional Impairment as Measured by the Sheehan Disability Scale (SDS)
Time frame: Post-intervention (10-weeks) and one-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30550959Rosen CS, Bernardy NC, Chard KM, Clothier B, Cook JM, Crowley J, Eftekhari A, Kehle-Forbes SM, Mohr DC, Noorbaloochi S, Orazem RJ, Ruzek JI, Schnurr PP, Smith BN, Sayer NA. Which patients initiate cognitive processing therapy and prolonged exposure in department of veterans affairs PTSD clinics? J Anxiety Disord. 2019 Mar;62:53-60. doi: 10.1016/j.janxdis.2018.11.003. Epub 2018 Nov 20.
- Background: PubMed 20546985Powers MB, Halpern JM, Ferenschak MP, Gillihan SJ, Foa EB. A meta-analytic review of prolonged exposure for posttraumatic stress disorder. Clin Psychol Rev. 2010 Aug;30(6):635-41. doi: 10.1016/j.cpr.2010.04.007. Epub 2010 May 2.
- Background: PubMed 10458046Dunmore E, Clark DM, Ehlers A. Cognitive factors involved in the onset and maintenance of posttraumatic stress disorder (PTSD) after physical or sexual assault. Behav Res Ther. 1999 Sep;37(9):809-29. doi: 10.1016/s0005-7967(98)00181-8.
- Background: PubMed 27397584Riccardi CJ, Korte KJ, Schmidt NB. False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. J Anxiety Disord. 2017 Mar;46:35-45. doi: 10.1016/j.janxdis.2016.06.003. Epub 2016 Jun 18.
- Background: PubMed 22697441Schmidt NB, Buckner JD, Pusser A, Woolaway-Bickel K, Preston JL, Norr A. Randomized controlled trial of false safety behavior elimination therapy: a unified cognitive behavioral treatment for anxiety psychopathology. Behav Ther. 2012 Sep;43(3):518-32. doi: 10.1016/j.beth.2012.02.004. Epub 2012 Mar 9.
- Background: PubMed 17032094Monson CM, Schnurr PP, Resick PA, Friedman MJ, Young-Xu Y, Stevens SP. Cognitive processing therapy for veterans with military-related posttraumatic stress disorder. J Consult Clin Psychol. 2006 Oct;74(5):898-907. doi: 10.1037/0022-006X.74.5.898.
- Background: PubMed 25768399Fulton JJ, Calhoun PS, Wagner HR, Schry AR, Hair LP, Feeling N, Elbogen E, Beckham JC. The prevalence of posttraumatic stress disorder in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans: a meta-analysis. J Anxiety Disord. 2015 Apr;31:98-107. doi: 10.1016/j.janxdis.2015.02.003. Epub 2015 Feb 19.
- Individual participant dataSharing planned: No. There are no plans to disclose data outside of the VA, however, if there is a need to disclose data outside of the VA (e.g., a member of the scientific community requests a copy), IRB approval will be sought, data will be de-identified prior to disclosing, and the disclosure will be recorded on a VA disclosure log as required by VA policy.
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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. This study is not recruiting at the moment.
Amanda M Raines, PhD principal investigator
Southeast Louisiana Veterans Health Care System, New Orleans, LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Aid Reduction Treatment for PTSD in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Diagnostic Status as Measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: One-month follow-up). The study lists 4 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 NCT04515784, which also lists 7 linked publications.
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 9 Oct 2026.