START for Post-Traumatic Stress Disorder

(START-PTSD Trial)

Overseen By Amanda M Raines, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance dependence, Active psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Safety Aid Reduction Treatment (START) to help Veterans with post-traumatic stress disorder (PTSD). The goal is to determine if this treatment is easy to use and effective in reducing PTSD symptoms over time. Veterans receiving care at the New Orleans VA who have PTSD and prefer not to engage in trauma-focused therapy might be suitable candidates for this trial. However, those with other serious mental health issues or who are currently in therapy may not qualify. As an unphased trial, this study provides Veterans the chance to explore a novel treatment option for PTSD symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this Safety Aid Reduction Treatment is safe for Veterans with PTSD?

Research shows that the Safety Aid Reduction Treatment (START) for PTSD is generally well-received by veterans. In previous studies, most veterans found the treatment helpful and acceptable, indicating that it is both practical and manageable for participants.

Specific information on side effects is not available, but positive feedback and high retention rates suggest that START is likely safe. This treatment aims to reduce PTSD symptoms, and veterans have reported finding it beneficial without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for PTSD, like therapy and medications such as SSRIs or SNRIs, aim to manage symptoms over time. However, Safety Aid Reduction Treatment for PTSD (START-PTSD) stands out because it targets the reliance on safety behaviors that can maintain anxiety. By focusing on reducing these safety behaviors, START-PTSD helps individuals confront and process traumatic memories more effectively. Researchers are excited about this approach because it could lead to more rapid and lasting improvements in PTSD symptoms compared to existing options.

What evidence suggests that the Safety Aid Reduction Treatment is effective for PTSD?

Research has shown that the Safety Aid Reduction Treatment (START), which participants in this trial will receive, may help reduce PTSD symptoms in veterans. Previous studies found that most veterans considered START helpful and acceptable. Recruitment and retention data suggest that participants could easily continue with this treatment. Another study on a similar treatment showed it significantly reduced post-traumatic stress symptoms. These findings suggest that START could be a promising option for those dealing with PTSD. ^{1 2 4 5 6}

Who Is on the Research Team?

Amanda M Raines, PhD

Principal Investigator

Southeast Louisiana Veterans Health Care System, New Orleans, LA

Are You a Good Fit for This Trial?

This trial is for Veterans at the New Orleans VA with PTSD who are not currently in psychotherapy and have declined trauma-focused treatment. It's not open to those with severe suicidal intent, active psychosis, substance dependence needing detox, or uncontrolled Bipolar Disorder.

Inclusion Criteria

I am a veteran with PTSD and I choose not to undergo trauma-focused treatment.

Veterans receiving care at New Orleans VA

Exclusion Criteria

You are currently experiencing a severe mental disorder that affects your thoughts, emotions, and behavior.

My bipolar disorder is not under control.

Severe suicidal intent requiring hospitalization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Safety Aid Reduction Treatment (START) for PTSD over a 10-week period

10 weeks

Weekly group sessions

Follow-up

Participants are monitored for changes in PTSD symptoms, safety aid usage, and other psychological measures

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Safety Aid Reduction Treatment for PTSD

Trial Overview

The study tests a new approach called START for reducing PTSD symptoms against a wait-list control group. Participants will be randomly assigned to either receive the START treatment immediately or placed on a waiting list.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Active arm- START-PTSD

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study involving 343 women with co-occurring PTSD and substance use disorders, the integrated treatment Seeking Safety plus treatment as usual (TAU) did not show superior efficacy in reducing PTSD severity compared to TAU alone, but it did improve outcomes related to depression and emotion regulation.

Relapse Prevention Training (RPT) plus TAU was more effective than TAU alone in increasing the number of substance-free days and reducing alcohol severity, indicating that while neither integrated treatment was superior for PTSD, they both offered benefits in other areas of mental health and substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multisite randomized controlled trial of Seeking Safety vs. Relapse Prevention Training for women with co-occurring posttraumatic stress disorder and substance use disorders. Schäfer, I., Lotzin, A., Hiller, P., et al.[2020]

In a study of 420 veterans with PTSD, those receiving Seeking Safety (SS) had a higher treatment completion rate (89%) compared to those receiving cognitive processing therapy (CPT) (50%), indicating SS may be more acceptable for veterans.

However, veterans who completed CPT showed significantly greater reductions in PTSD symptoms, as measured by the PTSD checklist, suggesting that while SS is easier to complete, CPT may be more effective in reducing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. Baig, MR., Ouyang, S., Mata-Galán, E., et al.[2021]

The study aims to evaluate the efficacy of the Seeking Safety program, an integrated treatment for PTSD and substance use disorder (SUD), in a Dutch outpatient population through a randomized controlled trial involving 12 group sessions.

It is expected that participants receiving Seeking Safety will show greater improvements in substance use severity and lower drop-out rates compared to those receiving Cognitive Behavioral Therapy (CBT), with assessments conducted at the start, end, and six months after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial. Kok, T., de Haan, HA., van der Meer, M., et al.[2021]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

Adverse events (AEs) in healthcare are common, occurring in about 10% of cases, and can have significant emotional impacts not only on patients but also on the healthcare professionals involved, who may experience trauma as 'second victims'.

Implementing Critical Incident Stress Debriefing (CISD) for healthcare staff after AEs could be a valuable strategy to support their resilience and recovery, similar to its use in other high-stress professions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical incident stress debriefing after adverse patient safety events. Harrison, R., Wu, A.[2018]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

In a study of 353 women with PTSD and substance use disorder, those with physical disabilities showed significant and sustained reductions in PTSD symptoms after 12 sessions of Seeking Safety therapy, unlike those in the Women's Health Education group who returned to baseline levels by 12 months.

The findings highlight the effectiveness of Seeking Safety as a targeted treatment for PTSD in women with physical disabilities, emphasizing the need for specialized approaches to address trauma in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does seeking safety reduce PTSD symptoms in women receiving physical disability compensation? Anderson, ML., Najavits, LM.[2014]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

An intensive outpatient program (IOP) for PTSD, offering Prolonged Exposure and Cognitive Processing Therapy three or more times a week, achieved a high completion rate of 87.3% among veterans, indicating strong acceptability.

The IOP demonstrated significant effectiveness, with a large effect size (d = 1.80) in reducing PTSD symptoms, suggesting it is a promising treatment option to enhance engagement and outcomes in PTSD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. Yamokoski, C., Flores, H., Facemire, V., et al.[2023]

The meta-analysis of seven randomized control trials indicates that Seeking Safety (SS) is effective in reducing PTSD symptoms more significantly than substance use, with medium to large effect sizes observed at various follow-up points, particularly at 6 and 9 months.

Partial dose versions of SS are nearly as effective as the full dose in achieving long-term benefits, suggesting flexibility in treatment delivery without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeking safety intervention for comorbid post-traumatic stress and substance use disorder: A meta-analysis. Sherman, ADF., Balthazar, M., Zhang, W., et al.[2023]

A pilot trial of the Seeking Safety (SS) therapy involving 24 military service members showed significant improvements in PTSD symptoms and substance use, indicating its effectiveness for treating these comorbid conditions.

Participants reported high satisfaction with the SS therapy, suggesting it is a feasible intervention for military personnel dealing with PTSD and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeking Safety Pilot Outcome Study at Walter Reed National Military Medical Center. Najavits, LM., Lande, RG., Gragnani, C., et al.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04515784

Safety Aid Reduction Treatment for PTSD Among Veterans

It is hypothesized that START will be acceptable, feasible, and will lead to reductions in PTSD symptom severity immediately and over time. Detailed Description.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10482000/

Acceptability, feasibility, and utility of a safety aid reduction ...

The majority of veterans found START useful and acceptable. Additionally, recruitment and retention rates suggest that the treatment was feasible. Notably, ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032723008388

Efficacy of a novel safety behavior elimination intervention ...

Results suggest that SBETS has a significant effect on PTSS, and may represent an acceptable, accessible treatment option for trauma survivors.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10529664/

Efficacy of a Novel Safety Behavior Elimination Intervention ...

Efficacy of a novel safety behavior elimination intervention for posttraumatic stress symptoms: results from a randomized controlled trial.

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/17437199.2025.2526666

Efficacy of interventions for posttraumatic stress disorder ...

Although outcome data for groups were not reported, individuals had significantly greater symptom reduction in the TMS and TMS + BE than sham treatment ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2468749925000894

Associations between safety aid usage and posttraumatic ...

Results revealed moderate to strong associations between safety aid usage and self-reported PTSD symptoms (rs = .56-.72) and small to moderate ...