START for Post-Traumatic Stress Disorder

(START-PTSD Trial)

Overseen by Amanda M Raines, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Substance dependence, Active psychosis, Bipolar, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment called START, which helps veterans with PTSD reduce their reliance on anxiety-avoiding behaviors. It targets veterans who avoid traditional PTSD therapies. By reducing these 'safety aids,' the treatment aims to help them face their fears and feel less anxious over time.

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 data supports the effectiveness of the Safety Aid Reduction Treatment (START) for PTSD?

The Seeking Safety treatment, which is similar to START, has shown significant improvements in PTSD symptoms and substance use in various studies, including a pilot study at Walter Reed National Military Medical Center. Additionally, Seeking Safety is a flexible therapy that has been effective in treating PTSD and substance use disorder together, which suggests potential benefits for START in similar contexts. ^{1 2 3 4 5}

What safety data exists for the START treatment for PTSD?

The research highlights that safety data in psychotherapy trials, including those for PTSD, often lack standardization in assessing harm. While serious adverse events like hospitalizations are monitored, other potential side effects, such as temporary increases in anxiety, are not consistently documented. ^{6 7 8 9 10}

How is the Safety Aid Reduction Treatment (START) for PTSD different from other treatments?

The Safety Aid Reduction Treatment (START) for PTSD is unique because it focuses on reducing reliance on safety behaviors, which are actions people take to feel safe but can actually maintain anxiety. This approach is different from other treatments like Seeking Safety, which integrates coping skills and psychoeducation for PTSD and substance use disorders. ^{1 3 4 11 12}

Research Team

Amanda M Raines, PhD

Principal Investigator

Southeast Louisiana Veterans Health Care System, New Orleans, LA

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Safety Aid Reduction Treatment for PTSD (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Seeking safety intervention for comorbid post-traumatic stress and substance use disorder: A meta-analysis. [2023]

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Seeking Safety Pilot Outcome Study at Walter Reed National Military Medical Center. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Critical incident stress debriefing after adverse patient safety events. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Does seeking safety reduce PTSD symptoms in women receiving physical disability compensation? [2014]

12. United States 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. [2020]