Brief Exposure Therapy for PTSD

(PTSD Trial)

Overseen By Bradley S Peterson, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Substance dependence, Psychotic disorders, Bipolar, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is developing a new behavioral treatment for U.S. combat veterans with PTSD. It examines how brief exposure to combat-related images affects brain activity and feelings of fear. Participants will view both quick and clear images during a brain scan and report their feelings about fear and awareness. Combat veterans with PTSD who have experienced trauma, such as injury or loss, may find this study suitable. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could shape future PTSD treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been treated for PTSD, substance abuse, or mental health concerns in the past 6 months, you may not be eligible to participate.

What prior data suggests that this behavioral treatment is safe for U.S. combat veterans with PTSD?

Studies have shown that exposure therapy is generally safe for people with PTSD. Research indicates that most patients can handle this treatment without major problems. For example, a study that combined results from multiple studies involving 387 people found that exposure therapy improved PTSD symptoms compared to no treatment.

While the specific Very Brief Exposure treatment in this trial is newer, similar exposure therapies have been well-tolerated. Severe side effects are uncommon. Some may feel discomfort or increased anxiety during sessions, but this is considered part of the therapy process and is usually temporary.

Overall, previous research points to exposure therapy as a safe option for managing PTSD. This data should encourage participants considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brief Exposure Therapy for PTSD because it offers a unique approach by using very brief exposure (VBE) to specific stimuli. Unlike traditional therapies, which often require extended sessions over several weeks, this method allows for rapid exposure to combat images and everyday scenes within a controlled fMRI environment. The potential for quick results and the ability to measure brain activity in real time make this approach particularly promising for understanding and treating PTSD more effectively.

What evidence suggests that Very Brief Exposure Therapy might be an effective treatment for PTSD?

Research shows that exposure therapies can help treat PTSD. Studies have found that Written Exposure Therapy (WET), similar to other methods, works as well as traditional treatments like Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) in reducing PTSD symptoms. This therapy is effective for individuals with complex PTSD and other mental health issues. Additionally, exposure therapies often lead to quicker symptom relief and better treatment adherence, meaning participants are more likely to continue with the treatment. Overall, these findings suggest that Very Brief Exposure, which participants in this trial will experience, could be a promising way to manage PTSD symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Bradley S. Peterson, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for U.S. combat veterans who have PTSD. Participants will be exposed to combat-related images and must be able to undergo an fMRI scan. The study aims to include those directly affected by traumatic stress disorders, specifically from their military service.

Inclusion Criteria

Patient Population: Traumatic event is a combat-based experience (e.g., being injured, watching a buddy be killed)

Patient Population: Minimum score of 18 on the Combat Experience Scale (CES)

Patient Population: Minimum score of 3 or more on Primary Care (PC)-PTSD-5

Exclusion Criteria

Patient Population: Acute intoxication

Patient Population: Severe level of Substance Dependence (6 or more DSM-V symptoms)

Patient Population: Dementia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Very Brief Exposure (VBE) and visible exposure to combat stimuli during fMRI scanning

1 week

Multiple sessions during the week

Follow-up

Participants are monitored for changes in brain activity and fear responses after exposure

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Very Brief Exposure

Trial Overview

The trial tests a new behavioral treatment involving very brief exposure to combat images compared with visible exposure, assessing its effects on brain activity and subjective fear ratings in participants with PTSD versus healthy controls.

How Is the Trial Designed?

Group I: Image Exposure Arm Experimental Treatment 1 Intervention

This within-subjects design study will have all participants view three types of exposure during fMRI scanning: VBE to combat images, VBE to masked everyday scenes (control), and conscious visible exposure to the same images (control).

Very Brief Exposure is already approved in United States for the following indications:

Approved in United States as Very Brief Exposure Therapy for:

• Post-traumatic stress disorder (PTSD)

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

In a study of 231 Veterans undergoing an 8-week modified prolonged exposure therapy for PTSD, most participants (n = 190) did not respond positively to the treatment, indicating that this modified approach may not be effective for many individuals.

The only significant predictor of treatment success was baseline anxiety levels, with nonresponders showing higher anxiety symptoms and lower social support compared to responders, suggesting that those with higher anxiety may need different treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and Outcomes of Growth Mixture Modeled Trajectories Across an Exposure-Based PTSD Intervention With Veterans. Allan, NP., Gros, DF., Myers, US., et al.[2019]

A study involving 130 adults with PTSD found that adding 10 minutes of aerobic exercise to exposure therapy significantly reduced PTSD severity compared to exposure therapy with passive stretching, with a moderate effect size of 0.6 after 6 months.

No adverse events were reported, suggesting that brief aerobic exercise is a safe and effective way to enhance the benefits of exposure therapy for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmenting trauma-focused psychotherapy for post-traumatic stress disorder with brief aerobic exercise in Australia: a randomised clinical trial. Bryant, RA., Dawson, KS., Azevedo, S., et al.[2022]

Written exposure therapy, a brief 5-session intervention, was found to be noninferior to the more intensive cognitive processing therapy in treating PTSD among military service members, indicating it can be an effective alternative.

The study involved 169 active-duty military participants, with a high completion rate of 76.5% for written exposure therapy, suggesting it may be a more efficient treatment option with lower dropout rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. Sloan, DM., Marx, BP., Resick, PA., et al.[2022]

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 female assault survivors with PTSD undergoing prolonged exposure therapy, 52% experienced sudden gains, which were significant rapid improvements in their symptoms.

These sudden gains averaged 12.4 points and accounted for 61% of the overall symptom reduction, suggesting that recognizing and understanding these gains could enhance treatment engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary investigation of sudden gains in exposure therapy for PTSD. Doane, LS., Feeny, NC., Zoellner, LA.[2021]

Written Exposure Therapy (WET) significantly reduced PTSD symptoms (effect size d = .84), depression symptoms (d = .47), and functional impairment (d = .36) in a study involving 277 veterans, demonstrating its effectiveness in a clinical setting.

The treatment was effective regardless of whether it was delivered in-person or via telehealth, with telehealth showing a lower dropout rate, suggesting it may be a more accessible option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of written exposure therapy for posttraumatic stress disorder in the Department of Veterans Affairs Healthcare System. LoSavio, ST., Worley, CB., Aajmain, ST., et al.[2023]

Trauma-focused cognitive-behavioral therapies (CBT) show medium to large effects in treating PTSD in individuals facing ongoing threats, based on a review of 21 studies involving various types of trauma exposure.

However, the safety and long-term effectiveness of these treatments for individuals under ongoing threat remain uncertain, highlighting the need for further research on potential adverse effects and treatment adaptations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapies for posttraumatic stress disorder under ongoing threat: A systematic review. Ennis, N., Sijercic, I., Monson, CM.[2021]

Exposure therapy is a safe and effective treatment for Posttraumatic Stress Disorder (PTSD), supported by strong evidence from well-controlled studies across various trauma populations.

Despite its effectiveness, misconceptions about exposure therapy may hinder its broader acceptance, highlighting the importance of proper application by experienced therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure therapy for posttraumatic stress disorder. Rothbaum, BO., Schwartz, AC.[2018]

Written exposure therapy (WET) was found to be noninferior to prolonged exposure therapy (PE) in reducing PTSD symptoms among 178 veterans, demonstrating similar effectiveness with fewer sessions required.

Participants in the WET group had significantly lower dropout rates (12.5%) compared to those in the PE group (35.6%), suggesting that WET may be a more accessible treatment option for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. Sloan, DM., Marx, BP., Acierno, R., et al.[2023]

A systematic review of 85 randomized controlled trials involving 14,420 participants found that adverse events (AEs) from psychotherapy can affect more than 10% of participants, with serious AEs occurring in more than 1 in 21 participants.

The study highlighted that the reporting and recording of AEs were inconsistent across trials, suggesting a need for standardized harm monitoring to better evaluate the risks and benefits of psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

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]

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