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

Trial Summary

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 data supports the effectiveness of the treatment Very Brief Exposure Therapy for PTSD?

Research shows that exposure-based therapies, like Very Brief Exposure Therapy, can lead to significant symptom reduction in PTSD patients. For example, sudden gains in symptom reduction were observed in 52% of patients undergoing prolonged exposure therapy, suggesting that similar brief therapies may also be effective. ^{1 2 3 4 5}

Is Brief Exposure Therapy for PTSD safe for humans?

Exposure therapy, including Brief Exposure Therapy, is generally considered safe for treating PTSD when conducted by experienced therapists. However, adverse events (unwanted effects) can occur in psychotherapy, affecting more than one in ten participants, and serious adverse events are less common. Monitoring for these events is important to ensure patient safety. ^{6 7 8 9 10}

How is Very Brief Exposure Therapy different from other PTSD treatments?

Very Brief Exposure Therapy is unique because it is a shorter, more efficient form of exposure therapy that requires fewer sessions, making it easier for patients to complete compared to traditional treatments that often require 8 to 15 sessions. ^{2 4 5 7 11}

What is the purpose of this trial?

The goal of this clinical trial is to develop a new behavioral treatment for U.S. combat veterans with post-traumatic stress disorder (PTSD), very brief exposure to combat-related stimuli. The main questions it aims to answer are: 1. How does Very Brief Exposure (combat images and control everyday images) and Visible Exposure to combat stimuli affect brain activity and subjective fear ratings? 2. To what extent are participants aware of the stimuli presented and tolerating the exposures? All participants will view both very brief exposure and visible exposure to combat stimuli in the functional magnetic brain imaging (fMRI) scan. They will provide ratings of fear, awareness, and tolerability. Researchers will compare U.S. combat veterans with PTSD and healthy controls to confirm differences in brain region activation and ratings.

Research Team

Bradley S. Peterson, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A preliminary investigation of sudden gains in exposure therapy for PTSD. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Augmenting trauma-focused psychotherapy for post-traumatic stress disorder with brief aerobic exercise in Australia: a randomised clinical trial. [2022]

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

Effectiveness of written exposure therapy for posttraumatic stress disorder in the Department of Veterans Affairs Healthcare System. [2023]

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

Predictors and Outcomes of Growth Mixture Modeled Trajectories Across an Exposure-Based PTSD Intervention With Veterans. [2019]

5. United States 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. [2022]

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

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

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

Exposure therapy for posttraumatic stress disorder. [2018]

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

Trauma-focused cognitive-behavioral therapies for posttraumatic stress disorder under ongoing threat: A systematic review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. [2023]

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

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

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

Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. [2023]