Brief Exposure Therapy for PTSD
(PTSD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's Hospital Los Angeles
Disqualifiers: Substance dependence, Psychotic disorders, Bipolar, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
678910How 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.
245711Eligibility 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
+4 more
Exclusion Criteria
Patient Population: Acute intoxication
Patient Population: Severe level of Substance Dependence (6 or more DSM-V symptoms)
Patient Population: Dementia
+17 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Image Exposure ArmExperimental Treatment1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brain Imaging LabLos Angeles, CA
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Who Is Running the Clinical Trial?
Children's Hospital Los AngelesLead Sponsor
References
A preliminary investigation of sudden gains in exposure therapy for PTSD. [2021]The purpose of the current study was to examine sudden gains in those receiving treatment for PTSD and whether these rapid changes were related to overall symptom reduction in a small sample of female assault survivors with PTSD undergoing prolonged exposure (PE) therapy. Sudden gains were found to occur in 52% of the sample. Among those who experienced a sudden gain, the average magnitude (12.4 points) accounted for 61% of overall symptom reduction. Importantly, treatment outcome was better for those who experienced sudden gains than those who did not. The experience of a sudden gain may result in patients becoming more fully engaged with treatment, and recognition of them may result in identifying potential process-related predictors of treatment response.
Augmenting trauma-focused psychotherapy for post-traumatic stress disorder with brief aerobic exercise in Australia: a randomised clinical trial. [2022]Although exposure therapy is central in most front-line psychotherapies of post-traumatic stress disorder (PTSD), many patients do not respond to this treatment. We aimed to investigate the effects of brief aerobic exercise on the efficacy of exposure therapy in reducing the severity of PTSD.
Effectiveness of written exposure therapy for posttraumatic stress disorder in the Department of Veterans Affairs Healthcare System. [2023]Written Exposure Therapy (WET) for posttraumatic stress disorder (PTSD) has been shown to be efficacious in clinical trials; however, research is needed to determine WET's effectiveness in clinical practice settings. Additionally, research is needed to understand whether patient characteristics or treatment delivery format moderate outcomes.
Predictors and Outcomes of Growth Mixture Modeled Trajectories Across an Exposure-Based PTSD Intervention With Veterans. [2019]Exposure-based psychotherapies for posttraumatic stress disorder (PTSD) are effective for many, but not all patients. It is important to determine for whom these treatments work and to examine predictors of success.
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]Posttraumatic stress disorder (PTSD) occurs more commonly among military service members than among civilians; however, despite the availability of several evidence-based treatments, there is a need for more efficient evidence-based PTSD treatments to better address the needs of service members. Written exposure therapy is a brief PTSD intervention that consists of 5 sessions with no between-session assignments, has demonstrated efficacy, and is associated with low treatment dropout rates, but prior randomized clinical trials of this intervention have focused on civilian populations.
Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]The assessment of safety data has become a standard across many clinical interventions. The aim of this systematic review is to investigate the extent to which harm is addressed within psychotherapy study protocols. The review includes study protocols of randomized controlled trials published between 2004 and 2017 investigating the effects of psychotherapy in adult patients with affective disorders, phobia, anxiety, obsessive-compulsive disorder, posttraumatic stress disorder, and/or personality disorders. We conducted a systematic search in the CENTRAL, Medline, PsycINFO, and Web of Science databases as well as in relevant journals. In total, 115 study protocols were included, examining 168 psychotherapy and 85 control conditions. These protocols differed considerably in the way they conceptualized harm: 77 explicitly addressed harm, 62 considered serious adverse events, and 39 considered adverse events. Although serious adverse events were defined somewhat consistently, adverse events were not. Our results imply that clinical researchers do not apply standardized approaches with regard to harm concepts, assessment, and management. To gather data on frequencies of harmful effects, we argue a higher degree of standardization would be useful. Feasible recommendations are provided based on examples of good practice from the reviewed study protocols. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Exposure therapy for posttraumatic stress disorder. [2018]Exposure therapy is a well-established treatment for Posttraumatic Stress Disorder (PTSD) that requires the patient to focus on and describe the details of a traumatic experience. Exposure methods include confrontation with frightening, yet realistically safe, stimuli that continues until anxiety is reduced. A review of the literature on exposure therapy indicates strong support from well-controlled studies applied across trauma populations. However, there are many misconceptions about exposure therapy that may interfere with its widespread use. These myths and clinical guidelines are addressed. It is concluded that exposure therapy is a safe and effective treatment for PTSD when applied as directed by experienced therapists.
Trauma-focused cognitive-behavioral therapies for posttraumatic stress disorder under ongoing threat: A systematic review. [2021]Some individuals with posttraumatic stress disorder (PTSD) are at elevated risk of reexposure to trauma during treatment. Trauma-focused cognitive-behavioral therapies (CBT) are recommended as first-line PTSD treatments but have generally been tested with exclusion criteria related to risk for trauma exposure. Therefore, there is limited knowledge on how to best treat individuals with PTSD under ongoing threat of reexposure. This paper systematically reviewed the effectiveness of CBTs for PTSD in individuals with ongoing threat of reexposure. Literature searches yielded 21 studies across samples at ongoing risk of war-related or community violence (n = 14), domestic violence (n = 5), and work-related traumatic events (n = 2). Medium to large effects were found from pre to posttreatment and compared with waitlist controls. There were mixed findings for domestic violence samples on long-term outcomes. Treatment adaptations focused on establishing relative safety and differentiating between realistic threat and generalized fear responses. Few studies examined whether ongoing threat influenced treatment outcomes or whether treatments were associated with adverse events. Thus, although the evidence is promising, conclusions cannot be firmly drawn about whether trauma-focused CBTs for PTSD are safe and effective for individuals under ongoing threat. Areas for further inquiry are outlined.
Adverse events in psychotherapy randomized controlled trials: A systematic review. [2023]Objective: Although evidence for benefits of psychotherapy is substantial, less is known about potential harm. Therefore, we systematically summarized randomized controlled trials (RCTs) to compile evidence-based data on the frequency and characteristics of adverse events (AEs) of psychotherapy. Method: This systematic review of result publications is based on a review of harm consideration in psychotherapy study protocols. Results: On the basis of 115 study protocols, 85 RCTs with 126 psychotherapy and 61 control conditions were eligible for inclusion. The sample consisted of 14,420 participants with the most common mental disorders. Harmful events, e.g., AEs, number of individuals with symptom deterioration, were explicitly reported in 60% of the studies. Conceptualization, recording, and reporting of AEs were heterogeneous. For most reported AEs, the association to study treatment remained unclear. Conclusions: Because the AE recording approaches of the individual studies differed substantially, results could only be compared to a limited extent. Consistent with other findings, this review demonstrates that AEs can be expected to affect more than one in ten participants. Serious AEs occurred more than in one in 21 participants in psychotherapy RCTs. To allow a balanced risk/benefit evaluation of psychotherapy, systematic harm monitoring and reporting should become standard in psychotherapy RCTs.
The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]Monitoring for possible adverse events is ethically required by Institutional Review Boards and Good Clinical Practice guidelines for all human research involving the delivery of treatment interventions in a clinical trial. The monitoring of adverse events is a well-established and routine practice for contemporary clinical trials involving medications and medical devices. However, these same guidelines have not been fully integrated into clinical trials involving the use of behavioral health interventions and psychotherapy. Most behavioral health clinical trials limit adverse event monitoring to serious adverse events such as suicide attempts, completed suicides, and psychiatric hospitalizations. Other possible "side effects" of psychotherapy, such as temporary increases in anxiety, are often considered a normal part of therapy and are therefore not documented as possible adverse events. This manuscript reviews a variety of reasons for the limited adverse event monitoring in behavioral health clinical trials and highlights the importance of incorporating expanded adverse event monitoring into future behavioral health clinical trials. Without understanding the nature and prevalence of adverse events, patients cannot be informed adequately of the possible risks and benefits of behavioral interventions prior to engaging in treatment.
Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. [2023]Evidence-based treatments for posttraumatic stress disorder (PTSD) exist, but all require 8 to 15 sessions and thus are less likely to be completed than brief treatments. Written exposure therapy (WET) is a brief and efficacious treatment that has not been directly compared with prolonged exposure therapy (PE), a more time-intensive, exposure-based treatment.