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Early intervention for preventing posttraumatic stress disorder: an Internet-based virtual reality treatment.

ABSTRACT: BACKGROUND:Posttraumatic stress disorder (PTSD) develops in approximately 20% of people exposed to a traumatic event, and studies have shown that cognitive-behavioral therapy (CBT) is effective as a treatment for chronic PTSD. It has also been shown to prevent PTSD when delivered early after a traumatic event. However, studies have shown that uptake of early treatment is generally low, and therefore, the need to provide interventions through other mediums has been identified. The use of technology may overcome barriers to treatment. OBJECTIVE:This paper describes a randomized controlled trial that will examine an early CBT intervention for PTSD. The treatment incorporates virtual reality (VR) as a method for delivering exposure-based elements of the treatment. The intervention is Internet based, such that the therapist and patient will "meet" in a secure online site. This site will also include multi-media components of the treatment (such as videos, audios, VR) that can be accessed by the patient between sessions. METHOD:Two hundred patients arriving to a Level 1 emergency department following a motor vehicle accident will be randomly assigned to either treatment or control groups. Inclusion criteria are age 18-65, PTSD symptoms 2 weeks posttrauma related to current trauma, no suicidality, no psychosis. Patients will be assessed by telephone by a team blind to the study group, on four occasions: before and after treatment, and 6 and 12 months posttreatment. The primary outcome is PTSD symptoms at follow up. Secondary outcomes include depression and cost effectiveness. Analyses will be on an intention-to-treat basis. DISCUSSION:The results will provide more insight into the effects of preventive interventions, in general, and Internet-based early interventions, in particular, on PTSD, in an injured population, during the acute phase after trauma. We will discuss possible strengths and limitations.

SUBMITTER: Freedman SA

PROVIDER: S-EPMC4385907 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Project description:ImportancePosttraumatic stress disorder (PTSD) is a common psychiatric disorder that is particularly difficult to treat in military veterans. Noninvasive brain stimulation has significant potential as a novel treatment to reduce PTSD symptoms.ObjectiveTo test whether active transcranial direct current stimulation (tDCS) plus virtual reality (VR) is superior to sham tDCS plus VR for warzone-related PTSD.Design, setting, and participantsThis double-blind randomized clinical trial was conducted among US military veterans enrolled from April 2018 to May 2023 at a secondary care Department of Veterans Affairs hospital and included 1- and 3-month follow-up visits. Participants included US military veterans with chronic PTSD and warzone-related exposure, recruited via referral and advertisement. Patients in psychiatric treatment had to be on a stable regimen for at least 6 weeks to be eligible for enrollment. Data were analyzed from May to September 2023.InterventionParticipants were randomly assigned to receive 2-mA anodal tDCS or sham tDCS targeted to the ventromedial prefrontal cortex, during six 25-minute sessions of standardized warzone VR exposure, delivered over 2 to 3 weeks.Main outcomes and measuresThe co-primary outcomes were self-reported PTSD symptoms, measured via the PTSD checklist for DSM-5 (PCL-5), alongside quality of life. Other outcomes included psychophysiological arousal, clinician-assessed PTSD, depression, and social/occupational function.ResultsA total of 54 participants (mean [SD] age, 45.7 [10.5] years; 51 [94%] males) were assessed, including 26 in the active tDCS group and 28 in the sham tDCS group. Participants in the active tDCS group reported a superior reduction in self-reported PTSD symptom severity at 1 month (t = -2.27, P = .02; Cohen d = -0.82). There were no significant differences in quality of life between active and sham tDCS groups. Active tDCS significantly accelerated psychophysiological habituation to VR events between sessions compared with sham tDCS (F5,7689.8 = 4.65; P < .001). Adverse effects were consistent with the known safety profile of the corresponding interventions.Conclusions and relevanceThese findings suggest that combined tDCS plus VR may be a promising strategy for PTSD reduction and underscore the innovative potential of these combined technologies.Trial registrationClinicalTrials.gov Identifier: NCT03372460.

Project description:Posttraumatic stress disorder (PTSD) is a significant public health issue. Yet, there are limited treatment options and no data to suggest which treatment will work for whom. We tested the efficacy of virtual reality exposure (VRE) or prolonged imaginal exposure (PE), augmented with D-cycloserine (DCS) for combat-related PTSD. As an exploratory aim, we examined whether brain-derived neurotrophic factor (BDNF) and fatty acid amide hydrolase (FAAH) moderated treatment response. Military personnel with PTSD (n = 192) were recruited into a multisite double-blind randomized controlled trial to receive nine weeks of VRE or PE, with DCS or placebo. Primary outcome was the improvement in symptom severity. Randomization was stratified by comorbid depression (MDD) and site. Participants in both VRE and PE showed similar meaningful clinical improvement with no difference between the treatment groups. A significant interaction (p = 0.45) suggested VRE was more effective for depressed participants (CAPS difference M = 3.51 [95% CI 1.17-5.86], p = 0.004, ES = 0.14) while PE was more effective for nondepressed participants (M = -8.87 [95% CI -11.33 to -6.40], p < 0.001, ES = -0.44). The main effect of DCS vs. placebo was not significant. Augmentation by MDD interaction (p = 0.073) suggested that depressed participants improved more on placebo (M = -8.43 [95% CI -10.98 to -5.88], p < 0.001, ES = -0.42); DCS and placebo were equally effective for nondepressed participants. There was an apparent moderating effect of BDNF Val66Met polymorphism on DCS augmentation (ES = 0.67). Met66 allele carriers improved more on DCS (ES = -0.25). FAAH 385 A carriers improved more than non-carriers (ES = 0.33), particularly those with MDD (ES = 0.62). This study provides a step toward precision therapeutics for PTSD by demonstrating that comorbid MDD and genetic markers may help guide treatment selection.ClinicalTrials.gov Identifier: NCT01352637.

Project description:BackgroundMilitary members are at elevated risk of operational stress injuries, including posttraumatic stress disorder (PTSD) and moral injury. Although psychotherapy can reduce symptoms, some military members may experience treatment-resistant PTSD. Multimodular motion-assisted memory desensitization and reconsolidation (3MDR) has been introduced as a virtual reality (VR) intervention for military members with PTSD related to military service. The 3MDR intervention incorporates exposure therapy, psychotherapy, eye movement desensitization and reconsolidation, VR, supportive counselling, and treadmill walking.ObjectiveThe objective of this study is to investigate whether 3MDR reduces PTSD symptoms among military members with combat-related treatment-resistant PTSD (TR-PTSD); examine the technology acceptance and usability of the Computer Assisted Rehabilitation ENvironment (CAREN) and 3MDR interventions by Canadian Armed Forces service members (CAF-SMs), veterans, 3MDR clinicians, and operators; and evaluate the impact on clinicians and operators of delivering 3MDR.MethodsThis is a mixed-methods waitlist controlled crossover design randomized controlled trial. Participants include both CAF-SMs and veterans (N=40) aged 18-60 years with combat-related TR-PTSD (unsuccessful experience of at least 2 evidence-based trauma treatments). Participants will also include clinicians and operators (N=12) who have been trained in 3MDR and subsequently utilized this intervention with patients. CAF-SMs and veterans will receive 6 weekly 90-minute 3MDR sessions. Quantitative and qualitative data will be collected at baseline and at 1, 3, and 6 months postintervention. Quantitative data collection will include multiomic biomarkers (ie, blood and salivary proteomic and genomic profiles of neuroendocrine, immune-inflammatory mediators, and microRNA), eye tracking, electroencephalography, and physiological data. Data from outcome measures will capture self-reported symptoms of PTSD, moral injury, resilience, and technology acceptance and usability. Qualitative data will be collected from audiovisual recordings of 3MDR sessions and semistructured interviews. Data analysis will include univariate and multivariate approaches, and thematic analysis of treatment sessions and interviews. Machine learning analysis will be included to develop models for the prediction of diagnosis, symptom severity, and treatment outcomes.ResultsThis study commenced in April 2019 and is planned to conclude in April 2021. Study results will guide the further evolution and utilization of 3MDR for military members with TR-PTSD and will have utility in treating other trauma-affected populations.ConclusionsThe goal of this study is to utilize qualitative and quantitative primary and secondary outcomes to provide evidence for the effectiveness and feasibility of 3MDR for treating CAF-SMs and veterans with combat-related TR-PTSD. The results will inform a full-scale clinical trial and stimulate development and adaptation of the protocol to mobile VR apps in supervised clinical settings. This study will add to knowledge of the clinical effectiveness of 3MDR, and provide the first comprehensive analysis of biomarkers, technology acceptance and usability, moral injury, resilience, and the experience of clinicians and operators delivering 3MDR.Trial registrationISRCTN Registry 11264368; http://www.isrctn.com/ISRCTN11264368.International registered report identifier (irrid)DERR1-10.2196/20620.

Project description:BackgroundMajor depressive disorder (MDD) is a global problem with an increasing incidence and prevalence. There has additionally been an increase in depression due to the COVID-19 pandemic. Behavioral activation is considered an evidence-based treatment for MDD. However, there are many barriers that could hinder one's ability to engage in behavioral activation, with COVID-19 "shelter-in-place" and social distancing orders being current and large impediments. Virtual reality (VR) has been successfully used to help treat a variety of mental health conditions, but it has not yet been used as a method of administering behavioral activation to a clinical population. Using VR to engage in behavioral activation could eliminate barriers that pandemic precautions place and help decrease symptoms of depression that are especially exacerbated in these times.ObjectiveThe following case report examines the feasibility, acceptability, and tolerability of VR behavioral activation for an adult with MDD during a global pandemic. This participant was part of a larger pilot study, and the case serves as a description of the VR intervention.MethodsThe participant engaged in a weekly 50-minute psychotherapy Zoom session for 4 weeks, in which a modified behavioral activation protocol was administered using a VR headset to simulate activities. Data on mood ratings, homework compliance, and headset use were obtained from the headset. Acceptability, tolerability, and depression symptoms were obtained using self-report rating scales.ResultsThe intervention was feasible, acceptable, and tolerable, as reported by this participant. The participant's depressive symptoms decreased by five-points on the Patient Health Questionnaire-9 over a month, with a beginning score of 10 (moderate depression) and a final score of 5 (mild depression).ConclusionsThe implications of these findings for future research are discussed.Trial registrationClinicalTrials.gov NCT04268316; http://clinicaltrials.gov/ct2/show/NCT04268316.

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Early intervention for preventing posttraumatic stress disorder: an Internet-based virtual reality treatment.

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