Virtual Reality–Based Treatment for Military Members and Veterans With Combat-Related Posttraumatic Stress Disorder: Protocol for a Multimodular Motion-Assisted Memory Desensitization and Reconsolidation Randomized Controlled Trial

Abstract

Background Military 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. Objective The 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. Methods This 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. Results This 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. Conclusions The 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 Registration ISRCTN Registry 11264368; http://www.isrctn.com/ISRCTN11264368. International Registered Report Identifier (IRRID) DERR1-10.2196/20620

Technology Acceptance and Usability of the BrainFx SCREEN in Canadian Military Members and Veterans With Posttraumatic Stress Disorder and Mild Traumatic Brain Injury: Mixed Methods UTAUT Study

“…This study of the technology acceptance of the BrainFx SCREEN was a mixed methods embedded study design with a quantitative prequasi-experimental or postquasi-experimental approach as the primary method of data collection and a qualitative thematic analysis secondary to this. This study was embedded in a larger clinical trial, which undertook a mixed methods, staggered entry randomized controlled trial (RCT) [ 32 ].…”

Decreased Emotional Dysregulation Following Multi-modal Motion-assisted Memory Desensitization and Reprocessing Therapy (3MDR): Identifying Driving Factors in Remediation of Treatment-Resistant PTSD

“…Data from recently published RCTs (Bisson et. al, 2020; demonstrate the efficacy of 3MDR therapy among MMs and Veteran populations who experience TR-PTSD (Jones et al, 2020).…”

“…Sessions 8-10 are post-platform sessions focused on reconsolidation and contribute to meaning making of the acquired gains and emotional release. In-depth descriptions of 3MDR have been published elsewhere (van Gelderen et al, 2018;Jones et al, 2020).…”

“…Participants were English-speaking and able to provide informed written consent. A detailed 3MDR protocol has previously been published (Jones et al, 2020).…”

“…Quantitative: Participants were asked to complete a DERS-18 questionnaire prior to starting the 3MDR intervention (T0 baseline) (Jones et al, 2020). Following the intervention, DERS-18 data was collected at four follow-up timepoints: 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) post-intervention.…”