Multi-modal virtual-reality based (3MDR) treatment for Canadian armed forces members with combat-related post-traumatic stress disorder: a computer-assisted rehabilitation environment (CAREN) waitlist controlled staggered entry study
Treatment-resistant combat PTSD
Participants will be randomized to the 3MDR or Treatment as Usual (TAU) groups in a parallel design. Random assignment will be done on a 1:1 basis by a computer program, with a weighted maximum of subscribing three times the same condition in a row. An arms-length research assistant will randomly assign and keep a confidential log of all participants assigned to either 3MDR or TAU treatment. Prior to beginning 3MDR treatment sessions, participants will undergo a baseline assessment. The baseline assessment will include a series of outcome measures collected online using REDCap, baseline blood and saliva samples, and a semi-structured interview, all of which aim to gather information about the severity of PTSD symptoms, anxiety and depression symptoms, alcohol use, quality of life, social functioning, avoidance behavior, expectations of the intervention and level of neurofunctioning. Responses to questionnaires will be securely captured and stored online using RedCap, a secure, web-based application for building and managing online research projects. (REDCap is built and supported by a team at Vanderbilt University and is licensed by the Women and Children’s Health Research Institute on behalf of the University of Alberta). In addition to baseline and follow up data collection using the aforementioned outcome measures, measures will be routinely administered in the course of the intervention (e.g., the SUD and PDEQ) or as needed for monitoring purposes. Participant responses will be securely collected and stored on REDCap's secure server. Walking and eye scanning patterns, as well as physiological data, will be collected during the training session through the CAREN system, Tobii Mobile Eye -tracking glasses, and Zephyr BioHarness 3. Video-recording of the session will capture qualitative data associated with the exchange between the therapist and participant in the course of the 3MDR session. Intervention Group. All participants in the Intervention Group will und
Current inclusion criteria as of 13/03/2025: Individuals being considered for participation in the 3MDR study must: 1. Be aged 18 or more years 2. Be English speaking 3. Be from one or more of the following groups: 3.1. Regular and reserve Canadian Armed Forces service members, and Veterans 3.2. Public safety personnel (PSP - e.g., paramedics, police, firefighters, and correction officers) 3.3. Healthcare professionals (HCP) and Essential service providers (ESP) 3.4. Adult family members of the aforementioned groups 3.5. General public 4. Have one or more of the following concerns present for at least 3 months: 4.1. Official diagnosis of PTSD from a mental health professional 4.2. A post-traumatic or operational stress injury or other related mental health condition 4.3. Score below 30 on the Clinician-Administered PTSD Scale (CAPS-5) 4.4. Trauma associated with service provision during the COVID-19 pandemic 4.5. Military sexual trauma 4.6. Moral injury; and/or 4.7. Stress-related condition 5. Agree to be screened by a research team member for study eligibility 6. Be able to participate in 3MDR at one of the study sites for 2 hours, once a week for 10 to 14 consecutive weeks and engage in follow-up sessions 7. Be under the care of a healthcare provider or team (primary service provider) for mental health needs during the course of 3MDR and following receipt of the intervention. If the individual's 3MDR therapist is not their regular mental healthcare provider, the primary service provider would need to provide authorization for the individual's potential participation in the 3MDR study, as well as consent for the release of information to the research team. Note that the research team will not provide ongoing physical or mental health support 8. Be able to walk on a treadmill for 1 hour (or, if the individual uses a wheelchair, be able to maintain a regular wheelchair pace for 60 minutes on a wheelchair trainer unit, which is equivalent to a treadmill for a wheelcha
Current exclusion criteria as of 13/03/2025: 1. Acute suicidality 2. Inability to walk at a normal pace for 30-45 minutes on a treadmill 3. Acute psychosis 4. Participant is not socially appropriate 5. Reduced cognitive processing that would exclude the participant from following directions 6. Significant history of non-attendance in previous therapies 7. The physical size or abilities of the participant are not compatible with the CAREN system 8. Significant history of non-attendance in previous therapies Previous exclusion criteria: 1. Acute suicidality 2. Inability to walk at a normal pace for 30-45 minutes on a treadmill 3. Acute psychosis 4. Participant is not socially appropriate 5. Reduced cognitive processing that would exclude the participant from following directions 6. Significant history of non-attendance in previous therapies 7. The physical size or abilities of the participant are not compatible with the CAREN system