Treatment-resistant combat PTSD Mental and Behavioural Disorders
Conditions
Interventions
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 sub
Sponsors
Glenrose Rehabilitation Hospital Foundation
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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 wheelchair user) 9. Would benefit from psychotherapy and be able to process trauma, learn new things, and reconsolidate memories 10. If engaging in psychotherapeutic intervention, be stable on a consistent treatment regime and agree not to enter into new interventions during receipt of the 3MDR intervention 11. If undergoing pharmacotherapy, be stable on their current psychotropic medication for a period of 4 weeks before entering the trial and agree to not increase dosages or add any new medications during the course of the trial 12. If using substances (e.g., alcohol or cannabis), its use must be stable and not interfere with effectively engaging in trauma therapy 13. If individuals have co-morbid conditions, other inclusion/exclusion criteria must be satisfied Previous inclusion criteria: 1. CAF service members (CAF-SMs) aged 18-60 years 2. Meet DSM-5 Criteria for PTSD diagnosis (with chronic cr-PTSD (symptoms >3 months) 3. Treatment-resistant to treatment as usual (TAU) psychotherapeutic PTSD treatment, i.e. have not responded to at least two types of evidence-based treatments, at least one of which must be a psychotherapeutic intervention 4. Have a score of 50 or higher on the Clinician-Administered PTSD Scale for DSM-5 (CAPS). 5. Stable on their current psychotropic medication for a period of 4 weeks before entering the trial and agree to not increase dosages or add any new medications during the course of the trial 6. Individuals with co-morbidity will be included if they sat
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PTSD symptomology measured using the clinically administered PTSD Scale (CAPS), PTSD symptoms (PCL-5), posttraumatic avoidance behaviour questionnaire (PABQ), neurofunctioning (Brain FX), and dissociative experiences (PDEQ) measured pre/post-intervention, as well as follow up at 3 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measured at baseline, week 11, 3 months, 6 months, and 12 months: 1.1. Moral Injury (Moral Injury Symptom Scale) 1.2. Alcohol Consumption (AUDIT) 1.3. Depression (PHQ-9) 1.4. Anxiety (GAD-7) 1.5. Social Function (OQ-45) 1.6. Quality of Life (EQ5D-5L) 2. Sessions 3 to 8 on the CAREN System (weeks 5 to 11): 2.1. Gait Analysis (CAREN) 2.2. Heart Rate (Zepher Bio Harness 3) 2.3. Breathing Rate (Zepher Bio Harness 3) 2.4. Force Plate Analysis (CAREN) 2.5. Eye tracking (Tobii Pro) 2.6. EEG (Tobii Pro 2) 2.7. Client Satisfaction (CSQ-8) 3. Final CAREN Session Only (week 11) 3.1. Usability of CAREN (UTAUT) 3.2. 3MDR Satisfaction (3MDR-Q) | — |
Countries
Canada
Outcome results
None listed