Virtual-reality based treatment for Canadian armed forces members with combat-related post-traumatic stress disorder (PTSD)

Not Applicable

• Conditions: Treatment-resistant combat PTSD; Mental and Behavioural Disorders

• Registration Number: ISRCTN11264368
• Lead Sponsor: Glenrose Rehabilitation Hospital Foundation

Brief Summary

2020 protocol in https://pubmed.ncbi.nlm.nih.gov/33118957/ (added 30/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-06
• Last Update Posted: 9 November 2020
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

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 satisfy the other inclusion/exclusion criteria and PTSD is considered the primary diagnosis
7. Must provide informed consent

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Measured at baseline, week 11, 3 months, 6 months, and 12 months:<br> 1.1 Moral Injury (Moral Injury Symptom Scale)<br> 1.2 Alcohol Consumption (AUDIT)<br> 1.3 Depression (PHQ-9)<br> 1.4 Anxiety (GAD-7)<br> 1.5 Social Function (OQ-45)<br> 1.6 Quality of Life (EQ5D-5L)<br> 2. Sessions 3 to 8 on the CAREN System (weeks 5 to 11):<br> 2.1 Gait Analysis (CAREN)<br> 2.2 Heart Rate (Zepher Bio Harness 3)<br> 2.3 Breathing Rate (Zepher Bio Harness 3)<br> 2.4 Force Plate Analysis (CAREN)<br> 2.5 Eye tracking (Tobii Pro)<br> 2.6 EEG (Tobii Pro 2)<br> 2.7 Client Satisfaction (CSQ-8)<br> 3. Final CAREN Session Only (week 11)<br> 3.1 Usability of CAREN (UTAUT)<br> 3.2 3MDR Satisfaction (3MDR-Q)<br>