Condition category
Mental and Behavioural Disorders
Date applied
29/01/2019
Date assigned
06/02/2019
Last edited
05/02/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Military members, veterans, and public safety personnel face numerous physically and mentally stressful events in the line of duty. As a result, they are at greater risk of developing post-traumatic stress disorder (PTSD). A virtual-reality based treatment called Multi-modular Motion-assisted Memory Desensitization and Reconsolidation (3MDR) therapy is a promising intervention for the treatment of combat-related PTSD (cr-PTSD). This study will allow researchers to examine the effect of 3MDR therapy on PTSD symptoms of Canadian Armed Forces (CAF) service members (SMs) with chronic cr-PTSD who do not benefit from other therapies.

Who can participate?
CAF SMs with chronic cr-PTSD who have received previous psychotherapeutic intervention and meet specific inclusion/exclusion criteria may participate in this study.

What does the study involve?
Participants will be randomly assigned to a 3MDR group (treatment group) or control group (treatment as usual (TAU) group). For the treatment group, 2 introductory sessions will be followed by 6 weekly 3MDR sessions and 1 follow up session. The control group will initially receive treatment as usual for 6 weeks, and then 6 sessions of 3MDR.

What are the possible benefits and risks of participating?
The nature of the intervention is such that participants will be exposed to a potentially triggering stimulus indicative of a time in their life that triggered their PTSD symptoms; however, it is likely that this is happening to the participant in their everyday life. Based on the emerging evidence base around utilizing 3MDR and interventions for PTSD utilizing virtual reality, there is a chance that the participants will see improvements in their PTSD symptoms, overall functioning, and quality of life. Since this is an engaging novel technology, it is possible that adherence to this intervention could be better than traditional psychotherapeutic interventions.

Where is the study run from?
Glenrose Rehabilitation Hospital, 10230 111 Avenue Northwest, Edmonton, Alberta, T5G 0B7, Canada

When is the study starting and how long is it expected to run for?
March 2019 for 18 months

Who is funding the study?
Glenrose Rehabilitation Hospital Foundation

Who is the main contact?
Suzette Bremault-Phillips, suzette2@ualberta.ca

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Suzette Bremault-Phillips

ORCID ID

http://orcid.org/0000-0003-4167-1815

Contact details

2-64 Corbett Hall
8205 - 114 Street NW
Edmonton
T6G 2G4
Canada

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Pro00084466/RES0042203

Study information

Scientific title

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

Acronym

3MDRCAREN

Study hypothesis

Participants’ symptoms of PTSD will decrease during the 3DMR therapy utilizing the CAREN system intervention compared with treatment as usual.

Ethics approval

Approved 21/01/2019, Health Research Ethics Board Biomedical Panel, University of Alberta (308 Campus Tower, University of Alberta, Edmonton, AB, T6G 1K8; +1 780 492 9724; reoffice@ualberta.ca), ref: 00084466

Study design

Wait-list-controlled staggered-entry cross-over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Treatment-resistant combat PTSD

Intervention

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 undergo seven main assessments* and 5 smaller in session assessments**:
*baseline assessment to determine if inclusion criteria are met (T0, week 1)
*one assessment at first 3MDR session (T1.1, week 4)
**five in-session assessments (T1.2-1.6, week 5 to 9)
*one post-intervention assessment (T2, week 10)
*one assessment sixteen weeks (T3)
*one assessment at 3 months (T4)
*one assessment at 6 months (T5)
*one assessment at 12 months (T6)

Control Group. The Control Group will receive the same baseline assessment at T0 as the intervention group, followed by 10 weeks of TAU while the intervention group is receiving the 3MDR intervention. Both the control and interventions groups will undergo a post-intervention assessment at week 10 (T2). Following the T2 assessment, participants in the control group will be provided with an opportunity to receive the 3MDR intervention, crossing over into the Intervention Group at that point. Assessments for the control group crossing over into the intervention group will be as follows (Figure 2):
*baseline assessment (T0, week 1)
*one assessment after 10 weeks TAU (T0-1, week 10)
*one assessment at first 3MDR session (T1.1, week 4)
**five in-session assessments (T1.2-1.6, week 5 to 9)
*one post-intervention assessment (T2, week 10)
*one assessment sixteen weeks (T3)
*one assessment at 3 months (T4)
*one assessment at 6 months (T5)
*one assessment at 12 months (T6)

Participants in the Control Group who do not wish to participate in the 3MDR intervention, will undergo the following assessments:
*baseline assessment (T0, week 1)
*one assessment after 10 weeks TAU (T0-1, week 10)
*one assessment sixteen weeks (T3)
*one assessment at 3 months (T4)
*one assessment at 6 months (T5)
*one assessment at 12 months (T6)

Prior to initiating the 3MDR, the participant will have 2 introductory sessions for the purpose of transfer of trust from their attending mental health therapist to the research therapist as well as an introduction to the CAREN. In preparation of 3MDR treatment sessions, participants will come to the Glenrose Hospital to become accustomed to the CAREN system by practising simple standing and walking tasks. Participants will wear a safety harness at all times when in the CAREN system. The harness is secured to the CAREN safety support attachment so that participants do not fall to the ground during a potential stumble. The CAREN system operator will explain all safety procedures during this session. Also, the participant will be asked to bring an array of pictures from their deployment. This can include all material that induced strong memories of the deployment, including letters or decorations. With their therapist, the participant will select the pictures and rank the pictures from lowest to highest affect. The participant will also be asked to bring two digital music tracks: 1 song that reminds the participant of their deployment and 1 song that provides positive feelings.

One week after the initial assessment and introductory sessions, the 3MDR therapy will be initiated.
After arriving for the first of six 3MDR sessions, a physiological monitor will be secured to the participant via a chest strap (Zephyr Bioharness 3). Participants will also be fitted with the CAREN safety harness. At the beginning of each treatment session, the study participant will walk on a level treadmill at a comfortable, fast pace for five minutes while music that reminds the participant of their deployment will be played. Afterwards, a repetitive cycle will start. This cycle has three phases (described below) evolving around one of the deployment-related photographs with high emotionality that are projected on the screen. The emotionality of the stimulus will increase with each cycle. Blood and saliva samples will be procured at the beginning of each 3 MDR sessions.This will be completed by a certified Alberta Health Services Phlebotomist or research nurse. This will take place before and after the 3MDR CAREN intervention. 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. After each session, the therapist and patient will discuss the experience. If the discussion goes beyond the allotted time, the adjacent conference room will be reserved in advance for the participant and therapist to continue the discussion. Also, during subsequent sessions, treatment starts with an evaluation of the previous week, including the thoughts that the patient had between sessions about the events and the intervention. Audio recordings of these semi-structured interviews may happen at this time.
After completing all 3MDR sessions, participants will be asked to complete the same questionnaires from T1 again and answer additional questions about their treatment experience.
Each assessment will take approximately 2.5 hours. This would be repeated 6 times over the course of 1 year. Those in the intervention group will also take part in 6 3MDR sessions (2 hours) and 3 introductory/follow up sessions (1 hour). It is estimated that over a 12 month period, each participant would have donated 30 hours to the study.

Data gathering will involve the following methods:
Interviews and/or Focus Groups
Participant Observation
Surveys and Questionnaires (including internet surveys)
Biobanking (collection of samples to put in a Biobank/Sample Repository)
Collection of Human Biological Materials (ie. blood, tissue etc.)
Chart Review/Review of Health Data

As part of the therapeutic intervention, there will be semi-structured interviewing within the intervention and pre/post assessment with the CAPS assessment by trainer therapists. There will also be semi-structured interviewing around the U-TAUT model. All interviews will be on a one to one basis and will be recorded for later transcription and analysis.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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

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)

Overall trial start date

23/08/2018

Overall trial end date

01/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/03/2019

Recruitment end date

01/10/2020

Locations

Countries of recruitment

Canada

Trial participating centre

Glenrose Rehabilitation Hospital
10230 111 Avenue Northwest
Edmonton
T5G 0B7
Canada

Sponsor information

Organisation

Glenrose Rehabilitation Hospital Foundation

Sponsor details

10230 111 Avenue Northwest
Edmonton
T5G 0B7
Canada

Sponsor type

Charity

Website

https://glenrosefoundation.com/pg1.asp?siteID=1&PIT=home

Funders

Funder type

Hospital/treatment centre

Funder name

Glenrose Rehabilitation Hospital Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

If 3MDR is shown to be efficacious, the proposed research will benefit (1) CAF-SMs with treatment resistant PTSD by providing a new treatment option; (2) clinical services by
providing a means of treating PTSD that has not responded to standard psychological
treatment; and (3) the families and friends of CAF-SMs more generally by minimising the burden of PTSD.

The project will involve a key stakeholder engagement at the launch of the project. We will also publicise the trial through social and local media with the aim of informing the public that the trial is running. Knowledge dissemination will continue thereafter using a variety of tailored methods targeting specific audiences (e.g. infographics, newsletter, website, social media). A summary report of trial results written in lay-language will be sent to study participants and other key stakeholders. The report will also be displayed and available at venues used for recruitment.

Study outcomes will be presented to key stakeholders at an end-of-project KT event and Glenrose Rehabilitation Hospital Foundation’s First Response to Fashion Gala and Spotlight on Innovation. Findings will also be disseminated to the academic community at national and international conferences by means of oral/poster presentations, and interactive workshops. We will target conferences likely to be attended by large numbers such as the Military and Veteran Health Research Forum by the Canadian Institute for Military and Veteran Research (CIMVHR), and the International Trauma and Stress Studies and Treatment (ITSST) Conference. We aim to publish the results in high impact, open-access, peer-reviewed journals.

All the dissemination activities will be supported by web pages such as HiMARC.ca. The web pages will include descriptions of the project, its progress and achievements in plain and scientific language, press releases and announcements of and registration for conferences.
The proposed research will increase our understanding of the potential benefits and
advantages of 3MDR as a potential treatment option for treatment resistant PTSD in CAF-SMs.

Planned publications in multiple high-impact peer-reviewed journals, however the target is the Journal of Military Veterans and Family Health Research.

Intention to publish date

31/12/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes