SMART for Post-Traumatic Stress Disorder

(SMART Trial)

Overseen By Suzy - Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Must not be taking: Narcotics

Disqualifiers: Head injury, Neurological disorder, Bipolar, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have extensive narcotic use, you may not be eligible to participate.

What data supports the effectiveness of the treatment SMART for Post-Traumatic Stress Disorder?

Research on similar technology-assisted treatments, like the use of augmented reality and serious gaming for phantom limb pain, shows that these approaches can reduce pain and improve mental health. This suggests that technology-based self-management treatments like SMART could be effective for conditions such as PTSD. ^{1 2 3 4 5}

Is the SMART treatment generally safe for humans?

The available research does not provide specific safety data for the SMART treatment for PTSD, but related studies on technology-assisted treatments for amputees suggest that these interventions are generally well-received and focus on improving mobility and mental health. ^{2 4 6 7 8}

How is the SMART treatment for PTSD different from other treatments?

The SMART treatment for PTSD is unique because it uses technology-assisted self-management, similar to how textile-electrode systems and sensorized shirts are used for home-based rehabilitation in other conditions, allowing patients to manage their treatment at home with remote support. ^{4 5 9 10 11}

What is the purpose of this trial?

This study will investigate whether a movement and body-based treatment can benefit adults with Post-traumatic Stress Disorder (PTSD). The treatment is called Sensory Motor Arousal Regulation Treatment, or "SMART", and study participation involves 8 sessions of SMART, as well as pre-treatment, post-treatment, and 3-month follow-up assessments.

Research Team

Ruth Lanius, MD, PhD

Principal Investigator

Lawson Health Research/Western University/LHSC

Eligibility Criteria

Adults aged 18-65 with PTSD, who can consent and communicate in English, are eligible for the SMART study. Those with implants or conditions unsafe for 7T fMRI, recent suicide attempts, significant head injuries, untreated medical illnesses, neurological disorders, bipolar/psychotic disorders or recent substance abuse cannot participate.

Inclusion Criteria

I have been diagnosed with PTSD.

Ability to provide informed consent

Fluency in written and spoken English (to be able to complete assessments)

Exclusion Criteria

You are using strong pain medications like fentanyl or oxycodone in high amounts.

Any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy)

You have tried to harm yourself in the past 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Assessment

Participants undergo pre-treatment assessments to establish baseline measures

1 week

1 visit (in-person)

Treatment

Participants receive 8 individual, 1-hour, weekly sessions of SMART with a therapist

8 weeks

8 visits (in-person)

Post-treatment Assessment

Participants undergo post-treatment assessments to evaluate changes in PTSD symptoms

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with a 3-month follow-up assessment

12 weeks

1 visit (in-person)

Treatment Details

Interventions

• SMART

Trial Overview The trial is testing Sensory Motor Arousal Regulation Treatment (SMART) to see if it helps adults with PTSD. Participants will undergo eight sessions of SMART therapy and have assessments before treatment starts, after it ends, and three months later.

Participant Groups

Group I: Active SMART Experimental Treatment 1 Intervention

Participants in the active SMART condition will complete 8 individual, 1-hour, weekly sessions of SMART with a therapist, as well as pre-treatment, post-treatment and 3-month follow-up assessments.

Group II: Wait List Active Control 1 Intervention

Participants in the Wait List condition will receive no treatment for approximately 8 weeks, and they will be asked to complete pre-wait list, post-wait list and 3-month follow-up assessments. After all assessments have been completed, this group will be offered the same 8 individual, 1-hour, weekly sessions of SMART (no further assessments needed).

SMART is already approved in Canada for the following indications:

Approved in Canada as SMART for:

• Lower Limb Amputation Rehabilitation

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Findings from Research

A new textile-electrode system for self-administered Phantom Motor Execution (PME) treatment showed promising results in reducing Phantom Limb Pain (PLP) for one patient, highlighting its potential efficacy for home use.

The patient reported not only reduced pain but also increased mobility and improved mental health, suggesting that factors like motivation and usability are important for the success of home-based treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards Implementation of a Home-Based Phantom Limb Pain Treatment Facilitated by Textile-Electrode System - A Case Study. Björkquist, A., Guo, L., Kristoffersen, MB., et al.[2023]

The SQUID smart shirt, which uses electromyography (EMG) and heart rate monitoring, offers a promising low-cost solution for remote rehabilitation of stroke patients, allowing for home-based therapy with real-time feedback.

Initial testing with a healthy subject demonstrated the system's ability to provide audiovisual and haptic feedback during exercises, indicating its potential for automated monitoring and support in physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SQUID: sensorized shirt with smartphone interface for exercise monitoring and home rehabilitation. Farjadian, AB., Sivak, ML., Mavroidis, C.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial to evaluate the feasibility of the Wii Fit for improving walking in older adults with lower limb amputation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Wearable Vibrotactile Biofeedback Device Allowing Identification of Different Floor Conditions for Lower-Limb Amputees. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Gait pattern alteration by functional sensory substitution in healthy subjects and in diabetic subjects with peripheral neuropathy. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Towards Implementation of a Home-Based Phantom Limb Pain Treatment Facilitated by Textile-Electrode System - A Case Study. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Out of the Clinic, into the Home: The in-Home Use of Phantom Motor Execution Aided by Machine Learning and Augmented Reality for the Treatment of Phantom Limb Pain. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Servicemembers and veterans with major traumatic limb loss from Vietnam war and OIF/OEF conflicts: survey methods, participants, and summary findings. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Unilateral lower-limb loss: prosthetic device use and functional outcomes in servicemembers from Vietnam war and OIF/OEF conflicts. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Use and satisfaction with prosthetic devices among persons with trauma-related amputations: a long-term outcome study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

SQUID: sensorized shirt with smartphone interface for exercise monitoring and home rehabilitation. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Psychological state estimation from physiological recordings during robot-assisted gait rehabilitation. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Virtual proprioception with real-time step detection and processing. [2020]