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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help adults with Post-traumatic Stress Disorder (PTSD) using Sensory Motor Arousal Regulation Treatment (SMART). Participants will attend eight one-hour sessions focused on movement and body-based techniques. The trial includes assessments before and after the treatment, with a follow-up three months later. Suitable candidates for this trial are adults diagnosed with PTSD who can attend sessions in English. As an unphased trial, this study provides a unique opportunity to explore innovative treatment methods for PTSD.

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 prior data suggests that this treatment is safe for adults with PTSD?

Research shows that Sensory Motor Arousal Regulation Treatment (SMART) is still under study, and clear information on its safety for people with PTSD is not yet available. The current clinical trial is in the "Not Applicable" phase, indicating limited safety data specifically on SMART. This phase focuses on evaluating the treatment's effectiveness and safety, so researchers are closely monitoring SMART for any potential risks or side effects.

SMART aims to help control body movements and reactions. However, without specific safety data from past studies, participants should be aware that the treatment is still in testing. Participants are encouraged to discuss any concerns with the trial staff or their healthcare providers, especially if they feel uncomfortable during sessions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SMART protocol for treating Post-Traumatic Stress Disorder (PTSD) because it focuses on structured, short-term therapy sessions that can be more accessible and less time-consuming than traditional methods like prolonged exposure therapy or cognitive processing therapy. SMART involves just eight weekly, one-hour sessions, which could lead to quicker relief for patients compared to other therapies that often require more extended engagement. Additionally, SMART is designed to empower patients by actively involving them in their treatment process, potentially leading to more sustainable outcomes and greater personal agency in managing PTSD symptoms.

What evidence suggests that SMART could be an effective treatment for PTSD?

Research shows that Sensory Motor Arousal Regulation Treatment (SMART) might help people with Post-Traumatic Stress Disorder (PTSD). Although few studies focus specifically on SMART for PTSD, this therapy uses movement and body-based techniques to manage stress and emotions. Participants in this trial will join either the Active SMART arm, completing 8 individual, 1-hour weekly sessions with a therapist, or the Wait List arm, receiving no treatment for approximately 8 weeks before being offered the same SMART sessions. This therapy aims to help individuals feel more in control and grounded by involving their body in therapeutic exercises. It often increases awareness of physical and emotional feelings, which can be especially useful for managing PTSD symptoms. While research is ongoing, the basic principles of SMART suggest it could offer support and relief for PTSD symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Ruth Lanius, MD, PhD

Principal Investigator

Lawson Health Research/Western University/LHSC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36803503/

self-management for amputee rehabilitation using ... Purpose: To develop an online self-management program for individuals with recent lower limb loss, called Self-Management for Amputee ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04953364

Self-Management for Amputee Rehabilitation Using ... The purpose of this randomized controlled trial is to evaluate the effect of SMART in community dwelling older adults with unilateral, above or below, knee ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0278418

Protocol for a randomized controlled trial to assess the effect ... SMART has the potential to provide knowledge and skill development to augment rehabilitation outcomes for adults with LLL.

4. trialx.com trialx.com/clinical-trials/listings/317595/self-management-for-amputee-rehabilitation-using-technology/

Self-Management for Amputee Rehabilitation Using ... The purpose of this randomized controlled trial is to evaluate the effect of SMART in community dwelling older adults with unilateral, above or below, knee ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04120038

Self-Management for Amputee Rehabilitation Using ... The purpose of this study is to determine the effect of 6 weeks of the SMART Program on the walking capacity and confidence of individuals with ...

6. clinicaltrials.gov clinicaltrials.gov/show/NCT04120038

Self-Management for Amputee Rehabilitation Using ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36952517/

Protocol for a randomized controlled trial to assess the ... SMART has the potential to provide knowledge and skill development to augment rehabilitation outcomes for adults with LLL.