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Behavioral Intervention

SMART for Post-Traumatic Stress Disorder (SMART Trial)

N/A

Waitlist Available

Led By Ruth Lanius, MD, PhD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A primary diagnosis of PTSD as determined by our pre-treatment assessment

Adults, aged 18-65

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

SMART Trial Summary

This trial will explore if a movement & body-based treatment (SMART) can help adults with PTSD. Involves 8 SMART sessions, pre-treatment & follow-up assessments.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since SMART involves movement and body-based therapy rather than medication or invasive procedures, side effects may include physical discomfort during activities or emotional distress due to addressing traumatic memories.

SMART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PTSD.

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I am between 18 and 65 years old.

SMART Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.

Change in Clinician Administered PTSD Scale (CAPS) score from pre-treatment to post-treatment assessment.

Secondary outcome measures

Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from post-treatment to 3-month follow-up assessment.

Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-II) score from pre-treatment to post-treatment assessment.

SMART Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active SMARTExperimental Treatment1 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 ListActive Control1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SMART

2015

Completed Phase 2

~470

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

656 Previous Clinical Trials

413,348 Total Patients Enrolled

Ruth Lanius, MD, PhDPrincipal InvestigatorLawson Health Research/Western University/LHSC

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age threshold for this trial accepting participants aged sixty and above?

"The medical trial is looking for patients aged 18 and above, but below 65 years old."

Answered by AI

How can I join this medical experiment?

"To be eligible for this clinical trial, potential participants must suffer from post-traumatic stress disorder and fall in the 18 to 65 age range. This research is hoping to recruit approximately 80 people."

Answered by AI

Is enrollment still ongoing for this research project?

"The clinicaltrials.gov page for this trial reveals that enrollment is no longer available, as it was originally posted on September 30th 2023 and has not been updated since the 18th of September in the same year. Nevertheless, 408 other studies are actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sensory Motor Arousal Regulation Treatment (SMART) Study

Ruth Lanius 2024. "Sensory Motor Arousal Regulation Treatment (SMART) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06035809.