Amygdala for Moral Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lawson Health Research Institute, London, Canada
Moral Injury+2 More
MRI Biofeedback - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Post-traumatic stress disorder (PTSD) is a debilitating and highly prevalent psychiatric disorder that develops in the aftermath of trauma exposure (APA, 2013). PTSD has been strongly associated with altered activation patterns within several large-scale brain networks and, as such, it has been suggested that normalizing pathological brain activation may be an effective treatment approach. The objective of this proposed study is to investigate the ability of PTSD patients to self-regulate aberrant neural circuitry associated with PTSD psychopathology using real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback. Here, the investigators are building upon previous single-session pilot studies examining the regulation of the amygdala and the posterior cingulate cortex (PCC) in PTSD (Nicholson et al., 2021) (Nicholson et al., 2016) by: (1) Examining the effect of multiple sessions of rt-fMRI neurofeedback and, (2) Comparing PCC- and amygdala-targeted rt-fMRI neurofeedback to sham-control groups with regards to changes in PTSD symptoms and neural connectivity.

Eligible Conditions

  • Moral Injury
  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3, and at a 1-week follow-up)

Change in ROI activation between neurofeedback sessions 1, 2, and 3
Region-of-interest (ROI) downregulation analysis over neurofeedback training sessions
Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3, and at a 1-week follow-up)
Change in depressive symptoms (i.e., BDI) over neurofeedback training sessions
Change in dissociation symptoms (i.e., MDI) over neurofeedback training sessions
Change in emotion regulation abilities (i.e., DERS) over neurofeedback training sessions
Change in emotional states of depression, anxiety, and stress (i.e., DASS-21) over neurofeedback training sessions
Change in interoceptive awareness (i.e., MAIA) over neurofeedback training sessions
Change in trauma-related memory recall (i.e., RSDI) over neurofeedback training sessions
Changes in PTSD symptoms over neurofeedback training sessions

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Amygdala
1 of 3
Posterior cingulate cortex (PCC)
1 of 3
Sham-control
1 of 3
Experimental Treatment

60 Total Participants · 3 Treatment Groups

Primary Treatment: Amygdala · No Placebo Group · N/A

Amygdala
Other
Experimental Group · 1 Intervention: MRI Biofeedback · Intervention Types: Other
Posterior cingulate cortex (PCC)
Other
Experimental Group · 1 Intervention: MRI Biofeedback · Intervention Types: Other
Sham-control
Other
Experimental Group · 1 Intervention: Sham-MRI Biofeedback · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3, and at a 1-week follow-up)
Closest Location: Lawson Health Research Institute · London, Canada
2016First Recorded Clinical Trial
0 TrialsResearching Moral Injury
30 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a fluent English speaker.
You are comfortable using electronic devices (i.e., laptop, tablet, smartphone, etc.).
You meet criteria for a primary diagnosis of PTSD via the DSM-5 on the Clinician Administered PTSD Scale (CAPS-5).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References