Amygdala for Moral Injury
Phase-Based Progress Estimates
Effectiveness
Safety
Lawson Health Research Institute, London, Canada
Moral Injury+2 More
MRI Biofeedback - OtherEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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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
Other trials for Moral Injury
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
Other trials for Moral Injury
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: OtherPosterior cingulate cortex (PCC)
Other
Experimental Group · 1 Intervention: MRI Biofeedback · Intervention Types: OtherSham-control
Other
Experimental Group · 1 Intervention: Sham-MRI Biofeedback · Intervention Types: OtherTrial 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 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
- Beck, Aaron T., David Guth, Robert A. Steer, and Roberta Ball. 1997. “Screening for Major Depression Disorders in Medical Inpatients with the Beck Depression Inventory for Primary Care”. Behaviour Research and Therapy. Elsevier BV. doi:10.1016/s0005-7967(97)00025-9.
- Briere, John, Frank W. Weathers, and Marsha Runtz. 2005. “Is Dissociation a Multidimensional Construct? Data from the Multiscale Dissociation Inventory”. Journal of Traumatic Stress. Wiley. doi:10.1002/jts.20024.
- Lovibond, P.F., and S.H. Lovibond. 1995. “The Structure of Negative Emotional States: Comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories”. Behaviour Research and Therapy. Elsevier BV. doi:10.1016/0005-7967(94)00075-u.
- Hopper, J. W., Frewen, P. A., Sack, M., Lanius, R. A., & van der Kolk, B. A. (2007). The responses to Script-Driven Imagery Scale (RSDI): Assessment of state posttraumatic symptoms for psychobiological and treatment research. Journal of Psychopathology and Behavioral Assessment, 29(4), 249-268. https://doi.org/10.1007/s10862-007-9046-0
- Mehling, Wolf E., Cynthia Price, Jennifer J. Daubenmier, Mike Acree, Elizabeth Bartmess, and Anita Stewart. 2012. “The Multidimensional Assessment of Interoceptive Awareness (MAIA)”. Edited by Manos Tsakiris. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0048230.
- American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596
- Ros, Tomas, Bernard J. Baars, Ruth A. Lanius, and Patrik Vuilleumier. 2014. “Tuning Pathological Brain Oscillations with Neurofeedback: A Systems Neuroscience Framework”. Frontiers in Human Neuroscience. Frontiers Media SA. doi:10.3389/fnhum.2014.01008.
- Weathers, Frank W., Michelle J. Bovin, Daniel J. Lee, Denise M. Sloan, Paula P. Schnurr, Danny G. Kaloupek, Terence M. Keane, and Brian P. Marx. 2018. “The Clinician-administered PTSD Scale for DSM–5 (CAPS-5): Development and Initial Psychometric Evaluation in Military Veterans.”. Psychological Assessment. American Psychological Association (APA). doi:10.1037/pas0000486.
- Bernstein, David P, Judith A Stein, Michael D Newcomb, Edward Walker, David Pogge, Taruna Ahluvalia, John Stokes, et al.. 2003. “Development and Validation of a Brief Screening Version of the Childhood Trauma Questionnaire”. Child Abuse & Neglect. Elsevier BV. doi:10.1016/s0145-2134(02)00541-0.
- Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The ptsd checklist for dsm-5 (pcl-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 10(4), 206.
- Blevins, Christy A., Frank W. Weathers, Margaret T. Davis, Tracy K. Witte, and Jessica L. Domino. 2015. “The Posttraumatic Stress Disorder Checklist for dsm-5 (PCL-5): Development and Initial Psychometric Evaluation”. Journal of Traumatic Stress. Wiley. doi:10.1002/jts.22059.
- Sitaram, Ranganatha, Tomas Ros, Luke Stoeckel, Sven Haller, Frank Scharnowski, Jarrod Lewis-Peacock, Nikolaus Weiskopf, et al.. 2016. “Closed-loop Brain Training: The Science of Neurofeedback”. Nature Reviews Neuroscience. Springer Science and Business Media LLC. doi:10.1038/nrn.2016.164.
- Nicholson, Andrew A., Daniela Rabellino, Maria Densmore, Paul A. Frewen, David Steyrl, Frank Scharnowski, Jean Théberge, et al.. 2021. “Differential Mechanisms of Posterior Cingulate Cortex Downregulation and Symptom Decreases in Posttraumatic Stress Disorder and Healthy Individuals Using Real‐time Fmri Neurofeedback”. Brain and Behavior. Wiley. doi:10.1002/brb3.2441.
- Nicholson, Andrew A., Daniela Rabellino, Maria Densmore, Paul A. Frewen, Christian Paret, Rosemarie Kluetsch, Christian Schmahl, et al.. 2016. “The Neurobiology of Emotion Regulation in Posttraumatic Stress Disorder: Amygdala Downregulation via Real‐time Fmri Neurofeedback”. Human Brain Mapping. Wiley. doi:10.1002/hbm.23402.
- Perasso, Giulia & Velotti, Patrizia. (2017). Difficulties in Emotion Regulation Scale. 10.1007/978-3-319-28099-8_810-1.
- Massoubre, C., H. Bonnefond, A. Grosselin, A. Nelva, J. Pellet, and F. Lang. 2009. “Étude préliminaire comparative de l’instrument d’évaluation des troubles de la personnalité DIP avec l’entretien semi-structuré SCID-II”. L'encéphale. Elsevier BV. doi:10.1016/j.encep.2008.09.007.
- Andrew Nicholson 2022. "Multi-session fMRI-Neurofeedback in PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05456958.
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