PTSD Clinical Trial
Official title:
An Effectiveness Trial Examining Neurofeedback in Adults With PTSD
Verified date | March 2021 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is an effectiveness trial investigating neurofeedback (NFB) in adults with PTSD (Post-Traumatic Stress Disorder). Participants will be randomly assigned to one of two treatment conditions - i) NFB, or ii) wait list. Due to the coronavirus pandemic, our study will, primarily, take place online (i.e., online assessment and treatment, with option of in-person fMRI, or functional magnetic resonance imaging, scans). NFB sessions will be conducted from home, with videoconferenced supervision by research staff. After study completion, individuals in the wait list condition will be offered the same NFB treatment.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - primary diagnosis of PTSD as determined by our pre-treatment assessment - Due to online nature: must have access to (and ability to use) a computer/tablet with a working microphone and camera (or webcam) for assessments, and a tablet/smartphone for NFB, reliable access to a secure internet connection, and access to a quiet, private space for the assessments and sessions. - Ability to provide informed consent - Fluency in written and spoken English - must be resident of Ontario (due to restrictions of professional licenses) Exclusion Criteria for those opting in to fMRI scan: - any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy) Exclusion Criteria for study in general: - history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score < 15 at the time of incident as assessed retrospectively by participant) - significant untreated medical illness - history of neurological or neurodevelopmental disorder - history of any pervasive developmental disorder - any medical disorder known to adversely affect cognition within the last 12 months - lifetime bipolar or psychotic disorder - alcohol/substance abuse or dependence within the last 3 months - extensive narcotic use (e.g., fentanyl, oxycodone, etc.), use of anti-cholinergics, anti-psychotics, psychostimulants, or benzodiazepines - ECT (electroconvulsive therapy) within the last 12 months - significant dissociative disorder (as determined by our baseline assessment) - suicide attempt in last 6 months - pregnancy (due to impact of hormones on cognitive abilities) - hearing or vision issues that would interfere with effective online participation: |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | FDC Foundation, McMaster University |
Canada,
Kluetsch RC, Ros T, Théberge J, Frewen PA, Calhoun VD, Schmahl C, Jetly R, Lanius RA. Plastic modulation of PTSD resting-state networks and subjective wellbeing by EEG neurofeedback. Acta Psychiatr Scand. 2014 Aug;130(2):123-36. doi: 10.1111/acps.12229. Epub 2013 Nov 25. — View Citation
Nicholson AA, Rabellino D, Densmore M, Frewen PA, Paret C, Kluetsch R, Schmahl C, Théberge J, Ros T, Neufeld RWJ, McKinnon MC, Reiss JP, Jetly R, Lanius RA. Intrinsic connectivity network dynamics in PTSD during amygdala downregulation using real-time fMRI neurofeedback: A preliminary analysis. Hum Brain Mapp. 2018 Nov;39(11):4258-4275. doi: 10.1002/hbm.24244. Epub 2018 Jul 13. — View Citation
Nicholson AA, Ros T, Densmore M, Frewen PA, Neufeld RWJ, Théberge J, Jetly R, Lanius RA. A randomized, controlled trial of alpha-rhythm EEG neurofeedback in posttraumatic stress disorder: A preliminary investigation showing evidence of decreased PTSD symptoms and restored default mode and salience network connectivity using fMRI. Neuroimage Clin. 2020;28:102490. doi: 10.1016/j.nicl.2020.102490. Epub 2020 Nov 5. — View Citation
Rogel A, Loomis AM, Hamlin E, Hodgdon H, Spinazzola J, van der Kolk B. The impact of neurofeedback training on children with developmental trauma: A randomized controlled study. Psychol Trauma. 2020 Nov;12(8):918-929. doi: 10.1037/tra0000648. Epub 2020 Jul 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment. | Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms | 19 weeks | |
Primary | Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment. | Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms | 12 weeks | |
Primary | Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment | A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance. | 19 weeks | |
Primary | Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment | A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance. | 12 weeks |
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