An interventional study of Neurofeedback in PTSD, Post-traumatic Stress Disorder and Cognitive Dysfunction, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Withdrawn at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-21.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment
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.
PTSD has an emotional impact on individuals, but it is also associated with impaired cognitive functioning (e.g., processing speed, attention, executive functioning). Unfortunately, there is little research investigating both issues simultaneously. The current study is an effectiveness trial for an intervention called neurofeedback (NFB), which may be helpful in addressing both PTSD symptom severity, and cognitive dysfunction. NFB is a type of brain training in which a person is given real-time information (or feedback) from their own brain activity to help them potentially change how their brain is functioning (i.e., to work in a healthier or more effective manner). NFB has been in use for over 30 years, and it is proven to be quite effective in treating ADHD (Attention Deficit Hyperactivity Disorder); however, it has not been embraced as a clinical intervention for other mental health disorders. Recent systematic reviews of NFB suggest that this treatment intervention can lead to significant clinical improvements (e.g., reduction in PTSD severity), and it can impact both functional brain activity and cognitive function. The current study hopes to bring these 3 areas of interest together by investigating the impact of NFB on PTSD symptoms, cognitive ability, and intrinsic neurological connectivity (via fMRI - function magnetic imaging).
In the current study, participants will be randomized into one of two conditions: NFB or Wait List. Those in the NFB condition will begin 19 weekly, supervised (via teleconferencing) sessions of NFB, while the Wait List will not receive NFB for approximately 31 weeks (i.e., not until final assessments are complete). After all assessments are complete, participants in the Wait List condition will be able to begin the same 19 sessions of NFB. Study participation includes pre-, post-, and 3-month follow-up assessments, and 2 optional fMRI scans. Due to the current coronavirus pandemic, this study will be conducted primarily online.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
Browse Stress Disorders, Traumatic studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
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Exclusion Criteria for those opting in to fMRI scan:
Exclusion Criteria for study in general:
Participants in the NFB condition will complete 19 weekly sessions of NFB from home with research staff supervision (via videoconferencing), and pre-, post- and 3-month follow-up assessments.
Other: Neurofeedback
Participants in the Wait List condition will receive no NFB for approximately 31 weeks, and will be asked to complete pre-, post- and 3-month follow-up assessments. After study completion, they will be offered the same 19 weeks of NFB.
NFB is a type of brain training in which a person is given real-time information (or feedback) from their own brain activities to help them potentially change how their brain is functioning (i.e., to work in a healthier or more effective manner). In the current study, we will implement at-home, supervised (via teleconferencing) neurofeedback sessions using the Muse headband paired with the Myndlift software application to conduct "alpha-down" neurofeedback once per week, for 19 weeks.
Also known as: EEG Biofeedback
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
Time frame: 19 weeks
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
Time frame: 12 weeks
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.
Time frame: 19 weeks
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.
Time frame: 12 weeks
Plan to share: No — Only coded data will be shared with co-investigators who are registered with the study's ethics board application.
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's