Neurofeedback Effectiveness Trial in PTSD

Not Applicable

Withdrawn

• Conditions: PTSD; Post-traumatic Stress Disorder; Cognitive Dysfunction; Cognitive Deficit
• Interventions: Other: Neurofeedback

• Registration Number: NCT04654130
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-12-04
• Status Verified: 2021-03
• Study Start: 2022-02-01
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-21
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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:

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neurofeedback (NFB)	Neurofeedback	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.

Primary Outcome Measures

Name	Time	Method
Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.	12 weeks	Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment.	19 weeks	Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms
Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment	12 weeks	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.
Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment	19 weeks	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.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada