Accelerated Neuromodulation for Concurrent Post-Traumatic Stress Disorder (PTSD) & Chronic Pain in Veterans

The PCL-5 is a 20-item self-report checklist of Post-Traumatic Stress Disorder (PTSD) symptoms based closely on the DSM-5 criteria. Respondents rate each item from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month (or past week if using the PCL-5 weekly). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms. A score greater than 33 is typically used to indicate severity sufficient for a PTSD diagnosis

The CPGS assesses two dimensions of overall chronic pain severity: pain intensity and pain-related disability. It is suitable for use in all chronic pain conditions. Participants must score 'Grade I, II, or III' on the CPGS at screening to qualify for the study. Each questions is scored using a 11-point Likert scale. Total scores range from 0 to 30, with higher scores indicating more pain.

The PDI is designed to measure the degree to which aspects of a participant's life are disrupted by chronic pain. In other words, how much pain is preventing them from doing what they would normally do or from doing it as well as they normally would. Participants will be asked to respond to each category indicating the overall impact of pain in their life, not just when pain is at its worst. The total PDI score can range from 0 to 70, a higher score indicating more disruption with functioning across a range of activities.

The Hamilton Depression Rating Scale (HAM-D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).

The PHQ-9 is a 9-item self-report questionnaire used to assess depression symptom severity. Depression symptoms are rated from 0 (not depression) to 27 (severe).

The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 (no anxiety) to 56 (severe anxiety)

The General Anxiety Disorder scale is a 7-item questionnaire used to measure symptoms of generalized anxiety disorder. Scores range from 0-21 with higher scores indicating more generalized anxiety

The IPF is a self-report instrument measuring PTSD-related functional impairment experienced by Veterans. Respondents rate how often they have acted a certain way over the past 30 days. The IPF was developed to have high content validity, to not confound PTSD symptoms and related impairment, and to not require respondent attributions regarding the cause of impairment. Items are rated on a 7-point scale ranging from 0 ("never") to 6 ("always"). The IPF yields a total score (0-66) and scores for seven subscales: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care functioning (lower indicates better functioning/less impairment). Higher scores indicate more impairment

Cognitive function, specifically executive functioning, processing speed, episodic memory, and working memory, will be assessed using the ReadON Cognitive Test (Orange Neurosciences, Kingston, ON, Canada). Unlike standardized paper tests with a single total score, the ReadON test uses an algorithm to provide a comprehensive profile across multiple cognitive domains.

NeuroCatch® Platform (NCP; NeuroCatch Inc., Surrey, BC, Canada) will be used to complement as an objective measure of cognitive function. NCP is an easy-to-use, objective, rapid neuro-physiological brain function assessment system, licensed by Health Canada as a Class II medical device. The platform provides acquisition, display, analysis, storage, reporting, and management of EEG and event related potential (ERP) information including the N100, P300 and N400 measures of brain function

Efficacy/effectiveness will be assessed using results from the clinician- and participant-reported Post-Traumatic Stress Disorder (PTSD) and chronic pain symptoms measured as primary outcome measures (PCL-5 and CPGS), comparing changes from baseline to end of treatment (end of week 1).

Adoption will be assessed as the perceived ease of protocol administration (for clinicians) and program adherence (for participants).

Implementation and maintenance will be assessed upon qualitative reports from the study team and participants regarding barriers and facilitators to help inform future program implementation efforts

Reach will be assessed as the proportion of participants screened who are eligible for the study, reason(s) for ineligibility, number of withdrawals/dropouts, barriers to participation reported by participants.