Trauma-Informed Goal Management Training for Individuals With Post-traumatic Stress Disorder (PTSD)

Demographic Information

Age, sex, race, education, relationship status, employment status, and profession.

Time frame: Collected at baseline only

Scores on the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('LEC-5') at baseline

A self-report measure designed to screen for potentially traumatic events in a respondent's lifetime by assessing exposure to 16 events known to potentially result in PTSD or distress, as well as one additional item to assess any other extraordinarily stressful event not captured in the first 16 items. There is no formal scoring protocol or interpretation, as this measure simply identifies whether a person has experienced one or more of the events listed.

Time frame: Administered at baseline only

Scores on the Childhood Trauma Questionnaire ('CTQ') at baseline

A self-report measure that assesses for exposure to five forms of common childhood trauma -- sexual abuse, physical abuse, emotional abuse, physical neglect, emotional neglect. All sub-scales (or, the five forms of childhood trauma) have a possible score range of 5 to 25. Higher scores reflect greater exposure to childhood trauma.

Time frame: Administered at baseline only

Scores on the Advanced Clinical Solutions ('ACS') Test of Premorbid Functioning ('TOPF') at baseline

The Advanced Clinical Solutions (ACS) Test of Premorbid Functioning (TOPF) provides an estimate of pre-morbid intellectual functioning, and will be administered using Zoom for Healthcare (a PHIPA-compliant video conferencing platform). The test yields one raw score (total number of words correctly read before the discontinue criteria was met) that is converted to a T score. Higher T scores indicate better performance on this task.

Time frame: Administered at baseline only

Change from baseline in scores on the Mini International Neuropsychiatric Interview 7.0.2 ('M.I.N.I.') at post-intervention and follow-up

A structured clinician-administered interview that assesses psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition. Diagnostic modules utilised: i) Major Depressive Episode ii) Suicidality iii) Manic and Hypomanic Episodes iv) Panic Disorder v) Agoraphobia vi) Social Anxiety Disorder vii) Obsessive Compulsive Disorder viii) Alcohol Use Disorder ix) Substance Use Disorder x) Psychotic Disorders and Mood Disorder with Psychotic Features xi) Anorexia Nervosa xii) Bulimia Nervosa; xiii) Binge Eating Disorder xiv) Generalized Anxiety Disorder This is a diagnostic clinical interview; scores are not reported on a scale.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on selected neuropsychological assessment measures of Executive functioning, Processing speed and Attention at post-intervention and follow-up

The Double Trouble, Feature Match, Spatial Planning, and Odd One Out subtests of the 'Creyos' battery will be administered remotely using Zoom for Healthcare (a PHIPA-compliant video conferencing platform) and 'Creyos' (a web-based platform for assessing cognitive functioning) to assess executive functioning, processing speed, and attention. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores may indicate greater performance on these tasks. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on the California Verbal Learning Test (CVLT-3) at post-intervention and follow-up

The California Verbal Learning Test (CVLT-3, standard and alternate forms) will be administered over PHIPA-compliant video conferencing as an assessment of declarative memory. Scaled scores (mean=10, SD=3), ranging between 1 and 19, and corresponding percentile ranks, are derived from the individual's raw scores to indicate where the individual's scores fall on a normal distribution. Higher scores on correctly recalled items indicate greater performance on these tasks; higher scores in recall errors may reflect greater deficits.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on selected neuropsychological assessment measures of Declarative memory at post-intervention and follow-up

Declarative memory will also be assessed using the Paired Associates and Digit Span subtests of the 'Creyos' battery (a web-based platform for assessing cognitive functioning) over PHIPA-compliant video conferencing. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores on correctly recalled items indicate greater performance on these tasks; higher scores in recall errors may reflect greater deficits. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on selected neuropsychological assessment measures of Intellectual functioning at post-intervention and follow-up

The Grammatical Reasoning subtest of the 'Creyos' Battery will be administered remotely using PHIPA-compliant video conferencing and 'Creyos' (a web-based platform for assessing cognitive functioning) as an assessment of the ability to quickly understand and make valid conclusions about concepts expressed in words. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores may indicate greater performance on these tasks. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on selected neuropsychological assessment measures of Visuospatial and Visuoconstructive Ability and Sensorimotor integration at post-intervention and follow-up

The Rotations (mental manipulation of visual stimuli) and Polygons (visuospatial processing) subtests of the 'Creyos' Battery will be administered remotely using PHIPA-compliant video conferencing and 'Creyos' (a web-based platform for assessing cognitive functioning) to assess visuospatial and visuoconstructive ability and sensorimotor integration. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores may indicate greater performance on these tasks. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on selected neuropsychological assessment measures of Visual and Visuospatial Working Memory at post-intervention and follow-up

Token Search (visual working memory), Monkey Ladder (visuospatial working memory), and Spatial Span (spatial short-term memory) subtests of the 'Creyos' Battery will be administered remotely using PHIPA-compliant video conferencing and 'Creyos' (a web-based platform for assessing cognitive functioning) to assess visual and visuospatial working memory. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores may indicate greater performance on these tasks. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in score on the Depression and Anxiety Stress Scale ('DASS-21') at post-intervention and follow-up

A self-report measure that assesses the presence and severity of symptoms of depression, anxiety, and stress over the last week. Respondents rate their symptoms on a 4-point scale with 0 representing absence of the symptom and 3 representing a symptom occurring almost all the time. Three scores are computed, one for each sub-scale (depression, anxiety, and stress), by summing all the values of the items on each respective sub-scale. Higher scores reflect greater symptom severity; calculated scores can be used to qualify the severity of the symptoms (e.g., normal/minimal, mild, moderate, severe, extremely severe).

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in score on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('PCL-5') at post-intervention and follow-up

A 20-item self-report measure that assesses the severity of PTSD symptoms according to the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders-5th Edition. Symptom domains are intrusions, avoidance, negative alterations in mood and cognitions, and alterations in arousal and reactivity. A total score, ranging between 0 and 80, is derived by summing all the values of the items, and a cut-off point of 33 is suggested to indicate a probable PTSD diagnosis.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in score on the Multiscale Dissociation Inventory ('MDI') at post-intervention and follow-up

A 30-item self-report measure that assesses six domains of dissociative symptoms over the past month -- disengagement, depersonalisation, derealisation, emotional constriction, memory disturbance, and identity dissociation. A total score, ranging between 30 and 150, is derived by summing all the values of the items; higher total scores indicate greater dissociation.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in score on the Difficulties in Emotion Regulation Scale ('DERS') at post-intervention and follow-up

A 36-item self-report measure that assesses difficulties with emotion regulation across six domains -- nonacceptance of emotional responses, difficulty engaging in goal-directed behaviour, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Higher scores may indicate greater dysfunction in emotion regulation.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in score on the twenty-item Toronto Alexithymia Scale ('TAS-20') at post-intervention and follow-up

A 20-item self-report measure that assesses difficulties recognising and naming emotions across three domains -- difficulty identifying feelings, difficulty describing feelings, and externally oriented thinking. Individuals with scores less than or equal to 51 are interpreted as having no alexithymia, individuals with scores between 52 and 60 are interpreted as having possible alexithymia, and individuals with scores greater than or equal to 61 are interpreted as having alexithymia.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in score on the Moral Injury Outcome Scale ('MIOS-F') at post-intervention and follow-up

The Moral Injury Outcome Scale - Full (MIOS-F) is a self-report measure designed to assess psychosocial outcomes associated with exposure to potentially morally injurious events (PMIEs). This measure includes an initial assessment of exposure to PMIEs, determination of whether the most distressing event meets Criterion A for trauma, and 14 items assessing moral injury-related outcomes over the past month, rated on a 5-point Likert scale, yielding a total score (0-56). Higher scores indicate greater moral injury severity.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) at post-intervention and follow-up

A 75-item standardised self-report measure that captures an individual's views of their executive functions or self-regulation in their everyday environment across nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organise, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organisation of Materials. Responses to items are summed up to generate raw scores, which are then converted to T scores. Higher T scores typically reflect greater difficulties in the corresponding aspects of executive dysfunction.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention and follow-up

A 15-item self-report measure that captures subjective experiences of cognitive failures in daily life. Each item is rated on a Likert scale from 0 ("Never") to 4 ("Very often"). Higher scores may indicate greater self-reported impairment in cognitive functioning.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on the Return to work Obstacles and Coping Efficacy - Common Mental Disorders ('ROSES-CMD') at post-intervention and follow-up

Evaluates obstacles participants may face when returning to work (part A) and how capable they feel they are of overcoming them (part B). Items use a 7-point response scale and include specific questions to assess perceived obstacles and self-efficacy beliefs about overcoming the obstacles. Higher scores on 'obstacles' items and lower scores on 'self-efficacy' items indicate decreased readiness to return-to-work.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on the World Health Organization's Disability Assessment Schedule ('WHODAS 2.0') at post-intervention and follow-up

A 36-item self-report measure that assesses health and disability on six domains of functioning: cognition, mobility, self-care, getting along (interacting with others), life activities, and participation (participating in society). Higher values may indicate greater functional impairment.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on the Lam Employment Absence and Productivity Scale ('LEAPS') at post-intervention and follow-up

A self-report measure designed to assess and monitor work functioning and productivity. Participants are asked to respond to 4 questions; the fourth question assesses specific symptoms by having participants respond to 7 sub-questions on a 5-point scale. Two values of interest for this study are derived: i) measure of work impairment (sum of responses to the 7 sub-questions) ii) percent of work hours missed due to impairment \[raw score of item 3 (hours of work missed) divided by raw score of item 2 (hours of work scheduled) multiplied by 100\]. A total score, ranging from 0-28, is derived by summing responses to the 7 sub-questions; higher scores indicate greater work impairment.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up

Change from baseline in scores on the Survey of Perceived Organizational Support ('SPOS') at post-intervention and follow-up

An 8-item survey that assesses the extent to which an individual believes that their organisation is 1. committed to them, 2. values their continued membership, and 3. is generally concerned about their well-being.

Time frame: Baseline, post-intervention at 9 weeks, and 3-month follow-up