Investigating the Use of Goal Management Therapy in Improving Cognitive Functioning in Public Safety Personnel With PTSD

Study Overview
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Brief Summary
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This study examines the efficacy of Goal Management Therapy (GMT)--a well-established cognitive remediation strategy, aimed at improving goal-directed behaviors that are dependent on basic cognitive processes and on executive functioning, among public safety personnel with post-traumatic stress disorder.

Detailed Description
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Goal Management Therapy is a structured, short-term, present-oriented cognitive remediation program with an emphasis on mindfulness and practice in planning and completion of goal-oriented behaviors. The primary objective of GMT is to train participants to interrupt ongoing behavior through the resumption of executive control in order to define goal hierarchies and monitor performance in achieving goals. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments. The matched psychosocial education control group will focus on educational materials (e.g. brain function, neuroplasticity), and lifestyle interventions (e.g. sleep hygiene, stress, exercise.) The study will take place in two phases: phase 1 will consist of 6 sessions of Goal Management Therapy and 6 sessions of psychosocial education among public safety personnel and civilians who are inpatients at a mental health and addiction facility. Phase 2 will consist of 9 sessions of Goal Management Therapy and 9 sessions of psychosocial education, among public safety personal who are members of the local community.

Official Title
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A Randomized Control Trial Examining the Treatment Efficacy of a Novel Approach to Cognitive Remediation in Public Safety Personnel With Post-traumatic Stress Disorder (PTSD) and Co-morbid Conditions

Conditions
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Post Traumatic Stress Disorder, Cognitive Deficit

Intervention / Treatment
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* Behavioral: Goal Management Therapy
* Behavioral: Psychosocial Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a diagnosis of post-traumatic stress disorder on the Clinician Administered PTSD Scale (CAPS) are able to provide written informed consent Exclusion Criteria: receiving treatment with anti-cholinergics, anti-psychotic medication, or psychostimulants use of benzodiazepines within the last 24 hours have had Electroconvulsive therapy within the past year a diagnosis of substance dependence or abuse within the past 6 months a recent history (within the past 12 months) of medical disorder known to adversely affect cognition a history of head trauma with more than one minute of loss of consciousness or a history of traumatic brain injury a history of neurological disorder a diagnosis of psychotic disorder or bipolar disorder a history of a neurodevelopmental disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants assigned to the experimental group (Goal Management Therapy) will receive either 6 (phase 1) or 9 (phase 2) group therapy sessions. The matched control group (psychosocial education) will receive an equal number of group therapy sessions. Each session will be 2 hours long.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal Management Therapy<br>Goal Management Therapy is a structured, short-term, present-oriented cognitive remediation program with emphasis on mindfulness and practice in planning and completion of goal-oriented behaviors. The primary objective of GMT is to train patients to interrupt ongoing behavior through the resumption of executive control in order to define goal hierarchies and monitor performance in achieving goals. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments. Phase 1: Inpatients will attend group sessions twice per week for 3 weeks, each session being 2 hours in length. Phase 2: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length. | Behavioral: Goal Management Therapy<br>* A cognitive training program aimed at improving cognitive deficits such as in memory, attention, learning, and executive functioning.<br>* Other names: Goal Management Training;|
| Active Comparator: Psychosocial Education<br>Psychosocial education will provide educational materials (e.g., brain function, neuroplasticity) and lifestyle interventions (e.g., sleep hygiene, stress, exercise). They will be matched for length and for amount of facilitator contact with the Goal Management Therapy sessions. Phase 1: Inpatients will attend group sessions twice per week for 3 weeks, each session being 2 hours in length. Phase 2: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length. | Behavioral: Psychosocial Education<br>* A group therapy program focusing on brain function, neuroplasticity, and lifestyle interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score on Delis-Kaplan Executive Function System (D-KEFS) Tower Test | A neuropsychological assessment of planning, rule learning, response inhibition, and perseveration. Six scores are calculated: i) Total Achievement Score, which is the sum of achievement scores for all items administered. ii) Mean First-Move Time which reflects the average of the examinee's first move times. iii) Time-Per-Move Ratio, which indicates the average time the examinee takes to make each of his or her moves. iv) Move Accuracy Ratio is a means of assessing the efficiency with which the examinee constructed the towers. v) Total Rule Violations represents the total number of rule violations committed by the examinee across all items administered. vi) Rule-Violations-Per Item Ratio, reflects the average number of rule violations made by the examinee relative to the number of items administered. The total number of rule violations across all items administered is divided by the number of items administered. Higher scores indicate greater executive functioning performance. | Phase 1 (inpatient): baseline and post-intervention at 3 weeks | 
| Change in Score on Delis-Kaplan Executive Function System (D-KEFS) Tower Test | A neuropsychological assessment of planning, rule learning, response inhibition, and perseveration. Six scores are calculated: i) Total Achievement Score, which is the sum of achievement scores for all items administered. ii) Mean First-Move Time which reflects the average of the examinee's first move times. iii) Time-Per-Move Ratio, which indicates the average time the examinee takes to make each of his or her moves. iv) Move Accuracy Ratio is a means of assessing the efficiency with which the examinee constructed the towers. v) Total Rule Violations represents the total number of rule violations committed by the examinee across all items administered. vi) Rule-Violations-PerItem Ratio, reflects the average number of rule violations made by the examinee relative to the number of items administered. The total number of rule violations across all items administered is divided by the number of items administered. Higher scores indicate greater executive functioning performance. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in Score on Wechsler Adult Intelligence Scale-IV (WAIS-IV), Coding Subtest | A neuropsychological assessment of processing speed. In a time limit of 120 seconds, the participant copies symbols that are paired with numbers based on a symbol key. The total raw score is calculated by scoring 1 point for each correctly drawn symbol completed within the time limit. Raw scores range between 0 and 135 points. The raw score is converted to a scaled score corrected for age and the scaled score may range between 1 and 19. Higher scaled scores indicate greater processing speed than lower scaled scores. | Phase 1 (inpatient): baseline and post-intervention at 3 weeks | 
| Change in Score on Wechsler Adult Intelligence Scale-IV (WAIS-IV), Coding Subtest | A neuropsychological assessment of processing speed. In a time limit of 120 seconds, the participant copies symbols that are paired with numbers based on a symbol key. The total raw score is calculated by scoring 1 point for each correctly drawn symbol completed within the time limit. Raw scores range between 0 and 135 points. The raw score is converted to a scaled score corrected for age and the scaled score may range between 1 and 19. Higher scaled scores indicate greater processing speed than lower scaled scores. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in Score on Conners Continuous Performance Task Third Edition (CPT-III) | A neuropsychological assessment of inattentiveness, impulsivity, sustained attention, and vigilance. Values include: i) D-prime-discrimination of non targets from targets; ii) Omissions- all missed targets; iii) Commissions- all incorrect responses to non-targets; iv) Perseverations- response in less than 100 milliseconds following the presentation of a stimulus; v) Hit Reaction Time- mean response speed measured in milliseconds for all non-perseverative responses made during the entire administration; vi) Hit Reaction Time SD-consistency of response speed to targets for the entire administration; vii) Variability- response speed consistency; viii) Hit Reaction Time Block Change- slope of change in Hit Reaction Time across the six blocks of the administration; and ix) Hit Reaction Time Inter-Stimulus Interval Change slope of change in reaction time across the three inter-stimulus intervals. All scores are presented in T scores with higher T scores indicating worse performance. | Phase 1 (inpatient): baseline, and post-intervention at 3 weeks | 
| Change in Score on Conners Continuous Performance Task Third Edition (CPT-III) | A neuropsychological assessment of inattentiveness, impulsivity, sustained attention, and vigilance. Values include: i) D-prime-discrimination of non targets from targets; ii) Omissions- all missed targets; iii) Commissions- all incorrect responses to non-targets; iv) Perseverations- response in less than 100 milliseconds following the presentation of a stimulus; v) Hit Reaction Time- mean response speed measured in milliseconds for all non-perseverative responses made during the entire administration; vi) Hit Reaction Time SD-consistency of response speed to targets for the entire administration; vii) Variability- response speed consistency; viii) Hit Reaction Time Block Change- slope of change in Hit Reaction Time across the six blocks of the administration; and ix) Hit Reaction Time Inter-Stimulus Interval Change slope of change in reaction time across the three inter-stimulus intervals. All scores are presented in T scores with higher T scores indicating worse performance. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in score on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | The WHODAS 2.0 is a 12-item self-report measure of six functional domains, including cognition, mobility, self-care, getting along with others, life activities, and participation in the community. The WHODAS 2.0 uses a Likert scale ranging from 0 (No difficulty) to 4 (Extreme difficulty or cannot do). Values across the 12 items are summed, with the total score ranging between 0 and 48. Higher values indicate greater functional impairment. | Phase 1 (inpatient): baseline, post-intervention at 3 weeks, 3 months post-intervention | 
| Change in score on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | The WHODAS 2.0 is a 12-item self-report measure of six functional domains, including cognition, mobility, self-care, getting along with others, life activities, and participation in the community. The WHODAS 2.0 uses a Likert scale ranging from 0 (No difficulty) to 4 (Extreme difficulty or cannot do). Values across the 12 items are summed, with the total score ranging between 0 and 48. Higher values indicate greater functional impairment. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in score on the Sheehan Disability Scale (SDS) | The SDS is a 3-item self-report measure of disability in work, social relationships, and family life. The three items, which are scored on a Likert scale between 0 and 10, are summed into a single dimensional measure of global functional impairment. The SDS total score may range from 0 to 30, with higher scores indicating greater impairment. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in score on the Cognitive Failures Questionnaire (CFQ) | The CFQ is a 25-item self-report measure that captures daily errors in distractibility, blunders, names, and memory. Each item is rated on a Likert scale from 0 (Never) to 4 (Very often). The CFQ has four subscales that include: i) Memory (i.e., sum of scores on items 16, 18, 12, 17, 23, 13, 6, 3 for a total score between 0 and 32); ii) Distractibility (i.e., sum of scores on items 1, 15, 2, 19, 21, 22, 3, 4, 25 for a total score between 0 and 36); iii) Blunders (i.e., sum of scores on items 9, 8, 10, 24, 5, 14, 11 for a total score between 0 and 28); and iv) Names (i.e., sum of scores on items 20 and 7 for a total score between 0 and 8). The CFQ total score is the sum of the 25 items, with total values ranging between 0 and 100. Higher scores indicate greater self-reported impairment in cognitive functioning. | Phase 1 (inpatient): baseline, post-intervention at 3 weeks, 3 months post-intervention. This measure will also be administered during week 1, week 3, week 6, and week 9 of the intervention. | 
| Change in score on the Cognitive Failures Questionnaire (CFQ) | The CFQ is a 25-item self-report measure that captures daily errors in distractibility, blunders, names, and memory. Each item is rated on a Likert scale from 0 (Never) to 4 (Very often). The CFQ has four subscales that include: i) Memory (i.e., sum of scores on items 16, 18, 12, 17, 23, 13, 6, 3 for a total score between 0 and 32); ii) Distractibility (i.e., sum of scores on items 1, 15, 2, 19, 21, 22, 3, 4, 25 for a total score between 0 and 36); iii) Blunders (i.e., sum of scores on items 9, 8, 10, 24, 5, 14, 11 for a total score between 0 and 28); and iv) Names (i.e., sum of scores on items 20 and 7 for a total score between 0 and 8). The CFQ total score is the sum of the 25 items, with total values ranging between 0 and 100. Higher scores indicate greater self-reported impairment in cognitive functioning. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in score on the Dysexecutive Questionnaire (DEX) | The DEX is a 20-item self-report measure that asks participants to rate inhibition, positive and negative affect, memory, and intention. Each item is rated on a Likert scale from 0 (Never) to 4 (Very often). The DEX Total score is the sum of all items and the total score may range from 0 to 80. Higher scores indicate greater self-reported cognitive impairment. | Phase 1 (inpatient): baseline, post-intervention at 3 weeks, 3 months post-intervention | 
| Change in score on the Dysexecutive Questionnaire (DEX) | The DEX is a 20-item self-report measure that asks participants to rate inhibition, positive and negative affect, memory, and intention. Each item is rated on a Likert scale from 0 (Never) to 4 (Very often). The DEX Total score is the sum of all items and the total score may range from 0 to 80. Higher scores indicate greater self-reported cognitive impairment. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in Score on the Return to Work Obstacles and Self-Efficacy Scale- Common Mental Disorders (ROSES-CMD) | A 46-item questionnaire that assesses readiness to return to work in individuals with common mental disorders on 10 possible dimensions: fears of a relapse, cognitive difficulties, medication-related difficulties, job demands, feeling of organization injustice, difficult relation-immediate supervisor, difficult relations-co-workers, difficult relations-insurance company, difficult work/life balance, and loss of motivation to return to work. Items use a 7-point response scale and include specific questions to assess perceived obstacles (1=not an obstacle, 7=Big obstacle) and self-efficacy beliefs about overcoming the obstacles (1=not at all capable, 7=completely capable). Higher scores on 'obstacles' items and lower scores on 'self-efficacy' items indicate decreased readiness to return-to-work. | Phase 1 (inpatient): baseline, and post-intervention at 3 weeks | 
| Change in Score on the Return to Work Obstacles and Self-Efficacy Scale- Common Mental Disorders (ROSES-CMD) | A 46-item questionnaire that assesses readiness to return to work in individuals with common mental disorders on 10 possible dimensions: fears of a relapse, cognitive difficulties, medication-related difficulties, job demands, feeling of organization injustice, difficult relation-immediate supervisor, difficult relations-co-workers, difficult relations-insurance company, difficult work/life balance, and loss of motivation to return to work. Items use a 7-point response scale and include specific questions to assess perceived obstacles (1=not an obstacle, 7=Big obstacle) and self-efficacy beliefs about overcoming the obstacles (1=not at all capable, 7=completely capable). Higher scores on 'obstacles' items and lower scores on 'self-efficacy' items indicate decreased readiness to return-to-work. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in Score on Lam's Employment and Productivity Scale (LEAP) | The LEAP is a self-report measure designed to assess and monitor work functioning and productivity. Participants are asked to respond to 4 questions, with the fourth question having 7 sub-questions assessing specific symptoms by having participants respond on a 5-point scale (0=none of the time, 4=all of the time). Two values of interest for this study are derived: i) measure of work impairment (responses to item 4's sub-questions are summed), 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. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in Score on The Hopkins Verbal Learning Test- Revised (HVLT-R) | A word list neuropsychological assessment, which provides indices of immediate and delayed memory performance, and recognition. The HVLT-R is scored quickly by hand using manualized procedures, which computes all raw scores and T scores, corrected for the examinee's age. Values of interest within the study include: i) Level of Immediate Recall; ii) Level of Delayed Recall, iii) Retention rate, iv) Delayed Recognition, and v) Recognition Errors. In general, higher T scores indicate intact performance; however, in other cases (e.g., Recognition Errors) higher T scores reflect greater deficits. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in Score on the VOT Hooper Visual Organization Test | A neuropsychological assessment of visual integration, the VOT requires individuals to identify common object that have been fragmented by mentally rearranging fragments of the object presented on a card, with a total of 30 cards. The VOT is scored by hand to obtain a single raw score, which is then corrected based on age and level of education. The corrected raw score is used to derive a T score, which is the value of interest. Higher T scores reflect better performance. | Phase 1 (inpatient): baseline and post intervention at 3 weeks. | 
| Change in Score on the VOT Hooper Visual Organization Test | A neuropsychological assessment of visual integration, the VOT requires individuals to identify common object that have been fragmented by mentally rearranging fragments of the object presented on a card, with a total of 30 cards. The VOT is scored by hand to obtain a single raw score, which is then corrected based on age and level of education. The corrected raw score is used to derive a T score, which is the value of interest. Higher T scores reflect better performance. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in Score on the Right-Left Orientation (RLO) Test | A neuropsychological assessment in which a series of 20 commands are presented to participants and they must identify the left or right hand, ear, eye, or shoulder on their own body or on the body of another person (e.g., show me your right hand). The test has four levels of difficulty and begins with the most difficult level, descending in difficulty each time the participant performs incorrectly. The test assesses individuals' right-left orientation to their own body, towards a confronting person, and combined orientation towards one's own body and a confronting person. The value of interest in this study is the raw score, which is computed by summing the responses to individual items (0 for an incorrect response and 1 for a correct response), with a possible score ranging from 0 to 20. A score less than 17 is considered a defective left-right orientation. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in Score on the Finger Localization Test | A neuropsychological assessment that asks participants to identify which finger is being touched under three conditions: i) with their hand visible, ii) with their hand hidden (i.e., eyes closed), and iii) with their hand hidden and with two fingers touched simultaneously. This test provides a measure of finger dysgnosia. It contains 60 items (30 per hand) and a total score can be computed by summing the number of correct responses (score of 1 for correct, 0 for incorrect) for each hand or across all items. The values of interest are the total raw scores and the corresponding percentile rank, which is determined by consulting the appropriate reference manual. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in Score on the Rey Osterrieth Complex Figure Task (ROCF) | A neuropsychological test in which participants are required to copy a complex drawing to provide insight into individuals visuospatial/visuoconstructive abilities and areas of executive functioning (e.g., planning, organization). A single raw score is computed by hand using a manualized procedure which is then converted to a T score. This computed T score is the value of interest for this study, with higher T scores reflecting better performance. | Phase 1 (inpatient): baseline and post-intervention at 3 weeks | 
| Change in Score on the Rey Osterrieth Complex Figure Task (ROCF) | A neuropsychological test in which participants are required to copy a complex drawing to provide insight into individuals visuospatial/visuoconstructive abilities and areas of executive functioning (e.g., planning, organization). A single raw score is computed by hand using a manualized procedure which is then converted to a T score. This computed T score is the value of interest for this study, with higher T scores reflecting better performance. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | 
| Change in score on the Depression Anxiety Stress Scale (DASS-21) | The DASS-21 is 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 subscale (depression, anxiety, and stress), by summing all the values of the items on each respective subscale. The total scores for each subscale are then multiplied by 2. Higher scores reflect greater symptom severity and the calculated scores can be used to qualify the severity of the symptoms (e.g., normal/minimal, mild, moderate, severe, extremely severe). | Phase 1 (Inpatient): This measure will also be administered during week 1, week 3, week 6, and week 9 of the intervention. | 
| Change in score on the Depression Anxiety Stress Scale (DASS-21) | The DASS-21 is 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 subscale (depression, anxiety, and stress), by summing all the values of the items on each respective subscale. The total scores for each subscale are then multiplied by 2. Higher scores reflect greater symptom severity and the calculated scores can be used to qualify the severity of the symptoms (e.g., normal/minimal, mild, moderate, severe, extremely severe). | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention. This measure will also be administered during week 1, week 3, week 6, and week 9 of the intervention. | 
| Change in Score on the STROOP Colour and Word Test | A neuropsychological test where individuals read colour words or names ink colors from different pages as quickly as possible within a time limit. It provides indices of processing speed and areas of executive functioning, such as cognitive flexibility, resistance to interference, and response inhibition. The test includes three stimulus sheets that yield three raw scores that are the number of words or ink colors read within the time limit (min = 0; no max score). Raw scores are converted to T scores using manualized procedures. Higher T scores indicate better performance. | Phase 1 (inpatient): baseline and post-intervention at 3 weeks | 
| Change in Score on the STROOP Colour and Word Test | A neuropsychological test where individuals read colour words or names ink colors from different pages as quickly as possible within a time limit. It provides indices of processing speed and areas of executive functioning, such as cognitive flexibility, resistance to interference, and response inhibition. The test includes three stimulus sheets that yield three raw scores that are the number of words or ink colors read within the time limit (min = 0; no max score). Raw scores are converted to T scores using manualized procedures. Higher T scores indicate better performance. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention. | 
| Change in Score on the Advanced Clinical Solutions Test of Premorbid Functioning (TOPF) | The TOPF is a word reading neuropsychological test that estimates an individual's level of cognitive and memory functioning before the onset of injury or illness. 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. | Phase 1 (inpatient): Administered at baseline only. | 
| Change in Score on the Advanced Clinical Solutions Test of Premorbid Functioning (TOPF) | The TOPF is a word reading neuropsychological test that estimates an individual's level of cognitive and memory functioning before the onset of injury or illness. 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. | Phase 2 (outpatient): Administered at baseline only. | 
| Change in Score on the Social Adjustment Scale- Self Report (SAS-SR) | SAS-SR is a 53-item questionnaire that assesses an individuals' level of satisfaction with his or her social situation in both instrumental (e.g., work) and expressive (e.g., recreational) role areas. Items are summed within each domain and divided by the number of scale items to derive domain and total scores. Raw scores are converted to gender-based standard scores (e.g., T scores and percentiles) with higher scores indicating higher levels of impairment (i.e., lower levels of social adjustment). | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic Information | Description: A self-report measure assessing demographic information including age, sex, race, education, marital status, employment status, and employment type (e.g., active military member, veteran, public safety personnel, first responder, or other). | Phase 1 (inpatient): administered at baseline only | 
| Demographic Information | Description: A self-report measure assessing demographic information including age, sex, race, education, marital status, employment status, and employment type (e.g., active military member, veteran, public safety personnel, first responder, or other). | Phase 2 (outpatient): administered at baseline only | 
| Mini International Neuropsychiatric Interview 7.0 (M.I.N.I.) | Description: The M.I.N.I. is a structured clinician administered interview in order to assess psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. The M.I.N.I. is divided into modules identified by letters, each corresponding to a diagnostic module. At the end of each module, diagnostic boxes permit the clinician to indicate whether diagnostic criteria are met. The diagnostic modules utilized within the study include: 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; and xiiii)Generalized Anxiety Disorder. | Phase 1 (inpatient): administered at baseline only | 
| Mini International Neuropsychiatric Interview 7.0 (M.I.N.I.) | Description: The M.I.N.I. is a structured clinician administered interview in order to assess psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. The M.I.N.I. is divided into modules identified by letters, each corresponding to a diagnostic module. At the end of each module, diagnostic boxes permit the clinician to indicate whether diagnostic criteria are met. The diagnostic modules utilized within the study include: 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; and xiiii)Generalized Anxiety Disorder. | Phase 2 (outpatient): administered at baseline only | 
| Childhood Trauma Questionnaire (CTQ) | A self-report measure, which assesses for exposure to five forms of common childhood trauma (i.e., sexual abuse, physical abuse, emotional abuse, physical neglect, emotional neglect). Each item is rated on a Likert scale from 1 (Never true) to 5 (Very often true). All subscales (i.e., the five forms of childhood trauma) have a possible score range of 5 to 25. | Phase 2 (outpatient): administered at baseline only | 
| Change in Score on the PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item self-report measure, which assesses the severity of PTSD symptoms according to the diagnostic criteria outlined in the DSM-5. The symptom domains include intrusions (items 1 through 5; scores summed for a total between 0 and 20), avoidance (items 6 through 7; scores summed for a total between 0 and 8), negative alterations in mood and cognitions (items 8 through 14; scores summed for a total between 0 and 28), and alterations in arousal and reactivity (items 15 through 20; scores summed for a total between 0 and 24). Participants rate the severity of their symptoms in the past month on a Likert scale from 0 (Not at all) to 4 (Extremely). A total PCL-5 score is derived by summing all the values of the items and the total score may range between 0 and 80. A cut-point of 33 is suggested to indicate a probable PTSD diagnosis. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention. This measure will also be administered during week 1, week 3, week 6, and week 9 of the intervention. | 
| Change in score on the PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item self-report measure, which assesses the severity of PTSD symptoms according to the diagnostic criteria outlined in the DSM-5. The symptom domains include intrusions (items 1 through 5; scores summed for a total between 0 and 20), avoidance (items 6 through 7; scores summed for a total between 0 and 8), negative alterations in mood and cognitions (items 8 through 14; scores summed for a total between 0 and 28), and alterations in arousal and reactivity (items 15 through 20; scores summed for a total between 0 and 24). Participants rate the severity of their symptoms in the past month on a Likert scale from 0 (Not at all) to 4 (Extremely). A total PCL-5 score is derived by summing all the values of the items and the total score may range between 0 and 80. A cut-point of 33 is suggested to indicate a probable PTSD diagnosis. | Phase 1 (inpatient): Administered at 3 months post-intervention. This measure will also be administered during week 1, week 3, week 6, and week 9 of the intervention. | 
| Change in Score on the Multiscale Dissociation Inventory (MDI) | The MDI is a 30-item self-report measure, which assesses six domains of dissociative symptoms over the past month, including disengagement (items 1, 7, 13, 19, 25; scores summed for a total between 5 and 25), depersonalization (items 2, 8, 14, 20, 26; scores summed for a total between 5 and 25), derealization (items 3, 9, 15, 21, 27; scores summed for a total between 5 and 25), emotional constriction (items 4, 10, 16, 22, 28; scores summed for a total between 5 and 35), memory disturbance (items 5, 11,17,23,29; scores summed for a total between 5 and 25), and identity dissociation (items 6, 12, 18, 24, 30; scores summed for a total between 5 and 25). Participants rate the severity of their symptoms within the last month on a Likert scale from 1 (Never) to 5 (Very often). A total MDI score is derived by summing all the values of the items and the total score may range between 30 and 150. Higher total scores indicate greater dissociation. | Phase 1 (inpatient): Administered during week 1, week 3, week 6, and week 9 of the intervention and at 3 months post-intervention | 
| Change in Score on the Multiscale Dissociation Inventory (MDI) | The MDI is a 30-item self-report measure, which assesses six domains of dissociative symptoms over the past month, including disengagement (items 1, 7, 13, 19, 25; scores summed for a total between 5 and 25), depersonalization (items 2, 8, 14, 20, 26; scores summed for a total between 5 and 25), derealization (items 3, 9, 15, 21, 27; scores summed for a total between 5 and 25), emotional constriction (items 4, 10, 16, 22, 28; scores summed for a total between 5 and 35), memory disturbance (items 5, 11,17,23,29; scores summed for a total between 5 and 25), and identity dissociation (items 6, 12, 18, 24, 30; scores summed for a total between 5 and 25). Participants rate the severity of their symptoms within the last month on a Likert scale from 1 (Never) to 5 (Very often). A total MDI score is derived by summing all the values of the items and the total score may range between 30 and 150. Higher total scores indicate greater dissociation. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention. This measure will also be administered during week 1, week 3, week 6, and week 9 of the intervention. | 
| Change in Score on the Difficulties in Emotion Regulation Scale (DERS) | The DERS is a 36-item self-report measure, which assesses difficulties with emotion regulation across six domains including nonacceptance of emotional responses (items 11, 12, 21, 23, 25, 29; scores summed for a total between 6 and 30), difficulty engaging in goal-directed behavior (items 13, 18, 20, 26, 33; scores summed for a total between 5 and 25), impulse control difficulties (items 3, 14, 19, 24, 27, 32; scores summed for a total between 6 and 30), lack of emotional awareness (items 2, 6, 8, 10, 17, 34; scores summed for a total between 6 and 30), limited access to emotion regulation strategies (items 15, 16, 22, 28, 30, 31, 35, 36; scores summed for a total between 8 and 40), and lack of emotional clarity (items 1, 4, 5, 7, 9; scores summed for a total between 5 and 25). A total DERS score is derived by summing all the values of the items and this score may range between 36 and 180. Higher scores indicate greater dysfunction with emotion regulation. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention. This measure will also be administered during week 1, week 3, week 6, and week 9 of the intervention. | 
| Change in Score on the Toronto Alexithymia Scale (TAS) | The TAS is a 20-item self-report measure, which assesses difficulties recognizing and naming emotions across three domains including, difficulty identifying feelings (items 1, 3, 6, 7,9, 13, 14; scores summed for a total between 7 and 35), difficulty describing feelings(items 2, 4, 11, 12, 17; scores summed for a total between 5 and 25), and externally oriented thinking (items 5, 8, 10, 15, 16, 18, 19, 20; scores summed for a total between 8 and 40). A total TAS score is derived by summing all the values of the items and the total score may range between 20 and 100. Individuals with scores less than or equal to 51 are interpreted as having no alexithymia. Further, individuals with scores between 52 and 60 are interpreted as having possible alexithymia. Finally, individuals with scores greater than or equal to 61 are interpreted as having alexithymia. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention. | 
| Moral Injury Events Scale (MIES) | The MIES is a 9-item self-report measure assessing moral injury along two dimensions in military and veteran populations - perceived transgressions and perceived betrayals. Each item is rated on a Likert scale from 1 (Strongly - Page 9 of 12 disagree) to 6 (Strongly agree). The Perceived Transgressions subscale consists of the items 1 through 6 (scores summed for a total between 6 and 36), while the Perceived Betrayals subscale consists of the items 7 through 9 (scores summed for a total between 3 and 18). The total MIES score is the sum of all 9 items, with a total score ranging between 9 and 54. Higher values on the subscales and total score indicate greater moral injury. | Phase 2 (outpatient): baseline, post- intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention. | 
| Change in accuracy of episodic memory recall as measured using a standard EEG | The standard EEG is performed using a 16 channel dry electrode wireless EEG headset designed to study the dynamics of large-scale brain networks known to impact mood, cognition, and behavior. Participants will be presenting with a total of 10 alternating blocks of autobiographical memory and working memory trials. They will be asked to describe 10 positive or neutral specific event memories in vivid detail. Additionally, they will be asked to identify 10-15 words/ phrases that would uniquely elicit these memories. They will then imagine themselves in 10 future imagined events, with 10-15 words/phrases that would uniquely elicit these imagined memories. | Phase 1 (inpatient): baseline, post-intervention at 3 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial education, cognitive remediation, public safety personnel, first responders, military