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Post Traumatic Stress DisorderNCT04251624

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

A study testing Goal Management Therapy and Psychosocial Education in people with Post Traumatic Stress Disorder and Cognitive Deficit, run by Homewood Research Institute at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Goal Management Therapy and Psychosocial Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteCanada
Study dates
1 Nov 2019to Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • have a diagnosis of post-traumatic stress disorder on the Clinician Administered PTSD Scale (CAPS)
  • are able to provide written informed consent

Who cannot join

  • 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
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  • a history of neurological disorder
  • a diagnosis of psychotic disorder or bipolar disorder
  • a history of a neurodevelopmental disorder

Trial locations and contacts

1 site in 1 country.

Heather Millman, MA contact

519-824-1010 ext. 32180

HMillman@Homewoodhealth.com

Canada1 site, 1 recruiting

  • Homewood Research Institute

    Guelph, Ontario, N1E6K9

    Heather Millman, MA, 519-824-1010 ext. 32180, HMillman@Homewoodhealth.com

    Recruiting

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

Goal Management Therapy is a structured, short-term, CBT-based, cognitive remediation program with an emphasis on mindfulness, and practice in planning and completion of goal-oriented behaviours. The primary objective of GMT is to train participants to interrupt ongoing, disruptive behaviour 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 real-life deficits, and homework/practice activities.

The matched psychosocial education control group will focus on educating participants on topics like brain function and neuroplasticity, and on practicing lifestyle interventions (e.g., sleep hygiene, stress management, exercise).

The study will take place in three 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 personnel who are members of the local community.

Phase 3 will consist of 9 sessions of Goal Management Therapy and 9 sessions of psychosocial education among public safety personnel who are members of the local community. This phase will also use functional Magnetic Resonance Imaging (fMRI) scans to investigate potential changes in the neurobiology of participants' brains.

Being tested
Goal Management Therapy, Psychosocial Education
Keywords
cognitive remediation, public safety personnel, psychosocial education, first responders, military
Medical subject headings
Stress Disorders, Post-Traumatic, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goal Management TherapyBehavioural

    Also called Goal Management Training

    A cognitive training program aimed at improving cognitive deficits such as in memory, attention, learning, and executive functioning.

  • Psychosocial EducationBehavioural

    A group therapy program focusing on brain function, neuroplasticity, and lifestyle interventions.

Study groups in NCT04251624
Study groupRoleWhat they receive
Goal Management TherapyExperimentalGoal 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. Phase 3: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length.
Receives: Behavioral: Goal Management Therapy
Psychosocial EducationActive comparatorPsychosocial education will provide participants with 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. Phase 3: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length.
Receives: Behavioral: Psychosocial Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Score on the 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.

    Measured: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks

  2. Change in Score on the 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.

    Measured: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks

  3. Change in Score on Conners Continuous Performance Task Third Edition (CPT-3)

    A neuropsychological assessment of inattentiveness, impulsivity, sustained attention, and vigilance. Values include:

    1. 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.

    Measured: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks

  4. 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.

    Measured: Phase 1 (inpatient): Baseline, post-intervention at 3 weeks, and post-intervention at 3 months

  5. Change from Baseline in Score on the Cognitive Failures Questionnaire (CFQ) at 3 weeks post-intervention and 3 months post-intervention

    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.

    Measured: Phase 1 (inpatient): Baseline, post-intervention at 3 weeks, and post-intervention at 3 months. This measure will also be administered during week 1, week 3, week 6, and week 9 of the intervention.

  6. 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.

    Measured: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks

  7. Change from Baseline in Score on the VOT Hooper Visual Organization Test at 3 weeks post-intervention

    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.

    Measured: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks

  8. Change in Score on the Rey-Osterrieth Complex Figure Test (RCFT)

    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.

    Measured: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks

  9. 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).

    Measured: Phase 1 (Inpatient): Week 1, Week 3, and Week 6 of intervention, and post-intervention at 3 weeks

  10. Change in Score on the Stroop Colour and Word Test (SCWT)

    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.

    Measured: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks

  11. 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.

    Measured: Phase 1 (inpatient): Baseline only

  12. Change from baseline in scores on the PTSD Checklist for DSM-5 (PCL-5) at post-intervention

    A 20-item self-report measure that assesses the severity of PTSD symptoms according to the diagnostic criteria outlined in the DSM-5. Symptom domains are intrusions, avoidance, negative alterations in mood and cognitions, and alterations in arousal and reactivity.

    Measured: Phase 2 (outpatient): Baseline, week 3 of intervention, week 6 of intervention, post-intervention at 9 weeks, 3 months post-intervention, and 6 months post-intervention

  13. Change from baseline in scores on the Depression and Anxiety Stress Scale (DASS-21) at post-intervention

    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.

    Measured: Phase 2 (outpatient): Baseline, week 3 of intervention, week 6 of intervention, post-intervention at 9 weeks, 3 months post-intervention, and 6 months post-intervention

  14. Change from baseline in scores on the Sustained Attention Response Task (SART)

    Assesses sustained attention by requiring participants to withhold behavioural response to a single, infrequent target presented among a background of frequent non-targets; administered using Inquisit Web by Millisecond (software for administering neuropsychological testing online).

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  15. Change from baseline in scores on the Cognitive Failures Questionnaire (CFQ) at post-intervention

    A 25-item measure of self-reported cognitive impairment 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").

    Measured: Phase 2 (outpatient): Baseline, week 3 of intervention, week 6 of intervention, post-intervention at 9 weeks, 3 months post-intervention, and 6 months post-intervention

  16. Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at post-intervention

    A 30-item structured, clinician-administered interview used to make a lifetime or current diagnosis of PTSD and to assess PTSD symptoms. Questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms on social and occupational functioning, and specifications for the dissociative subtype.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  17. Functional neurological change from baseline at post-intervention

    Functional Magnetic Resonance Imaging (fMRI) scans done at baseline and post-intervention will be compared to determine whether changes are apparent, post-intervention, in the functional organisation of the Central Executive Network (CEN)

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  18. Functional neurological change from baseline at post-intervention

    Functional Magnetic Resonance Imaging (fMRI) scans done at baseline and post-intervention will be compared to determine whether changes are apparent, post-intervention, in myelin amounts in regions associated with cognitive function

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  19. Change from baseline in score on the Sustained Attention Response Task (SART) adapted for functional Magnetic Resonance Imaging (fMRI) at post-intervention

    A computer-based 'Go/No-Go' task adapted for fMRI that requires participants to inhibit a behavioural response to a single, infrequent target appearing amidst a presentation of frequent non-targets.

    Participants will be asked to press a button for every number presented except "3", under two conditions:

    1. a randomized presentation of numbers in two sets, each lasting one minute, and,
    2. a sequential presentation of numbers. Each condition will be presented three times. The second presentation of the numbers will be preceded by certain specific emotion-evoking 'trauma words' identified by the participant at a prior appointment.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

Secondary outcomes (55)

  1. Demographic Information

    Self-report of 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).

    Measured: Phase 1 (inpatient): administered at baseline only

  2. Mini International Neuropsychiatric Interview 7.0 (M.I.N.I.)

    The M.I.N.I. is a structured clinician administered interview to assess psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5).

    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:

    1. Major Depressive Episode ii) Suicidality iii) Manic and Hypomanic Episodes iv) Panic Disorder
    2. Agoraphobia vi) Social Anxiety Disorder vii) Obsessive Compulsive Disorder viii) Alcohol Use Disorder ix) Substance Use Disorder
    3. Psychotic Disorders and Mood Disorder with Psychotic Features xi) Anorexia Nervosa xii) Bulimia Nervosa xiii) Binge Eating Disorder; and xiiii) Generalized Anxiety Disorder.

    Measured: Phase 1 (inpatient): administered at baseline only

  3. Change in score on the PTSD Checklist for DSM-5 (PCL-5)

    The PCL-5 is 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 (DSM-5).

    The symptom domains are:

    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-off point of 33 is suggested to indicate a probable PTSD diagnosis.

    Measured: 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.

  4. Change in Score on the Multiscale Dissociation Inventory (MDI)

    The MDI is a 30-item self-report measure that assesses six domains of dissociative symptoms over the past month:

    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.

    Measured: Phase 1 (inpatient): administered during week 1, week 3, week 6, and week 9 of the intervention and at 3 months post-intervention

  5. 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.

    Measured: Phase 1 (inpatient): baseline, post-intervention at 3 weeks.

  6. Demographic Information

    Age, sex, race, education, marital status, employment status, and employment type (e.g., active military member, veteran, public safety personnel, first responder, or other).

    Measured: Phase 2 (outpatient): collected at baseline only

  7. Change from baseline in scores on the Multiscale Dissociation Inventory (MDI) at post-intervention

    A 30-item self-report measure that assesses six domains of dissociative symptoms over the past month -- disengagement, depersonalization, derealization, emotional constriction, memory disturbance, and identity dissociation.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  8. Change from baseline in scores on the Difficulties in Emotion Regulation Scale (DERS) at post-intervention

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

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  9. Change from baseline in scores on the Toronto Alexithymia Scale (TAS) at post-intervention

    A 20-item self-report measure that assesses difficulties recognizing and naming emotions across three domains -- difficulty identifying feelings, difficulty describing feelings, and externally oriented thinking.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  10. Change from baseline in scores on selected subtests of the CBS Research battery at post-intervention

    The Double Trouble, Feature Match, Spatial Planning, and Odd One Out subtests of the CBS Research Battery will be administered remotely using Cambridge Brain Sciences (CBS; a web-based platform for assessing cognitive functioning), and Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess executive functioning, processing speed, and attention.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  11. Change from baseline in scores on Digit Symbol Substitution Task at post-intervention

    Digit Symbol Substitution Task will be administered remotely using Inquisit Web by Millisecond (software for administering neuropsychological testing online) to assess processing speed and attention.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  12. Change from baseline in scores on selected subtests of the CBS Research battery at post-intervention

    The Paired Associates and Digit Span subtests of the CBS Research Battery will be administered remotely using Cambridge Brain Sciences (CBS; a web-based platform for assessing cognitive functioning) and Zoom for healthcare (a PHIPA-compliant video conferencing platform) to assess declarative memory.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  13. Change from baseline in scores on the Hopkins Verbal Learning Test-Revised (HVLT-R) at post-intervention

    The Hopkins Verbal Learning Test-Revised (HVLT-R) will be administered remotely using Zoom for healthcare (a PHIPA-compliant video conferencing platform) to assess declarative memory.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  14. Change from baseline in scores on selected subtests of the CBS Research battery at post-intervention

    The Grammatical Reasoning subtest of the CBS Research Battery will be administered remotely using Cambridge Brain Sciences (CBS; a web-based platform for assessing cognitive functioning), and Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess the ability to quickly understand and make valid conclusions about concepts expressed in words.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  15. Change from baseline in scores on selected subtests of the CBS Research battery at post-intervention

    The Rotations and Polygons subtests of the CBS Research Battery will be administered remotely using Cambridge Brain Sciences (CBS; a web-based platform for assessing cognitive functioning) Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess visuospatial/visuoconstructive ability and sensorimotor integration.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  16. Change from baseline in scores on the Rey Complex Figure Task (RCFT) at post-intervention

    The Rey Complex Figure Task (RCFT) will be administered remotely using Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess visuospatial/visuoconstructive ability and sensorimotor integration.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  17. Change from baseline in scores on selected subtests of the CBS Research battery at post-intervention

    The Token Search, Monkey Ladder, and Spatial Span subtests of the CBS Research Battery will be administered remotely using Cambridge Brain Sciences (CBS; a web-based platform for assessing cognitive functioning) and Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess visual and visuospatial working memory.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

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

    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.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

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

    A self-report measure that assesses health and disability on six domains of functioning in life: cognition, mobility, self-care, getting along (interacting with others), life activities, and participation (participating in society).

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

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

    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:

    1. 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.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  21. Change from baseline in scores on the Sheehan Disability Scale (SDS) at post-intervention

    A 3-item self-report measure of disability in work, social relationships, and family life. Items are scored on a Likert scale between 0 and 10 and are summed into a single dimensional measure of global functional impairment.

    Total score may range from 0 to 30, with higher scores indicating greater impairment.

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  22. Change from baseline in scores on the BADS Dysexecutive Questionnaire (DEX) at post-intervention

    A 20-item measure of self-reported cognitive impairment 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").

    Measured: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention

  23. Scores on the Life Events Checklist for DSM-5 (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.

    Measured: Phase 2 (outpatient): Administered at baseline only

  24. Scores on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at baseline

    A 30-item structured, clinician-administered interview used to make a lifetime or current diagnosis of PTSD and to assess PTSD symptoms. Questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms on social and occupational functioning, and specifications for the dissociative subtype.

    Measured: Phase 2 (outpatient): Administered at baseline only

  25. Scores on the Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0 at baseline

    A structured clinician-administered interview that assesses psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.

    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.

    Measured: Phase 2 (outpatient): Administered at baseline only

  26. Scores on the Moral Injury Events Scale (MIES) at baseline

    A 9-item self-report measure assessing moral injury along two dimensions in military and veteran populations -- perceived transgressions and perceived betrayals.

    Measured: Phase 2 (outpatient): Administered at baseline only

  27. 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.

    Measured: Phase 2 (outpatient): Administered at baseline only

  28. 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).

    Measured: Phase 2 (outpatient): Administered at baseline only

  29. Demographic Information

    Age, sex, race, education, relationship status, employment status, and profession (whether police, firefighter, volunteer firefighter, search and rescue personnel, paramedic, nurse, correctional officer, probation officer, parole officer, or emergency dispatcher)

    Measured: Phase 3 (fMRI): Collected at baseline only

  30. Change from baseline in scores on the Coding subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) at post-intervention

    The Coding subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) will be administered in-person to assess processing speed and attention.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  31. Change from baseline in scores on the Symbol Search subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) at post-intervention

    The Symbol Search subtests of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) will be administered in-person to assess processing speed and attention.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  32. Change from baseline in scores on selected subtests of the Creyos battery at post-intervention

    The Double Trouble, Feature Match, Spatial Planning, and Odd One Out subtests of the Creyos battery will be administered remotely using Creyos (formerly known as CBS; a web-based platform for assessing cognitive functioning) and Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess executive functioning, processing speed, and attention.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  33. Change from baseline in scores on the Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) at post-intervention

    The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) will be administered in-person to assess declarative memory.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  34. Change from baseline in scores on California Verbal Learning Test (CVLT-3) at post-intervention

    The California Verbal Learning Test (CVLT-3, standard and alternate forms) will be administered over Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess declarative memory.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  35. Change from baseline in scores on selected subtests of the Creyos battery at post-intervention

    The Paired Associates and Digit Span subtests of the Creyos battery will be administered remotely using Creyos (formerly known as CBS; a web-based platform for assessing cognitive functioning) and Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess declarative memory.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  36. Change from baseline in scores on selected subtests of the Creyos battery at post-intervention

    The Grammatical Reasoning subtest of the Creyos Battery will be administered remotely using Creyos (formerly known as CBS; a web-based platform for assessing cognitive functioning) and Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess the ability to quickly understand and make valid conclusions about concepts expressed in words.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  37. Change from baseline in scores on selected subtests of the Creyos battery at post-intervention

    The Rotations and Polygons subtests of the Creyos Battery will be administered remotely using Creyos (formerly known as CBS; a web-based platform for assessing cognitive functioning) and Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess visuospatial/visuoconstructive ability and sensorimotor integration.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  38. Change from baseline in scores on selected subtests of the Creyos battery at post-intervention

    Token Search, Monkey Ladder, and Spatial Span subtests of the CBS Research Battery will be administered remotely using Creyos (formerly known as CBS; a web-based platform for assessing cognitive functioning) and Zoom for Healthcare (a PHIPA-compliant video conferencing platform) to assess visual/visuospatial working memory.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

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

    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.

    Measured: Phase 3 (fMRI): Baseline, week 3 of intervention, week 6 of intervention, and post-intervention at 9 weeks

  40. Change from baseline in score on the PTSD Checklist for DSM-5 (PCL-5) at post-intervention

    A 20-item self-report measure that assesses the severity of PTSD symptoms according to the diagnostic criteria outlined in the DSM-5. Symptom domains are intrusions, avoidance, negative alterations in mood and cognitions, and alterations in arousal and reactivity.

    Measured: Phase 3 (fMRI): Baseline, week 3 of intervention, week 6 of intervention, and post-intervention at 9 weeks

  41. Change from baseline in score on the Multiscale Dissociation Inventory (MDI) at post-intervention

    A 30-item self-report measure that assesses six domains of dissociative symptoms over the past month -- disengagement, depersonalization, derealization, emotional constriction, memory disturbance, and identity dissociation.

    Measured: Phase 3 (fMRI): Baseline, week 3 of intervention, week 6 of intervention, and post-intervention at 9 weeks

  42. Change from baseline in score on the Difficulties in Emotion Regulation Scale (DERS) at post-intervention

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

    Measured: Phase 3 (fMRI): Baseline, week 3 of intervention, week 6 of intervention, and post-intervention at 9 weeks

  43. Change from baseline in score on the Toronto Alexithymia Scale (TAS) at post-intervention

    A 20-item self-report measure that assesses difficulties recognizing and naming emotions across three domains -- difficulty identifying feelings, difficulty describing feelings, and externally oriented thinking.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  44. Change from baseline in score on the Moral Injury Assessment for Public Safety Personnel (MIA-PSP) at post-intervention

    A 17-item self-report measure of work-related morally injurious experiences unique to public safety personnel across three underlying factors -- perpetrations, betrayals, and emotional sequelae.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  45. Change from baseline in scores on the BADS Dysexecutive Questionnaire (DEX) at post-intervention

    A 20-item measure of self-reported cognitive impairment 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").

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  46. Change from baseline in scores on the Cognitive Failures Questionnaire (CFQ) at post-intervention

    A 25-item measure of self-reported cognitive impairment 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").

    Measured: Phase 3 (fMRI): Baseline, week 3 of intervention, week 6 of intervention, and post-intervention at 9 weeks

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

    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.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

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

    A self-report measure that assesses health and disability on six domains of functioning in life: cognition, mobility, self-care, getting along (interacting with others), life activities, and participation (participating in society).

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

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

    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:

    1. 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.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  50. Change from baseline in scores on the Sheehan Disability Scale (SDS) at post-intervention

    A 3-item self-report measure of disability in work, social relationships, and family life. Items are scored on a Likert scale between 0 and 10 and are summed into a single dimensional measure of global functional impairment.

    Total score may range from 0 to 30, with higher scores indicating greater impairment.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  51. Change from baseline in scores on the Survey of Perceived Organizational Support (SPOS) at post-intervention

    Assesses the extent to which an individual believes that their organization is a) committed to them, b) values their continued membership, and c) is generally concerned about their well-being.

    Measured: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks

  52. 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).

    Measured: Phase 3 (fMRI): Administered at baseline only

  53. Scores on the Life Events Checklist for DSM-5 (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.

    Measured: Phase 3 (fMRI): Administered at baseline only

  54. Scores on the Mini International Neuropsychiatric Interview 7.0.2 (M.I.N.I.) at baseline

    A structured clinician-administered interview that assesses psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.

    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.

    Measured: Phase 3 (fMRI): Administered at baseline only

  55. 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.

    Measured: Phase 3 (fMRI): Administered at baseline only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start1 Nov 2019
  3. Primary completionFeb 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants assigned to the experimental group (Goal Management Therapy) will receive either 6 (phase 1) or 9 (phase 2 and phase 3) 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)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04251624
Sponsor's protocol ID
19-05
Status last verified
Jan 2024
First submitted
12 Aug 2019
Last updated
16 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Boyd JE, Lanius RA, McKinnon MC. Mindfulness-based treatments for posttraumatic stress disorder: a review of the treatment literature and neurobiological evidence. J Psychiatry Neurosci. 2018 Jan;43(1):7-25. doi: 10.1503/jpn.170021. Epub 2017 Oct 2.

    PubMed 29252162

  • Boyd JE, Protopopescu A, O'Connor C, Neufeld RWJ, Jetly R, Hood HK, Lanius RA, McKinnon MC. Dissociative symptoms mediate the relation between PTSD symptoms and functional impairment in a sample of military members, veterans, and first responders with PTSD. Eur J Psychotraumatol. 2018 May 17;9(1):1463794. doi: 10.1080/20008198.2018.1463794. eCollection 2018.

    PubMed 29805778

  • McKinnon MC, Boyd JE, Frewen PA, Lanius UF, Jetly R, Richardson JD, Lanius RA. A review of the relation between dissociation, memory, executive functioning and social cognition in military members and civilians with neuropsychiatric conditions. Neuropsychologia. 2016 Sep;90:210-34. doi: 10.1016/j.neuropsychologia.2016.07.017. Epub 2016 Jul 18.

    PubMed 27444881

  • Meusel LA, Hall GB, Fougere P, McKinnon MC, MacQueen GM. Neural correlates of cognitive remediation in patients with mood disorders. Psychiatry Res. 2013 Nov 30;214(2):142-52. doi: 10.1016/j.pscychresns.2013.06.007. Epub 2013 Aug 30.

    PubMed 23993991

  • Lanius RA, Frewen PA, Tursich M, Jetly R, McKinnon MC. Restoring large-scale brain networks in PTSD and related disorders: a proposal for neuroscientifically-informed treatment interventions. Eur J Psychotraumatol. 2015 Mar 31;6:27313. doi: 10.3402/ejpt.v6.27313. eCollection 2015.

    PubMed 25854674

Questions about this trial

What is this clinical trial studying?

A study testing Goal Management Therapy and Psychosocial Education in people with Post Traumatic Stress Disorder and Cognitive Deficit, run by Homewood Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Heather Millman, MA (519-824-1010 ext. 32180, HMillman@Homewoodhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Score on the Delis-Kaplan Executive Function System (D-KEFS) Tower Test (time frame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04251624, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.

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