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

NCT04251624 | Unknown

• 1 other identifier: 19-05
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Traumatic Stress Disorder; Cognitive Deficit

Keywords

cognitive remediation; public safety personnel; psychosocial education; first responders; military

Outcome Measures

Primary Outcomes (19)

• 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.

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

• 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.

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

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

  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 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, and post-intervention at 3 months

• 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.

  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.

• 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 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.

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

• 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.

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

• 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): Week 1, Week 3, and Week 6 of intervention, and post-intervention at 3 weeks

• 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.

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

• 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): Baseline only

• 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.

  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

• 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.

  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

• 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).

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

• 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").

  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

• 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.

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

• 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)

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

• 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

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

• 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.

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

Secondary Outcomes (55)

• Demographic Information

  Phase 1 (inpatient): administered at baseline only

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

  Phase 1 (inpatient): administered at baseline only

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

  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)

  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 accuracy of episodic memory recall as measured using a standard EEG

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

Study Arms (2)

Goal Management Therapy

EXPERIMENTAL

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. Phase 3: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length.

Behavioral: Goal Management Therapy

Psychosocial Education

ACTIVE COMPARATOR

Psychosocial 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.

Behavioral: Psychosocial Education

Interventions

Goal Management Therapy BEHAVIORAL

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

Also known as: Goal Management Training

Goal Management Therapy

Psychosocial Education BEHAVIORAL

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

Psychosocial Education

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Homewood Research Institute: lead
• McMaster University: collaborator
• St. Joseph's Healthcare Hamilton: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Homewood Health Centre: collaborator

Study Sites (1)

Homewood Research Institute

Guelph, Ontario, N1E6K9, Canada

RECRUITING

Related Publications (5)

• 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.

  PMID: 29252162 BACKGROUND

• 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.

  PMID: 29805778 BACKGROUND

• 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.

  PMID: 27444881 BACKGROUND

• 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.

  PMID: 23993991 BACKGROUND

• 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.

  PMID: 25854674 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Cognition Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neurocognitive Disorders

Study Officials

• Margaret McKinnon, PhD

  McMaster University, St. Joseph's Healthcare Hamilton, Homewood Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Millman, MA

CONTACT

519-824-1010; HMillman@Homewoodhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: February 5, 2020
• Study Start: November 1, 2019
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)