Clinical trial NCT04251624: Investigating the Use of Goal Management Therapy in Improving Cognitive Functioning in Public Safety Personnel With PTSD
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Cognitive Deficit
Keywords: cognitive remediation
public safety personnel
psychosocial education
first responders
military
Lead sponsor: Homewood Research Institute
Sponsor class: OTHER
Collaborators: name: McMaster University
name: St. Joseph's Healthcare Hamilton
name: Canadian Institutes of Health Research (CIHR)
name: Homewood Health Centre
First posted: 2020-02-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Score on the Delis-Kaplan Executive Function System (D-KEFS) Tower Test
timeFrame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks
measure: Change in Score on the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding subtest
timeFrame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks
measure: Change in Score on Conners Continuous Performance Task Third Edition (CPT-3)
timeFrame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks
measure: Change in Score on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Phase 1 (inpatient): Baseline, post-intervention at 3 weeks, and post-intervention at 3 months
measure: Change from Baseline in Score on the Cognitive Failures Questionnaire (CFQ) at 3 weeks post-intervention and 3 months post-intervention
timeFrame: 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.
measure: Change in Score on the Return to Work Obstacles and Self-Efficacy Scale - Common Mental Disorders (ROSES-CMD)
timeFrame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks
measure: Change from Baseline in Score on the VOT Hooper Visual Organization Test at 3 weeks post-intervention
timeFrame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks
measure: Change in Score on the Rey-Osterrieth Complex Figure Test (RCFT)
timeFrame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks
measure: Change in Score on the Depression Anxiety Stress Scale (DASS-21)
timeFrame: Phase 1 (Inpatient): Week 1, Week 3, and Week 6 of intervention, and post-intervention at 3 weeks
measure: Change in Score on the Stroop Colour and Word Test (SCWT)
timeFrame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks
measure: Advanced Clinical Solutions Test of Premorbid Functioning (TOPF)
timeFrame: Phase 1 (inpatient): Baseline only
measure: Change from baseline in scores on the PTSD Checklist for DSM-5 (PCL-5) at post-intervention
timeFrame: 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
measure: Change from baseline in scores on the Depression and Anxiety Stress Scale (DASS-21) at post-intervention
timeFrame: 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
measure: Change from baseline in scores on the Sustained Attention Response Task (SART)
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on the Cognitive Failures Questionnaire (CFQ) at post-intervention
timeFrame: 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
measure: Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Functional neurological change from baseline at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Functional neurological change from baseline at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in score on the Sustained Attention Response Task (SART) adapted for functional Magnetic Resonance Imaging (fMRI) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
Secondary outcomes:
measure: Demographic Information
timeFrame: Phase 1 (inpatient): administered at baseline only
measure: Mini International Neuropsychiatric Interview 7.0 (M.I.N.I.)
timeFrame: Phase 1 (inpatient): administered at baseline only
measure: Change in score on the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 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.
measure: Change in Score on the Multiscale Dissociation Inventory (MDI)
timeFrame: Phase 1 (inpatient): administered during week 1, week 3, week 6, and week 9 of the intervention and at 3 months post-intervention
measure: Change in accuracy of episodic memory recall as measured using a standard EEG
timeFrame: Phase 1 (inpatient): baseline, post-intervention at 3 weeks.
measure: Demographic Information
timeFrame: Phase 2 (outpatient): collected at baseline only
measure: Change from baseline in scores on the Multiscale Dissociation Inventory (MDI) at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on the Difficulties in Emotion Regulation Scale (DERS) at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on the Toronto Alexithymia Scale (TAS) at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on selected subtests of the CBS Research battery at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on Digit Symbol Substitution Task at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on selected subtests of the CBS Research battery at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on the Hopkins Verbal Learning Test-Revised (HVLT-R) at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on selected subtests of the CBS Research battery at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on selected subtests of the CBS Research battery at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on the Rey Complex Figure Task (RCFT) at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on selected subtests of the CBS Research battery at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on the Return to work Obstacles and Coping Efficacy - Common Mental Disorders (ROSES-CMD) at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on the World Health Organization's Disability Assessment Schedule (WHODAS 2.0) at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on the Lam Employment Absence and Productivity Scale (LEAPS) at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on the Sheehan Disability Scale (SDS) at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Change from baseline in scores on the BADS Dysexecutive Questionnaire (DEX) at post-intervention
timeFrame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention
measure: Scores on the Life Events Checklist for DSM-5 (LEC-5) at baseline
timeFrame: Phase 2 (outpatient): Administered at baseline only
measure: Scores on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at baseline
timeFrame: Phase 2 (outpatient): Administered at baseline only
measure: Scores on the Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0 at baseline
timeFrame: Phase 2 (outpatient): Administered at baseline only
measure: Scores on the Moral Injury Events Scale (MIES) at baseline
timeFrame: Phase 2 (outpatient): Administered at baseline only
measure: Scores on the Childhood Trauma Questionnaire (CTQ) at baseline
timeFrame: Phase 2 (outpatient): Administered at baseline only
measure: Scores on the Advanced Clinical Solutions (ACS) Test of Premorbid Functioning (TOPF) at baseline
timeFrame: Phase 2 (outpatient): Administered at baseline only
measure: Demographic Information
timeFrame: Phase 3 (fMRI): Collected at baseline only
measure: Change from baseline in scores on the Coding subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on the Symbol Search subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on selected subtests of the Creyos battery at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on the Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on California Verbal Learning Test (CVLT-3) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on selected subtests of the Creyos battery at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on selected subtests of the Creyos battery at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on selected subtests of the Creyos battery at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on selected subtests of the Creyos battery at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in score on the Depression and Anxiety Stress Scale (DASS-21) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline, week 3 of intervention, week 6 of intervention, and post-intervention at 9 weeks
measure: Change from baseline in score on the PTSD Checklist for DSM-5 (PCL-5) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline, week 3 of intervention, week 6 of intervention, and post-intervention at 9 weeks
measure: Change from baseline in score on the Multiscale Dissociation Inventory (MDI) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline, week 3 of intervention, week 6 of intervention, and post-intervention at 9 weeks
measure: Change from baseline in score on the Difficulties in Emotion Regulation Scale (DERS) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline, week 3 of intervention, week 6 of intervention, and post-intervention at 9 weeks
measure: Change from baseline in score on the Toronto Alexithymia Scale (TAS) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in score on the Moral Injury Assessment for Public Safety Personnel (MIA-PSP) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on the BADS Dysexecutive Questionnaire (DEX) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on the Cognitive Failures Questionnaire (CFQ) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline, week 3 of intervention, week 6 of intervention, and post-intervention at 9 weeks
measure: Change from baseline in scores on the Return to work Obstacles and Coping Efficacy - Common Mental Disorders (ROSES-CMD) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on the World Health Organization's Disability Assessment Schedule (WHODAS 2.0) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on the Lam Employment Absence and Productivity Scale (LEAPS) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on the Sheehan Disability Scale (SDS) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Change from baseline in scores on the Survey of Perceived Organizational Support (SPOS) at post-intervention
timeFrame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks
measure: Scores on the Advanced Clinical Solutions (ACS) Test of Premorbid Functioning (TOPF) at baseline
timeFrame: Phase 3 (fMRI): Administered at baseline only
measure: Scores on the Life Events Checklist for DSM-5 (LEC-5) at baseline
timeFrame: Phase 3 (fMRI): Administered at baseline only
measure: Scores on the Mini International Neuropsychiatric Interview 7.0.2 (M.I.N.I.) at baseline
timeFrame: Phase 3 (fMRI): Administered at baseline only
measure: Scores on the Childhood Trauma Questionnaire (CTQ) at baseline
timeFrame: Phase 3 (fMRI): Administered at baseline only
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Homewood Research Institute
state: Ontario
Study officials:
affiliation: McMaster University, St. Joseph's Healthcare Hamilton, Homewood Research Institute
name: Margaret McKinnon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.