Goal Management Training in Individuals With PTSD

Study Overview
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Brief Summary
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This study will evaluate the effect of a manualized treatment (Goal Management Training, or GMT) on the cognitive impairments associated with PTSD (Post-Traumatic Stress Disorder), as well as any impact on PTSD symptems themselves. Participants will be randomized to either GMT group treatment, or a wait list condition.

Detailed Description
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PTSD has an emotional impact on individuals, but it is also associated with impaired cognitive functioning (e.g., processing speed, attention, executive functioning). This study is an effectiveness trial investigating a cognitive remediation intervention (Goal Management Training, or GMT) that has been shown to improve the cognitive impairment observed in other populations (e.g., older adults). The present study will investigate the impact of GMT in adults experiencing PTSD (including frontline healthcare workers suffering from PTSD related to the COVID-19 pandemic) and its associated cognitive impairment. Participants will be randomly assigned to one of two treatment conditions - GMT, or a wait list condition (in which GMT will be postponed for approximately 21 weeks). Due to the pandemic, this study will be conducted primarily online (i.e., online assessments and treatment, with optional fMRI scans - functional magnetic resonance imaging). Once all assessments are complete, participants in the wait list condition will be able to begin GMT thelmselves.

Official Title
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An EffectivenessTrial Examining a Novel Approach to Cognitive Remediation in Individuals With Post-Traumatic Stress Disorder (PTSD)

Conditions
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PTSD, Post-traumatic Stress Disorder, Cognitive Impairment, Cognitive Dysfunction, Cognitive Deficit

Intervention / Treatment
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* Behavioral: Goal Management Training (GMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of PTSD as determined by our baseline assessment Due to online nature: must have access to (and ability to use) a computer/tablet with a working microphone and camera (or webcam), reliable access to a secure internet connection, and access to a quiet, private space for the assessments and group sessions. Ability to provide informed consent Fluency in written and spoken English must be resident of Ontario (due to restrictions of professional licenses) Exclusion Criteria for those opting in to fMRI scan: any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy) Exclusion Criteria for study in general: history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score < 15 at the time of incident as assessed retrospectively by participant) significant untreated medical illness history of neurological or neurodevelopmental disorder history of any pervasive developmental disorder any medical disorder known to adversely affect cognition within the last 12 months lifetime bipolar or psychotic disorder alcohol/substance abuse or dependence within the last 3 months extensive narcotic use (e.g., fentanyl, oxycodone, etc.), use of anti-cholinergics, anti-psychotics, psychostimulants, or benzodiazepines ECT (electroconvulsive therapy) within the last 12 months significant dissociative disorder (as determined by our baseline assessment) suicide attempt in last 6 months pregnancy (due to impact of hormones on cognitive abilities) hearing or vision issues that would interfere with effective online participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This study is an effectiveness trial investigating GMT as an intervention for both PTSD-related cognitive impairment/dysfunction, and PTSD symptoms themselves. Participants will be randomized to one of two conditions: GMT or wait list.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal Management Training (GMT)<br>Participants in this arm will attend 9 weekly, 2-hour group GMT appointments. | Behavioral: Goal Management Training (GMT)<br>* GMT is a structured, short-term cognitive remediation program with an emphasis on mindfulness and practice in planning and completion of goal-oriented behaviours. The main objective of GMT is to help participants regain executive control in order to better define goals and monitor performance in achieving them. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments. Mindfulness meditation is also incorporated for the purpose of developing the skill of bringing one's mind to the present to monitor ongoing behaviour, goal states, and the relationship between them, and for the development of attentional control. The program incorporates real-life examples to illustrate goal attainment failures and successes, as well as in-session practice of complex tasks that mimic real-life tasks - typically a challenge for individuals with executive function deficits (e.g., planning and set-shifting tasks).<br>|
| No Intervention: Wait List<br>Participants in this arm will receive no treatment for approximately 21 weeks (at which point, they will be offered the same, standard GMT treatment). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment | A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance. | 9 weeks | 
| Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment | A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance. | 12 weeks | 
| Change in score on Tower Test (part of Millisecond's online cognitive battery) from baseline to post-treatment assessment. | Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test. | 9 weeks | 
| Change in score on Tower Test (part of Millisecond's online cognitive battery) from post-treatment to 3-month follow-up assessment. | Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test. | 12 weeks | 
| Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment | A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation. | 9 weeks | 
| Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment | A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation. | 12 weeks | 
| Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment | Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms | 9 weeks | 
| Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment | Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GMT, Goal Management Training, mindfulness, Cognitive Remediation