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Goal Management Training in Individuals With PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04457271
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : November 20, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
FDC Foundation
Information provided by (Responsible Party):
Ruth Lanius, Lawson Health Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
PTSD Post-traumatic Stress Disorder Cognitive Impairment Cognitive Dysfunction Cognitive Deficit Behavioral: Goal Management Training (GMT) Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An EffectivenessTrial Examining a Novel Approach to Cognitive Remediation in Individuals With Post-Traumatic Stress Disorder (PTSD)
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Goal Management Training (GMT)
Participants in this arm will attend 9 weekly, 2-hour group GMT appointments.
Behavioral: Goal Management Training (GMT)
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).

No Intervention: Wait List
Participants in this arm will receive no treatment for approximately 21 weeks (at which point, they will be offered the same, standard GMT treatment).



Primary Outcome Measures :
  1. Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment [ Time Frame: 9 weeks ]
    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.

  2. Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment [ Time Frame: 12 weeks ]
    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.

  3. Change in score on Tower Test (part of Millisecond's online cognitive battery) from baseline to post-treatment assessment. [ Time Frame: 9 weeks ]
    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.

  4. Change in score on Tower Test (part of Millisecond's online cognitive battery) from post-treatment to 3-month follow-up assessment. [ Time Frame: 12 weeks ]
    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.

  5. Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment [ Time Frame: 9 weeks ]
    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.

  6. Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment [ Time Frame: 12 weeks ]
    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.

  7. Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment [ Time Frame: 9 weeks ]
    Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms

  8. Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment [ Time Frame: 12 weeks ]
    Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457271


Contacts
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Contact: Suzy - Study Coordinator 519-685-8500 ext 35186 Suzy.Southwell@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
FDC Foundation
Investigators
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Principal Investigator: Ruth A. Lanius, MD, PhD Lawson Research Institute
Publications of Results:
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Responsible Party: Ruth Lanius, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04457271    
Other Study ID Numbers: 10037
116096 ( Registry Identifier: Western University's Research Ethics Board )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only coded data will be shared with co-investigators who are registered with the study's ethics board application.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ruth Lanius, Lawson Health Research Institute:
GMT
Goal Management Training
mindfulness
Cognitive Remediation
Additional relevant MeSH terms:
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Cognitive Dysfunction
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Trauma and Stressor Related Disorders