Cognitive Impairment Clinical Trial
Official title:
An EffectivenessTrial Examining a Novel Approach to Cognitive Remediation in Individuals With Post-Traumatic Stress Disorder (PTSD)
Verified date | February 2023 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 1, 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre - University Hospital | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | Canadian Institutes of Health Research (CIHR), FDC Foundation |
Canada,
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. — View 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.v — View 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. Neuropsych — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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