Clinical trial NCT04457271: Goal Management Training in Individuals With PTSD
Official title: An EffectivenessTrial Examining a Novel Approach to Cognitive Remediation in Individuals With Post-Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Post-traumatic Stress Disorder
Cognitive Impairment
Cognitive Dysfunction
Cognitive Deficit
Keywords: GMT
Goal Management Training
mindfulness
Cognitive Remediation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: FDC Foundation
First posted: 2020-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment
timeFrame: 9 weeks
measure: Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment
timeFrame: 12 weeks
measure: Change in score on Tower Test (part of Millisecond's online cognitive battery) from baseline to post-treatment assessment.
timeFrame: 9 weeks
measure: Change in score on Tower Test (part of Millisecond's online cognitive battery) from post-treatment to 3-month follow-up assessment.
timeFrame: 12 weeks
measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment
timeFrame: 9 weeks
measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment
timeFrame: 12 weeks
measure: Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment
timeFrame: 9 weeks
measure: Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
Study officials:
affiliation: Lawson Research Institute
name: Ruth A. Lanius, MD, 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: 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.
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.