Goal Management Training in Individuals With PTSD

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04457271
• Other study ID #: 10037
• Secondary ID: 116096
• Status: Withdrawn
• Phase: N/A
• Start date: January 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficit
• Cognitive Dysfunction
• Cognitive Impairment
• Post-traumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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).

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - University Hospital	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR), FDC Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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

Outcome

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