Goal Management Training in Individuals With PTSD

Lawson Health Research Institute

Status: Withdrawn

Conditions: Post-traumatic Stress Disorder; Cognitive Impairment; PTSD; Cognitive Dysfunction; Cognitive Deficit

Treatments: Behavioral: Goal Management Training (GMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04457271

116096 (Registry Identifier)

10037 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Goal Management Training (GMT)

Experimental group

Description:

Participants in this arm will attend 9 weekly, 2-hour group GMT appointments.

Treatment:

Behavioral: Goal Management Training (GMT)

Wait List

No Intervention group

Description:

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