An EffectivenessTrial Examining a Novel Approach to Cognitive Remediation in Individuals With Post-Traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in score on Tower Test (part of Millisecond's online cognitive battery) from post-treatment to 3-month follow-up assessment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Change in score on Tower Test (part of Millisecond's online cognitive battery) from post-treatment to 3-month follow-up assessment.
时间窗: 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.
Change in score on Tower Test (part of Millisecond's online cognitive battery) from baseline to post-treatment assessment.
时间窗: 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.
Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment
时间窗: 12 weeks
Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms
Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment
时间窗: 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.
Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment
时间窗: 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.
Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment
时间窗: 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.
Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment
时间窗: 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.
Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment
时间窗: 9 weeks
Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms
次要结局
未报告次要终点