A Trial Examining the Effectiveness of a Novel, Trauma-informed Approach to Cognitive Remediation (Goal Management Training) in Individuals With Post-traumatic Stress Disorder (PTSD) and Co-morbid Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('CAPS-5') at post-intervention and follow-up
研究概览
简要总结
Goal Management Training (GMT) is a program designed to help improve cognitive functioning. For this study, researchers have worked closely with the developers of this program to create a modified version called Trauma-Informed Goal Management Training (TI-GMT), that is more sensitive to the needs of individuals experiencing symptoms of posttraumatic stress and posttraumatic stress disorder (PTSD).
The goal of this clinical trial is to find out whether this modified, Trauma-Informed Goal Management Training program is effective for individuals experiencing symptoms associated with Post-Traumatic Stress Disorder.
The main questions it aims to answer are:
- Does Trauma-Informed Goal Management Training result in improved neuropsychological functioning and reductions in the severity of PTSD symptoms from baseline to post?
- Does Trauma-Informed Goal Management Training result in self-reported improvements in cognitive functioning and the overall ability to function (including intent to return to work, and/or intent to stay at work, reductions in disability status, etc.) from baseline to post?
- Does Trauma-Informed Goal Management Training continue to benefit individuals three months after treatment?
Participants will:
- complete three separate assessments before starting the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
- participate in a nine-week group treatment program (one day a week for two hours)
- complete four separate assessments after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, a feedback interview, and completing a set of questionnaires
- complete three separate assessments three months after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, 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
- •Be fluent in English;
- •Must reside in Ontario;
- •Be able to provide written informed consent;
- •Be between the ages of 18 and 65 (in order to help us generalize results);
- •Meet provisional diagnosis of PTSD using a cut-off of >30 on the PCL-5, administered at the time of screening, to be corroborated with the results of the CAPS-5;
- •Be able to attend regular online, 2-hour sessions once/week for 9 weeks, and be willing to complete the pre-, post-treatment, and follow-up assessments;
- •Have access to a computer with a working microphone and camera, and have reliable and consistent internet;
- •Use benzodiazepines daily or almost daily;
- •Use narcotics daily or almost daily;
- •Endorse alcohol/substance use symptoms on the eligibility screener that may interfere with their ability to participate in the study, to be corroborated with the results of the M.I.N.I. (to be determined by Dr. McKinnon's clinical team);
- •Have a history of Moderate to Severe Brain Injury or loss of consciousness with prolonged effects that interfere with daily functioning at school, work or family unit;
- •Have a history of neurological disorder that may interfere with their ability to participate in the study (to be determined by Dr. McKinnon's clinical team);
- •Have a diagnosis of psychotic disorder or bipolar disorder;
- •Have a diagnosis of neurodevelopmental disorder that may interfere with their ability to participate in the study (to be determined by Dr. McKinnon's clinical team);
- •Have other conditions/impairments/considerations that could interfere with completion of study tasks (to be determined by Dr. McKinnon's clinical team)
- •Have previously participated in GMT
- •Be receiving treatment with anti-cholinergics, anti-psychotic medication, or psychostimulants
- •Had ECT within the past year
- •Are currently engaged in a trauma-specific intervention (EMDR, CPT, and PE) that may impact the findings of the current study (to be determined by Dr. McKinnon's clinical team)
- •Is an active serving member of the Canadian Armed Forces
排除标准
- •daily or almost daily use of benzodiazepines
- •daily or almost daily use of narcotics
- •diagnosed with alcohol use disorder OR substance use disorder in the past 12 months
- •meet criteria on the Mini-International Neuropsychiatric Interview (M.I.N.I.) for diagnosis of alcohol use disorder OR substance use disorder
- •history of moderate-to-severe brain injury and/or loss of consciousness with prolonged effects that interfere with daily functioning at school, work, or family unit
- •history of neurological disorder(s) that may impact ability to participate in the study
- •diagnosis of psychotic disorder(s) or bipolar disorder(s)
- •diagnosis of neurodevelopmental disorder(s) that may impact ability to participate in the study
- •other conditions/impairments/considerations that may interfere with completion of study tasks
- •previous participation in Goal Management Training
- •receiving treatment with anti-cholinergic medication, anti-psychotic medication, or psychostimulants
- •had electroconvulsive therapy (ECT) within the past year
- •currently engaged in a trauma-specific intervention that may impact the findings of the current study such as Eye Movement Desensitization and Reprocessing (EMDR), Cognitive Processing Therapy (CPT), Prolonged Exposure (PE), etc.
研究组 & 干预措施
Trauma-Informed GMT (TI-GMT; offered online)
All participants will be assigned to the TI-GMT condition and will be asked to attend nine weekly, 2-hour virtual group sessions of TI-GMT via Zoom for Healthcare, a PHIPA-compliant video conferencing platform. Each group will consist of 1 or 2 facilitators and up to 10 participants.
干预措施: Trauma-Informed Goal Management Training (TI-GMT) (Behavioral)
结局指标
主要结局
Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('CAPS-5') at post-intervention and follow-up
时间窗: Baseline, post-intervention at 9 weeks, and 3-month follow-up
A 30-item structured, clinician-administered interview used to make a lifetime or current diagnosis of PTSD and to assess PTSD symptoms. Questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms on social and occupational functioning, and specifications for the dissociative subtype. Total scores for severity may range between 0 and 80, with higher scores indicating greater symptom severity.
Change from baseline in scores on the Sustained Attention Response Task ('SART') subtest of the Creyos Battery at post-intervention and follow-up
时间窗: Baseline, post-intervention at 9 weeks, and 3-month follow-up
A 'game-ified' Go/No-Go task that assesses sustained attention, this task requires participants to inhibit a behavioural response to a single, infrequent target appearing amidst a presentation of frequent non-targets. This task will be administering remotely, using Zoom for Healthcare (a PHIPA-compliant video conferencing platform) and Creyos (a web-based platform for assessing cognitive functioning). Scores are calculated based on accuracy of responses (errors) and reaction time (reaction time variability and slowing after errors). Higher scores on each indicate more errors, more variability in reaction time, and more slowing after an error, respectively. A percentile rank ranging between 1 and 99 is generated to indicate the individual's performance in comparison to a population of individuals of the same gender and age group.
次要结局
- Scores on the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('LEC-5') at baseline(Administered at baseline only)
- Scores on the Advanced Clinical Solutions ('ACS') Test of Premorbid Functioning ('TOPF') at baseline(Administered at baseline only)
- Change from baseline in scores on selected neuropsychological assessment measures of Declarative memory at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on selected neuropsychological assessment measures of Visuospatial and Visuoconstructive Ability and Sensorimotor integration at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in score on the Difficulties in Emotion Regulation Scale ('DERS') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on the Return to work Obstacles and Coping Efficacy - Common Mental Disorders ('ROSES-CMD') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on the Mini International Neuropsychiatric Interview 7.0.2 ('M.I.N.I.') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on selected neuropsychological assessment measures of Intellectual functioning at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in score on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('PCL-5') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Scores on the Childhood Trauma Questionnaire ('CTQ') at baseline(Administered at baseline only)
- Change from baseline in scores on the California Verbal Learning Test (CVLT-3) at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on selected neuropsychological assessment measures of Visual and Visuospatial Working Memory at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on selected neuropsychological assessment measures of Executive functioning, Processing speed and Attention at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in score on the Depression and Anxiety Stress Scale ('DASS-21') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in score on the twenty-item Toronto Alexithymia Scale ('TAS-20') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in score on the Multiscale Dissociation Inventory ('MDI') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on the World Health Organization's Disability Assessment Schedule ('WHODAS 2.0') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on the Lam Employment Absence and Productivity Scale ('LEAPS') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Change from baseline in scores on the Survey of Perceived Organizational Support ('SPOS') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
- Demographic Information(Collected at baseline only)
- Change from baseline in score on the Moral Injury Outcome Scale ('MIOS-F') at post-intervention and follow-up(Baseline, post-intervention at 9 weeks, and 3-month follow-up)
研究者
Margaret McKinnon
Professor
McMaster University