Cognitive Training for Functioning in PTSD
Cognitive Training to Address Functioning and Symptoms in Veterans With Posttraumatic Stress Disorder
研究概览
详细说明
Posttraumatic stress disorder (PTSD) is a prevalent and debilitating condition among Veterans, associated with high healthcare utilization, physical comorbidities, and increased suicide risk. Despite the effectiveness of first-line psychotherapies for PTSD, these treatments do not universally address the neuropsychological deficits often seen in PTSD, such as impaired executive functioning, which contributes to both poor functional recovery and exacerbation of symptoms. There is a critical need for novel interventions targeting executive functioning to complement existing therapies and improve outcomes. The investigator team has developed Cognitive ENhancement Training (COGENT), a low-burden, computer-based neurotherapeutic program designed to improve executive functioning. Preliminary data suggest COGENT may improve cognitive and affective symptoms in Veterans with PTSD, but larger, rigorous trials are needed to assess its clinical utility.
COGENT represents a promising innovation in PTSD treatment by focusing on enhancing executive functioning, which is directly implicated in the regulation of PTSD symptoms. Unlike existing therapies, COGENT targets cognitive deficits that drive symptom severity using a relatively brief, computer-administered format, offering a potential alternative pathway for improving recovery. If successful, this intervention could provide a scalable, cost-effective, and easily integrated treatment for Veterans with PTSD, improving their daily functioning and reducing symptom burden.
Specific Aims: 1) Evaluate the impact of COGENT on clinical functioning and PTSD symptoms. Investigators hypothesize that COGENT will lead to significant reductions in cognitive disability and re-experiencing symptoms relative to a control group. 2) Assess the real-world effects of COGENT on cognitive, emotional, and functional outcomes using smartphone-based ecological momentary assessments. Investigators hypothesize that COGENT will improve cognitive performance, reduce mood symptoms, and decrease functional impairment in everyday settings. Exploratory Aim) Identify predictors of treatment outcomes. This will explore how baseline cognitive performance and sociodemographic and clinical characteristics (e.g., traumatic brain injury history) influence the response to COGENT.
Successful outcomes from this will support the translation of COGENT into VA care. If effective, COGENT could be either provided as direct-to-Veteran services or integrated into routine clinical practice within the existing PTSD treatment programs as a cost-effective, widely accessible option for improving cognitive and clinical outcomes. Further research will explore potential for widespread dissemination and individual-level tailoring to optimize treatment benefits for Veterans with PTSD.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jessica A Bomyea, PhD
- 电话号码：(858) 642-3720
- 邮箱：jessica.bomyea@va.gov
学习地点
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California
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San Diego、California、美国、92161-0002
- VA San Diego Healthcare System, San Diego, CA
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接触：
- Jessica A Bomyea, PhD
- 电话号码：(858) 642-3720
- 邮箱：jessica.bomyea@va.gov
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首席研究员：
- Jessica A Bomyea, PhD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- diagnosis of PTSD
- presence of subjective cognitive complaints
- fluent in English
- willing to attend assessment and treatment sessions
Exclusion Criteria:
- past year history of psychotic or bipolar I disorders
- past year history of severe alcohol or substance use disorder
- history of severe traumatic brain injury or other known neurological condition that may be associated with cognitive dysfunction
- acute suicidality necessitating immediate clinical intervention (within past 3 months)
- presence of circumstances that require imminent intervention prior to other treatment (e.g., current domestic abuse)
- plans for medication changes within the study timeframe
- current or planned evidence-based psychotherapy for PTSD within the study timeframe
- plans for changes to other psychosocial therapy within the study timeframe
- presence of life-threatening or unstable medical conditions
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Cognitive ENhancement Training (COGENT)
Participants will be Veterans assigned to the active cognitive training program, Cognitive ENhancement Training (COGENT).
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COGENT is a computer-administered cognitive training program and consists of a modified working memory capacity task.
COGENT was designed to contain high interference across trials, and requires participants to consistently, actively manage control over working memory interference.
By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems used to manage how information enters and subsequently is removed from working memory, leading to improved performance over time.
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假比较器：Sham Training (ST)
Participants will be Veterans assigned to the sham training comparator (ST), a non-training cognitive program matched for time and memory demands.
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The sham training (ST) requires participants to remember the same total number of items as in COGENT; however, this training contains relatively less proactive interference across trials and is designed to be an "inert" version of the experimental program.
The sham training condition will allow us to evaluate differences based on the proposed working memory interference training element, rather than general elements of the task (e.g., regular staff contact, contact time, general computer interface time).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognitive domain
大体时间：baseline, post (week 10), 3-month follow-up, 6-month follow-up
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The WHODAS is a widely used, standardized tool designed to assess the level of disability experienced by individuals across various health conditions, including mental health disorders like PTSD.
The WHODAS measures disability across six domains of functioning.
The current project will utilize the cognition domain score to measure cognitive disability.
A simple score for the WHODAS 2.0 ranges from 36-180 with higher scores indicating the degree of functional limitations.
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baseline, post (week 10), 3-month follow-up, 6-month follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change in Clinician Administered PTSD Scale-5 (CAPS-5) - reexperiencing scale
大体时间：baseline, post (week 10), 3-month follow-up, 6-month follow-up
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The CAPS-5 semi-structured interview is designed to measure posttraumatic stress disorder diagnostic status as well as symptom severity.
Total scores range from 0 to 20 with higher scores indicating greater severity; change over time will be evaluated.
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baseline, post (week 10), 3-month follow-up, 6-month follow-up
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Baseline neuropsychological performance
大体时间：baseline, post (week 10)
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A brief neuropsychological test battery will be used to predict response to the study intervention, based on evidence from previous work demonstrating that individuals with lower initial cognitive functioning may experience greater improvement in symptoms.
The neuropsychological battery will consist of the Delis-Kaplan Executive Functioning System (DKEFS) Verbal Fluency, TestMyBrain (TMB) Trails, TMB Digit Symbol Matching and Choice Reaction Time, Wechsler Adult Intelligence Scale-IV (WAIS-IV) (Digit Span, Letter Number Sequencing), AX Continuous Performance Test from the Cognitive Neuroscience Test Reliability and Clinical applications for Schizophrenia (CNTRaCS) battery, and the California Verbal Learning Test-II (CVLT-II).
The Montreal Cognitive Assessment (MoCA) screening will also be administered.
All measures will be scored using published norms and a composite z-score by domain will be calculated, with higher scores indicating greater cognitive performance.
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baseline, post (week 10)
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Anxiety symptoms
大体时间：baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Change from baseline in anxiety symptoms as measured by General Anxiety Disorder 7 (GAD-7), as part of measuring broad clinical effects.
The total score ranges from 0-21, with higher scores indicating higher levels of anxiety symptoms.
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baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Depression symptoms
大体时间：baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Change from baseline in depression symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9), as part of measuring broad clinical effects.
The total score ranges from 0-27, with higher scores indicating higher levels of depressive symptoms.
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baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Suicide risk level
大体时间：baseline, post (week 10), 3-month follow-up, 6-month follow-up
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The Columbia Suicide Severity Risk Scale (CSSRS) will be used to measure suicide risk level at all time points, as part of measuring broad clinical effects.
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baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Impulsivity
大体时间：baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Change in impulsivity as measured by the Barratt Impulsiveness Scale (BIS), as part of measuring broad clinical effects.
The total score ranges from 30-120, with higher scores indicating higher levels of impulsivity.
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baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Global functioning (WHODAS 2.0)
大体时间：baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Change in global functional impairment related to social and life responsibilities will be measured by the WHODAS 2.0 (mobility, self-care, getting along, life activities, participation subscales) as part of measuring broad functional effects.
A simple score for the WHODAS 2.0 ranges from 36-180 with higher scores indicating the degree of functional limitations.
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baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Global functioning (IPF)
大体时间：baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Change in global functioning will be measured by the Inventory of Psychosocial Functioning (IPF), as part of measuring broad functional effects.
The IPF measures PTSD-related impairment in social and life responsibilities, such as romantic and family relationships, work, friendships and socializing, parenting, education, and self-care.
Items are scored on a 0 (never) to 6 (always) scale, with higher scores indicating greater functional impairment.
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baseline, post (week 10), 3-month follow-up, 6-month follow-up
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Day-to-day functioning
大体时间：baseline, post (week 10)
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A composite score, Positive Activities for Cognitive Engagement (PACE), will be used to measure COGENT effects on day-to-day functioning.
This composite score will be generated from results of ecological momentary assessment (EMA) surveys and ecological momentary cognitive testing (EMCT), which will be administered to participants via smartphone 3 times per day for the 7-day period directly after the baseline and post-treatment visits.
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baseline, post (week 10)
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合作者和调查者
调查人员
- 首席研究员：Jessica A Bomyea, PhD、VA San Diego Healthcare System, San Diego, CA
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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