跳至主要内容
临床试验/NCT07693686
NCT07693686尚未招募不适用

Cognitive Training to Address Functioning and Symptoms in Veterans With Posttraumatic Stress Disorder

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2027年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
176
试验地点
1
主要终点
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognitive domain

研究概览

简要总结

The proposed study will test a novel, computerized treatment for posttraumatic stress disorder (PTSD) to determine if it helps Veterans functionally recover as measured by reduced cognitive disability and PTSD symptoms. To do so, investigators will evaluate the effects of a cognitive training program that is designed to improve people's ability to manage information in working memory. Investigators will measure self-reported symptoms and disability alongside day-to-day cognition and functioning. The project support the VA Office of Research and Development's mission to improve Veteran participation in their lives and community by determining if this new approach can improve recovery from trauma and exploring for whom the intervention works.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of PTSD
  • presence of subjective cognitive complaints
  • fluent in English
  • willing to attend assessment and treatment sessions

排除标准

  • 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

研究组 & 干预措施

Sham Training (ST)

Sham Comparator

Participants will be Veterans assigned to the sham training comparator (ST), a non-training cognitive program matched for time and memory demands.

干预措施: ST (Sham Training) (Behavioral)

Cognitive ENhancement Training (COGENT)

Experimental

Participants will be Veterans assigned to the active cognitive training program, Cognitive ENhancement Training (COGENT).

干预措施: COGENT (Cognitive ENhancement Training) (Behavioral)

结局指标

主要结局

Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognitive domain

时间窗: baseline, post (week 10), 3-month follow-up, 6-month follow-up

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.

次要结局

  • Change in Clinician Administered PTSD Scale-5 (CAPS-5) - reexperiencing scale(baseline, post (week 10), 3-month follow-up, 6-month follow-up)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Cognitive Training for Functioning in PTSD | 临床试验