Cognitive and Functional Telehealth-based Assessment and Intervention in Veterans With Psychogenic Nonepileptic Seizures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- WHODAS 2.0 Total Score
研究概览
简要总结
Psychogenic nonepileptic seizures (PNES) reflect a subtype of functional neurological disorder (FND) that is common and extremely disabling in Veterans. Cognitive problems are highly prevalent in PNES, they reduce quality of life, and they severely limit daily functioning. Currently, there are no available treatments that target cognition to improve daily function in PNES or other FNDs, leaving a major gap in the literature. Cognitive re-habilitation improves daily functioning in Veterans with related neuropsychiatric disorders and has a high chance of success in Veterans with PNES. The proposed study will solicit direct input from Veterans with PNES via qualitative interviews to inform the design of a cognitive treatment workbook. The workbook will then be iteratively refined based on participatory feedback from Veterans with PNES and their treatment providers. The full cognitive intervention protocol will be pilot tested to inform a fully powered RCT. Results will support a line of research that aims to improve cognition and function in Veterans with PNES and related FNDs.
详细描述
Significance to VA: A cognitive intervention for Veterans with psychogenic nonepileptic seizures (PNES) and other functional neurological disorders (FNDs) is desperately needed. FNDs such as PNES are prevalent, underrecognized, and highly disabling in Veterans. Cognitive dysfunction is one of the most common and disabling symptoms in PNES and other FNDs, it contributes to reduced quality of life, and it is not adequately ad-dressed by available treatments. RCTs examining cognitive rehabilitation interventions in related disorders (e.g., TBI) have repeatedly shown that improving cognition leads to improvements in everyday functioning, including work, school, medication management, and driving. Therefore, a similar approach to treating cognitive problems in Veterans with PNES is very likely to improve their everyday functioning. The current CDA2 project will develop and pilot test a cognitive intervention, adapted from prior successful treatments (e.g., in TBI), and tailored to Veterans with PNES. Because of strong overlap between PNES and other FNDs, the intervention from this CDA2 will be ideally suited for adaptation for the >60,000 U.S. Veterans with any subtype of FND.
Innovation and Impact: This is the first study to develop and pilot test an intervention, grounded in a rehabilitation framework and Veteran participant feedback, to improve cognition and daily functioning in Veterans with PNES. Telehealth will be used for all aspects of the current project, facilitating nationwide study recruitment. Telehealth will improve representativeness of the current study sample (enhancing generalizability) and will increase Veteran access to the intervention by reducing barriers to treatment. Strategies from implementation science (e.g., participatory Veteran research) will be infused into the intervention from the start. This will lead to a cognitive intervention that is ideally suited for dissemination and sustainability in VA clinics nationwide.
Specific Aims:
Aim 1: Explore the impact of cognition on daily function via qualitative interviews in 15 Veterans with PNES.
H1: Problems in attention/processing speed will be related to worse daily function in Veterans with PNES.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •U.S. Veteran
- •able to provide informed consent
- •reports cognitive difficulties
- •prior video EEG diagnosis of PNES
- •English speaking
- •able to read at least at 8th grade level
- •access to a private space with a computer (13-inch monitor)
- •internet access
排除标准
- •acute psychosis (hallucinations or delusions)
- •current active suicidality
- •a diagnosis of dementia or intellectual disability
- •sensory impairment (e.g., deafness) that would preclude participation
研究组 & 干预措施
Intervention
Single arm of pilot trial testing the cognitive rehabilitation intervention
干预措施: Cognitive Rehabilitation And Functional Treatment (CRAFT) (Behavioral)
结局指标
主要结局
WHODAS 2.0 Total Score
时间窗: Once at baseline (prior to the intervention) and once following the 8-12 week intervention.
Everyday functioning as measured by the World Health Organization Disability Assessment Schedule 2.0, range = 0-100, higher scores = greater disability.
次要结局
- Cognitive Composite(Once at baseline (prior to the intervention) and once following the 8-12 week intervention.)