Cognitive Rehabilitation for Veterans With PNES
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Rehabilitation And Functional Treatment (CRAFT).
- Who it may be relevant to
- Registry conditions: Psychogenic Nonepileptic Seizures (PNES). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cognitive and Functional Telehealth-based Assessment and Intervention in Veterans With Psychogenic Nonepileptic Seizures
Overview
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.
Detailed description
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.
Aim 2: Develop a feasible telehealth-based cognitive rehabilitation workbook for improving daily functioning in Veterans with PNES, informed by feedback from 12 Veterans with PNES and 12 treatment providers.
H2: The cognitive workbook for improving everyday functions will show promise, as measured by mean workbook ratings of 4 on the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) in Veterans with PNES and PNES treatment providers.
Aim 3: Evaluate feasibility of the cognitive treatment with a pilot single arm trial in 20 Veterans with PNES.
H3a: Veterans with PNES will rate the cognitive treatment protocol, including functional outcome measures, as acceptable, appropriate, and feasible, based on mean ratings of 4 on the AIM, IAM, and FIM, respectively.
H3b: Veterans with PNES will show improvement in the co-primary outcomes of cognition and daily functioning, with at least a small to moderate effect size (d 0.30).
Methodology: Veterans with PNES will be recruited from 19 nationwide VA Epilepsy Centers of Excellence sites. Feasibility of recruitment is supported by my VISN1 CDA study. CDA2 Study 1 will analyze qualitative interview data in Veterans with PNES to inform workbook development. Study 2 will develop a cognitive treatment workbook, with the AIM, IAM, and FIM as outcomes. Study 3 will pilot test the intervention, with feasibility (AIM, IAM, and FIM), and composite cognition and daily function (WHODAS 2.0) scores as outcomes.
Path to Translation/Implementation: This CDA2 responds to a golden opportunity to develop, refine, and pilot test a workbook-based cognitive intervention for Veterans with PNES. The cognitive intervention will be well suited for a subsequent fully powered RCT (an anticipated VA Merit Award), which can demonstrate efficacy and effectiveness. Because the cognitive intervention will be designed with implementation in mind from the start, it will be perfectly positioned for immediate dissemination and sustainability within the VA system.
Interventions
- Behavioral Cognitive Rehabilitation And Functional Treatment (CRAFT)
Cognitive rehabilitation tailored to improve cognition and participation in daily activities for Veterans with PNES
Primary outcome measures
- WHODAS 2.0 Total Score [Time frame: Once at baseline (prior to the intervention) and once following the 8-12 week intervention.]
Secondary outcome measures (1)
- Cognitive Composite [Time frame: Once at baseline (prior to the intervention) and once following the 8-12 week intervention.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- acute psychosis (hallucinations or delusions)
- current active suicidality
- a diagnosis of dementia or intellectual disability
- sensory impairment (e.g., deafness) that would preclude participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Providence VA Medical Center, Providence, RI — Providence
Identifiers
NCT: NCT07316543 · RRD9-001-25M · 1IK2RD000605-01A2