Psychogenic Nonepileptic Seizures (PNES)CRVWPNCT07316543
Cognitive Rehabilitation for Veterans With PNES
A study testing Cognitive Rehabilitation And Functional Treatment (CRAFT) in people with Psychogenic Nonepileptic Seizures (PNES), run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychogenic Nonepileptic Seizures (PNES)
- What is being tested?
- Cognitive Rehabilitation And Functional Treatment (CRAFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 1 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- acute psychosis (hallucinations or delusions)
- current active suicidality
- a diagnosis of dementia or intellectual disability
- sensory impairment (e.g., deafness) that would preclude participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
Kimberly Marcolivio, MEd CCRP, 401-273-7100 ext. 13464, Kimberly.Marcolivio@va.gov
Kate J Barnabe, MHA, (401) 273-7100 ext. 16272, Kate.Barnabe@va.gov
About this study
Official title: Cognitive and Functional Telehealth-based Assessment and Intervention in Veterans With Psychogenic Nonepileptic Seizures
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.
Read the 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.
- Conditions
- Psychogenic Nonepileptic Seizures (PNES)
- Being tested
- Cognitive Rehabilitation And Functional Treatment (CRAFT)
- Keywords
- functional neurological disorder, functional/dissociative seizures, functional cognitive disorder, cognitive rehabilitation
- Medical subject headings
- Psychogenic Nonepileptic Seizures, Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Rehabilitation And Functional Treatment (CRAFT)Behavioural
Cognitive rehabilitation tailored to improve cognition and participation in daily activities for Veterans with PNES
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Single arm of pilot trial testing the cognitive rehabilitation intervention Receives: Behavioral: Cognitive Rehabilitation And Functional Treatment (CRAFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHODAS 2.0 Total Score
Everyday functioning as measured by the World Health Organization Disability Assessment Schedule 2.0, range = 0-100, higher scores = greater disability.
Measured: Once at baseline (prior to the intervention) and once following the 8-12 week intervention.
Secondary outcomes (1)
Cognitive Composite
Composite of scores from standardized neuropsychological tests measuring multiple cognitive domains. Because this measure is a composite of many individual cognitive test scores, it will be represented by a Z-score and does not have a minimum or maximum value.
Measured: Once at baseline (prior to the intervention) and once following the 8-12 week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start2 Mar 2026
- Primary completion1 Jul 2031 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychogenic Nonepileptic Seizures (PNES)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Development of a cognitive rehabilitation intervention to improve cognition and everyday functioning for Veterans with PNES.
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ryan A Van Patten, PhD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316543
- Sponsor's protocol ID
- RRD9-001-25M
- Other IDs
- 1IK2RD000605-01A2
- Acronym
- CRVWP
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: One or more data sets without personal identifiers will be generated during the data analysis phase of this study. The data sets will include all data underlying any publications generated by this study and therefore these will be sufficient to reproduce or verify any published findings. The final data set(s) for this study will be maintained locally at VA Providence until enterprise-level resources become available for long-term storage and access.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Functional Telehealth-based Assessment and Intervention in Veterans With Psychogenic Nonepileptic Seizures
- ClinicalTrials.gov ID
- NCT07316543
- Acronym / sponsor ID
- CRVWP / RRD9-001-25M
- Conditions
- Psychogenic Nonepileptic Seizures (PNES)
- Keywords
- functional neurological disorder, functional/dissociative seizures, functional cognitive disorder, cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 1 Jul 2031 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Development of a cognitive rehabilitation intervention to improve cognition and everyday functioning for Veterans with PNES.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Cognitive Rehabilitation And Functional Treatment (CRAFT)Single arm of pilot trial testing the cognitive rehabilitation intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- U.S. Veteran
- able to provide informed consent
- reports cognitive difficulties
- prior video EEG diagnosis of PNES
- English speaking
Key exclusion criteria (4 listed)
- acute psychosis (hallucinations or delusions)
- current active suicidality
- a diagnosis of dementia or intellectual disability
- sensory impairment (e.g., deafness) that would preclude participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Rehabilitation And Functional Treatment (CRAFT)Cognitive rehabilitation tailored to improve cognition and participation in daily activities for Veterans with PNES | Behavioural | Intervention |
Primary outcome
WHODAS 2.0 Total Score
Time frame: 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.
1 secondary outcome
Cognitive Composite
Time frame: Once at baseline (prior to the intervention) and once following the 8-12 week intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Yes. One or more data sets without personal identifiers will be generated during the data analysis phase of this study. The data sets will include all data underlying any publications generated by this study and therefore these will be sufficient to reproduce or verify any published findings. The final data set(s) for this study will be maintained locally at VA Providence until enterprise-level resources become available for long-term storage and access.
Related trials for Psychogenic Nonepileptic Seizures (PNES)
Recruiting
Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
Convulsion, Non-Epileptic
Recruiting
Retraining and Control Therapy (ReACT) R33 Phase
Convulsion, Non-Epileptic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan A Van Patten, PhD principal investigator
Providence VA Medical Center, Providence, RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation And Functional Treatment (CRAFT) in people with Psychogenic Nonepileptic Seizures (PNES), run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeleine R Lefkowitz, BS ((401) 127-7100 ext. 16262, Madeleine.Lefkowitz@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHODAS 2.0 Total Score (time frame: Once at baseline (prior to the intervention) and once following the 8-12 week intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.