Dissociative SeizuresCBTi 4 DS:SCEDNCT06145971
Assessing the Impact of Brief CBTi on Dissociative Seizures: SCED
A study testing brief Cognitive Behavioural Therapy for Insomnia (bCBTi) in people with Dissociative Seizures and Functional Seizures, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
Some people experience a temporary change in behaviour and consciousness, that often involves a collapse and/or shaking limb movements. These are referred to as 'Dissociative seizures'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dissociative Seizures, Functional Seizures, Psychogenic Nonepileptic Seizures
- What is being tested?
- brief Cognitive Behavioural Therapy for Insomnia (bCBTi)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 2024to 29 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- aged 18+ (no upper age limit);
- can speak and read English fluently;
- must score ≤16 on the Sleep Conditions Indicator (SCI);
- must demonstrate compelling evidence that at least some of their seizures are likely to be dissociative, based on at least one of the following:
- 1) Opinion of the referring consultant, WQSEC consultant, or WQSEC clinical nurse specialist, based on:
- Direct witnessing of seizure(s)
- Review of video footage
- Semiology as suggested by reliable patient or family history. 2)EEG assessment showing seizures without EEG change correlated. The participant must have received feedback that they are experiencing dissociative seizures and is accepting of this as an explanation.
Who cannot join
- active and significant mental health problems and/or moderate to severe learning disabilities (IQ score of ≤50);
- unable to give informed consent;
- non-fluent English speakers;
- current participation in another research study;
- dissociative seizures that have been assessed by the WQSEC clinical psychologist and/or consultant as potentially deliberate behaviour driven by secondary gain.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
William Quarrier Scottish Epilepsy Centre
Glasgow, G51 4QD
About this study
Official title: Assessing the Impact of Brief Cognitive Behavioural Therapy for Insomnia on Sleep Difficulties in a Dissociative Seizure Population, Using a Single-Case Experimental Design.
Some people experience a temporary change in behaviour and consciousness, that often involves a collapse and/or shaking limb movements. These are referred to as 'Dissociative seizures'. Those who experience such seizures have been found to also display high levels of dissociation, which can be described as a change in your conscious experience and may include gaps in your memory for events. It is thought that people who experience dissociative seizures also often have difficulties with their sleep. Having difficulties with sleep may make these seizures and the amount of dissociation an individual experiences worse. Greater dissociation may be additionally linked to worsening dissociative seizures. A psychological treatment for sleep difficulties called Cognitive Behavioural Therapy for Insomnia (CBTi), has been found to be effective in reducing sleep difficulties.
The main questions this study aims to answer are:
Read more
- Does brief CBTi (bCBTi) improve sleep difficulties in those with dissociative seizures?
- Does bCBTi reduce the frequency of dissociative seizures?
- Does bCBTi reduce self-reported levels of dissociation in participants?
- Does improving sleep difficulties lead to improvements in quality of life, mood and anxiety levels?
- Is bCBTi a feasible intervention to administer in an inpatient setting?
This study will investigate whether improving sleep by administering a brief version of CBTi leads to an improvement in levels of dissociation and dissociative seizure frequency. It will also investigate whether brief CBTi is a feasible treatment method for sleep difficulties in an inpatient setting.
Participants who have dissociative seizures and sleep difficulties that could be diagnosed as insomnia will be randomly assigned to a baseline phase of 5, 7 or 9 days, where they will fill out daily questionnaires on their sleep, dissociation and number of seizures. They will then begin a 10-day intervention phase where they will attend two sessions of brief CBTi, whilst also completing daily measures. This will allow us to see whether their scores on the sleep and dissociation measures improve when the intervention begins. Participants will be asked to wear an Actiwatch during the night, to gather information on their movement levels during the night. Information on changes in quality of life, mood and anxiety levels following the sleep intervention will also be collected.
Read the detailed description
Design: This study will use a Multiple Baseline Single Case Experimental Design (SCED). This design has been chosen as it can test the effectiveness of an intervention on a small number of participants. This is of benefit as it allows the piloting of a novel intervention, which brief Cognitive Behavioural Therapy for Insomnia (bCBTi) for those with dissociative seizures will be. It will involve each participant being randomly assigned to a baseline phase of three possible lengths: 5 days, 7 days and 9 days. This will be done using https://www.randomizer.org/ which will generate a random order of the three categories. During the baseline phase, sleep difficulties and levels of dissociation will be measured on a daily basis. The participant will then begin the intervention phase, where they will receive two sessions of bCBTi. Sleep difficulties and levels of dissociation will continue to be measured on a daily basis during the intervention phase. Participants can therefore serve as their own controls. The multiple baseline element controls for time as a confounding variable which increases the study's internal validity, and allows the relationship between variables to be viewed as causal rather than correlational. Guidelines for constructing good quality SCEDs have been used to inform the study protocol.
Recruitment: The study will take place at the William Quarrier Scottish Epilepsy Centre (WQSEC), recruiting current inpatients who meet the criteria for inclusion in the study. Potential participants will be identified and approached initially by the clinical nurse specialist (CNS) on the ward who has access to patient information and is alerted of any new inpatients. The CNS will provide the potential participant with an information sheet, and ask if they would consent to the principal investigator speaking to them to go through it, answer any questions and obtain informed consent. If the participant agrees to participating, the baseline measures will also be completed at this stage. Overall, the recruitment stage should take around 1 hour of participant's time over a couple of days.
Baseline phase: The participant will then enter a randomly assigned baseline phase of 5, 7 or 9 days in length, which will involve them completing two short measures on a daily basis and wearing an actiwatch during the night. It will take around 10-15 minutes to complete the measures each day. Nursing and/or Health Care Assistants on the ward may assist with prompting participants to complete the measures throughout the duration of the study if they have capacity in addition to their primary clinical duties.
Intervention phase: Once they have completed their baseline phase, they will begin the intervention phase, which will involve attending two sessions of bCBTi with a clinical psychologist on the ward. Each session will last between an hour to an hour and a half. The sessions will be three days apart, one on a Monday and one on a Friday. The participants will continue to complete daily measures during this time, and will continue to wear the actiwatches.
Post-intervention phase and study completion: Following the two sessions of bCBTi, the participants will continue to complete the daily measures and wear the actiwatch for 7 days. Following this, the principal investigator will meet with the participants to complete the post intervention measures, which are the same as the pre-intervention measures. At this meeting, the principal investigator will also debrief the participants on the study. This meeting will take around an hour.
- Conditions
- Dissociative Seizures, Functional Seizures, Psychogenic Nonepileptic Seizures, Insomnia, Dissociation, Sleep Disorder
- Being tested
- brief Cognitive Behavioural Therapy for Insomnia (bCBTi)
- Keywords
- dissociative seizures, SCED, insomnia, functional seizures, psychogenic nonepileptic seizures, sleep disorder, dissociation
- Medical subject headings
- Psychogenic Nonepileptic Seizures, Sleep Initiation and Maintenance Disorders, Dissociative Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief Cognitive Behavioural Therapy for Insomnia (bCBTi)Behavioural
Two sessions of Cognitive Behavioural Therapy for Insomnia, encompassing a cognitive therapy technique and a behavioural technique as a minimum.
| Study group | Role | What they receive |
|---|---|---|
| Baseline phase | No intervention | Randomly allocated baseline phase (no intervention) of 5, 7, or 9 days. |
| Intervention - bCBTi | Experimental | Two sessions of brief Cognitive Behavioural Therapy for insomnia (bCBTi). This will involve a clinical psychologist meeting with the participant for two sessions, three days apart, to provide bCBTi, which will involve a cognitive and a behavioural therapy technique. Receives: Behavioral: brief Cognitive Behavioural Therapy for Insomnia (bCBTi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time (TST)
Total time spent asleep in bed in minutes. Measured using actigraphy and a sleep diary completed by the participant. Higher scores indicated longer time spent asleep.
Measured: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).
Wake after sleep onset (WASO)
Total time spent awake after sleep onset in minutes. Measured using actigraphy and a sleep diary completed by the participant. Higher scores indicate longer time spent awake.
Measured: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).
Number of night time awakenings
Total number of awakenings during the night. Measured using actigraphy and a sleep diary completed by the participant. Min = 0 - no Max. Lower scores indicate fewer night time awakenings.
Measured: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).
Sleep onset latency (SOL)
Time taken to fall asleep in minutes measured using actigraphy and a sleep diary completed by the participant. Higher scores indicate greater SOL.
Measured: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).
Secondary outcomes (8)
Time in bed (TIB)
Total time spent in bed in minutes with higher scores indicating longer time spent in bed. Measured using a sleep diary completed by the participant.
Measured: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).
Insomnia Classification
Sleep Condition Indicator (SCI) score. Min score= 0 - Max= 32 with lower scores indicating poorer sleep.
Measured: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Anxiety symptoms
Generalized Anxiety Disorder Questionnaire (GAD-7) score. Min= 0 - Max= 21 with higher scores indicating more severe symptoms.
Measured: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Depressive symptoms
The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E). 6-item self-report questionnaire, min = 6, max = 24. Greater scores indicate more severe symptoms.
Measured: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Attendance
Attendance of bCBTi sessions. Min = 1, max = 2.
Measured: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Quality of Life
Patient Weighted Quality of Life in Epilepsy (QoLIE-10-P). Min = 10, max = 51 with greater scores indicating lower quality of life.
Measured: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Dissociation
Dissociative Experiences Scale-II (DES-II), a 28-item questionnaire where items are measured on the percentage of time each item is experienced (0-100%). Scores ≥30 indicate the presence of a dissociative disorder.
Measured: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Daily dissociation
The Clinician-Administered Dissociative States Scale-6 (CADSS-6). Min = 6, max = 24, with greater scores indicating greater levels of dissociation.
Measured: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start6 May 2024
- Primary completion30 Dec 2024
- Study completion29 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dissociative SeizuresStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Model description
- Single Case Experimental Design (SCED) methodology using multiple baseline across participants.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- William Quarriers Scottish Epilepsy Centre
- Responsible party
- Principal investigator, Sarah Adam, University of Glasgow
- Investigators
- Dr Jessica Fish, BSc, PhD, DClinPsy, Study director, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145971
- Sponsor's protocol ID
- 331958
- Other IDs
- 331958
- Acronym
- CBTi 4 DS:SCED
- Status last verified
- Mar 2025
- First submitted
- 10 Nov 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD.
Publications
Mousa S, Latchford G, Weighall A, Nash H, Murray-Leslie R, Reuber M, Relton SD, Graham CD. Evidence of objective sleep impairment in nonepileptic attack disorder: A naturalistic prospective controlled study using actigraphy and daily sleep diaries over six nights. Epilepsy Behav. 2021 Apr;117:107867. doi: 10.1016/j.yebeh.2021.107867. Epub 2021 Mar 5.
PubMed 33684785Brown RJ, Reuber M. Psychological and psychiatric aspects of psychogenic non-epileptic seizures (PNES): A systematic review. Clin Psychol Rev. 2016 Apr;45:157-82. doi: 10.1016/j.cpr.2016.01.003. Epub 2016 Mar 16.
PubMed 27084446Campbell MC, Smakowski A, Rojas-Aguiluz M, Goldstein LH, Cardena E, Nicholson TR, Reinders AATS, Pick S. Dissociation and its biological and clinical associations in functional neurological disorder: systematic review and meta-analysis. BJPsych Open. 2022 Dec 1;9(1):e2. doi: 10.1192/bjo.2022.597.
PubMed 36451595
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Brief Cognitive Behavioural Therapy for Insomnia on Sleep Difficulties in a Dissociative Seizure Population, Using a Single-Case Experimental Design.
- ClinicalTrials.gov ID
- NCT06145971
- Acronym / sponsor ID
- CBTi 4 DS:SCED / 331958
- Conditions
- Dissociative Seizures, Functional Seizures, Psychogenic Nonepileptic Seizures, Insomnia, Dissociation, Sleep Disorder
- Keywords
- dissociative seizures, SCED, insomnia, functional seizures, psychogenic nonepileptic seizures, sleep disorder, dissociation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- William Quarriers Scottish Epilepsy Centre
- Study start
- 6 May 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 29 Mar 2025 (actual)
- First posted
- 24 Nov 2023 (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.
Some people experience a temporary change in behaviour and consciousness, that often involves a collapse and/or shaking limb movements. These are referred to as 'Dissociative seizures'. Those who experience such seizures have been found to also display high levels of dissociation, which can be described as a change in your conscious experience and may include gaps in your memory for events. It is thought that people who experience dissociative seizures also often have difficulties with their sleep. Having difficulties with sleep may make these seizures and the amount of dissociation an individual experiences worse. Greater dissociation may be additionally linked to worsening dissociative seizures. A psychological treatment for sleep difficulties called Cognitive Behavioural Therapy for Insomnia (CBTi), has been found to be effective in reducing sleep difficulties.
The main questions this study aims to answer are:
- Does brief CBTi (bCBTi) improve sleep difficulties in those with dissociative seizures?
- Does bCBTi reduce the frequency of dissociative seizures?
- Does bCBTi reduce self-reported levels of dissociation in participants?
- Does improving sleep difficulties lead to improvements in quality of life, mood and anxiety levels?
- Is bCBTi a feasible intervention to administer in an inpatient setting?
This study will investigate whether improving sleep by administering a brief version of CBTi leads to an improvement in levels of dissociation and dissociative seizure frequency. It will also investigate whether brief CBTi is a feasible treatment method for sleep difficulties in an inpatient setting.
Participants who have dissociative seizures and sleep difficulties that could be diagnosed as insomnia will be randomly assigned to a baseline phase of 5, 7 or 9 days, where they will fill out daily questionnaires on their sleep, dissociation and number of seizures. They will then begin a 10-day intervention phase where they will attend two sessions of brief CBTi, whilst also completing daily measures. This will allow us to see whether their scores on the sleep and dissociation measures improve when the intervention begins. Participants will be asked to wear an Actiwatch during the night, to gather information on their movement levels during the night. Information on changes in quality of life, mood and anxiety levels following the sleep intervention will also be collected.
Detailed description
Design: This study will use a Multiple Baseline Single Case Experimental Design (SCED). This design has been chosen as it can test the effectiveness of an intervention on a small number of participants. This is of benefit as it allows the piloting of a novel intervention, which brief Cognitive Behavioural Therapy for Insomnia (bCBTi) for those with dissociative seizures will be. It will involve each participant being randomly assigned to a baseline phase of three possible lengths: 5 days, 7 days and 9 days. This will be done using https://www.randomizer.org/ which will generate a random order of the three categories. During the baseline phase, sleep difficulties and levels of dissociation will be measured on a daily basis. The participant will then begin the intervention phase, where they will receive two sessions of bCBTi. Sleep difficulties and levels of dissociation will continue to be measured on a daily basis during the intervention phase. Participants can therefore serve as their own controls. The multiple baseline element controls for time as a confounding variable which increases the study's internal validity, and allows the relationship between variables to be viewed as causal rather than correlational. Guidelines for constructing good quality SCEDs have been used to inform the study protocol.
Recruitment: The study will take place at the William Quarrier Scottish Epilepsy Centre (WQSEC), recruiting current inpatients who meet the criteria for inclusion in the study. Potential participants will be identified and approached initially by the clinical nurse specialist (CNS) on the ward who has access to patient information and is alerted of any new inpatients. The CNS will provide the potential participant with an information sheet, and ask if they would consent to the principal investigator speaking to them to go through it, answer any questions and obtain informed consent. If the participant agrees to participating, the baseline measures will also be completed at this stage. Overall, the recruitment stage should take around 1 hour of participant's time over a couple of days.
Baseline phase: The participant will then enter a randomly assigned baseline phase of 5, 7 or 9 days in length, which will involve them completing two short measures on a daily basis and wearing an actiwatch during the night. It will take around 10-15 minutes to complete the measures each day. Nursing and/or Health Care Assistants on the ward may assist with prompting participants to complete the measures throughout the duration of the study if they have capacity in addition to their primary clinical duties.
Intervention phase: Once they have completed their baseline phase, they will begin the intervention phase, which will involve attending two sessions of bCBTi with a clinical psychologist on the ward. Each session will last between an hour to an hour and a half. The sessions will be three days apart, one on a Monday and one on a Friday. The participants will continue to complete daily measures during this time, and will continue to wear the actiwatches.
Post-intervention phase and study completion: Following the two sessions of bCBTi, the participants will continue to complete the daily measures and wear the actiwatch for 7 days. Following this, the principal investigator will meet with the participants to complete the post intervention measures, which are the same as the pre-intervention measures. At this meeting, the principal investigator will also debrief the participants on the study. This meeting will take around an hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single Case Experimental Design (SCED) methodology using multiple baseline across participants.
| Arm | Type | Receives |
|---|---|---|
| Baseline phase | No intervention | –Randomly allocated baseline phase (no intervention) of 5, 7, or 9 days. |
| Intervention - bCBTi | Experimental | Behavioral: brief Cognitive Behavioural Therapy for Insomnia (bCBTi)Two sessions of brief Cognitive Behavioural Therapy for insomnia (bCBTi). This will involve a clinical psychologist meeting with the participant for two sessions, three days apart, to provide bCBTi, which will involve a cognitive and a behavioural therapy technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aged 18+ (no upper age limit);
- can speak and read English fluently;
- must score ≤16 on the Sleep Conditions Indicator (SCI);
- must demonstrate compelling evidence that at least some of their seizures are likely to be dissociative, based on at least one of the following:
- 1) Opinion of the referring consultant, WQSEC consultant, or WQSEC clinical nurse specialist, based on:
Key exclusion criteria (5 listed)
- active and significant mental health problems and/or moderate to severe learning disabilities (IQ score of ≤50);
- unable to give informed consent;
- non-fluent English speakers;
- current participation in another research study;
- dissociative seizures that have been assessed by the WQSEC clinical psychologist and/or consultant as potentially deliberate behaviour driven by secondary gain.
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 |
|---|---|---|
| brief Cognitive Behavioural Therapy for Insomnia (bCBTi)Two sessions of Cognitive Behavioural Therapy for Insomnia, encompassing a cognitive therapy technique and a behavioural technique as a minimum. | Behavioural | Intervention - bCBTi |
Primary outcome
Total Sleep Time (TST)
Time frame: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).
Total time spent asleep in bed in minutes. Measured using actigraphy and a sleep diary completed by the participant. Higher scores indicated longer time spent asleep.
Wake after sleep onset (WASO)
Time frame: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).
Total time spent awake after sleep onset in minutes. Measured using actigraphy and a sleep diary completed by the participant. Higher scores indicate longer time spent awake.
Number of night time awakenings
Time frame: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).
Total number of awakenings during the night. Measured using actigraphy and a sleep diary completed by the participant. Min = 0 - no Max. Lower scores indicate fewer night time awakenings.
Sleep onset latency (SOL)
Time frame: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).
Time taken to fall asleep in minutes measured using actigraphy and a sleep diary completed by the participant. Higher scores indicate greater SOL.
8 secondary outcomes
Time in bed (TIB)
Time frame: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).
Insomnia Classification
Time frame: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Anxiety symptoms
Time frame: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Depressive symptoms
Time frame: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Attendance
Time frame: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Quality of Life
Time frame: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Dissociation
Time frame: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Daily dissociation
Time frame: Measured at day 1 and again at the end of the post-intervention phase, day 17-21.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 33684785Mousa S, Latchford G, Weighall A, Nash H, Murray-Leslie R, Reuber M, Relton SD, Graham CD. Evidence of objective sleep impairment in nonepileptic attack disorder: A naturalistic prospective controlled study using actigraphy and daily sleep diaries over six nights. Epilepsy Behav. 2021 Apr;117:107867. doi: 10.1016/j.yebeh.2021.107867. Epub 2021 Mar 5.
- Background: PubMed 27084446Brown RJ, Reuber M. Psychological and psychiatric aspects of psychogenic non-epileptic seizures (PNES): A systematic review. Clin Psychol Rev. 2016 Apr;45:157-82. doi: 10.1016/j.cpr.2016.01.003. Epub 2016 Mar 16.
- Background: PubMed 36451595Campbell MC, Smakowski A, Rojas-Aguiluz M, Goldstein LH, Cardena E, Nicholson TR, Reinders AATS, Pick S. Dissociation and its biological and clinical associations in functional neurological disorder: systematic review and meta-analysis. BJPsych Open. 2022 Dec 1;9(1):e2. doi: 10.1192/bjo.2022.597.
- Individual participant dataSharing planned: No. No plans to share IPD.
Related trials for Dissociative Seizures
RecruitingEarly Phase 1
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
Functional Neurological Symptom Disorder, Functional Seizures
Active, not recruitingObservational study
Study on the Rapid Diagnostic Value of Sudden Clap Provocation Test in Psychogenic Nonepileptic Seizures
Epilepsy, Psychogenic Non-epileptic Seizures
Recruiting
Retraining and Control Therapy (ReACT)- Adults
Convulsion, Non-Epileptic
Recruiting
A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures
Functional Seizures, Convulsion, Non-Epileptic
Recruiting
Cognitive Rehabilitation for Veterans With PNES
Psychogenic Nonepileptic Seizures (PNES)
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. This study is not recruiting at the moment.
Dr Jessica Fish, BSc, PhD, DClinPsy study director
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief Cognitive Behavioural Therapy for Insomnia (bCBTi) in people with Dissociative Seizures and Functional Seizures, run by University of Glasgow at 1 site in United Kingdom.
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 5 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: finished, as of the sponsor's last update on 3 Apr 2025. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (TST) (time frame: Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145971, which also lists 3 linked publications.
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 3 Apr 2025.