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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
brief Cognitive Behavioural Therapy for Insomnia (bCBTi)
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

Other trials in United Kingdom

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
  1. Does brief CBTi (bCBTi) improve sleep difficulties in those with dissociative seizures?
  2. Does bCBTi reduce the frequency of dissociative seizures?
  3. Does bCBTi reduce self-reported levels of dissociation in participants?
  4. Does improving sleep difficulties lead to improvements in quality of life, mood and anxiety levels?
  5. 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.

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 groups in NCT06145971
Study groupRoleWhat they receive
Baseline phaseNo interventionRandomly allocated baseline phase (no intervention) of 5, 7, or 9 days.
Intervention - bCBTiExperimentalTwo 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.

  1. 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).

  2. 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).

  3. 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).

  4. 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)
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  1. First posted24 Nov 2023
  2. Study start6 May 2024
  3. Primary completion30 Dec 2024
  4. Study completion29 Mar 2025

Resources

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)
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 33684785
  • Brown 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 27084446
  • Campbell 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

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.

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