Insomnia Clinical Trial
— CBTi 4 DS:SCEDOfficial 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: 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.
Status | Recruiting |
Enrollment | 6 |
Est. completion date | December 31, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | William Quarrier Scottish Epilepsy Centre | Glasgow |
Lead Sponsor | Collaborator |
---|---|
University of Glasgow | William Quarriers Scottish Epilepsy Centre |
United Kingdom,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 daily, from baseline to final day of post-intervention phase (day 1 up to day 21). | |
Primary | 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 daily, from baseline to final day of post-intervention phase (day 1 up to day 21). | |
Primary | 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 daily, from baseline to final day of post-intervention phase (day 1 up to day 21). | |
Primary | 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 daily, from baseline to final day of post-intervention phase (day 1 up to day 21). | |
Secondary | 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 daily, from baseline to final day of post-intervention phase (day 1 up to day 21). | |
Secondary | Insomnia Classification | Sleep Condition Indicator (SCI) score. Min score= 0 - Max= 32 with lower scores indicating poorer sleep. | Measured at day 1 and again at the end of the post-intervention phase, day 17-21. | |
Secondary | Anxiety symptoms | Generalized Anxiety Disorder Questionnaire (GAD-7) score. Min= 0 - Max= 21 with higher scores indicating more severe symptoms. | Measured at day 1 and again at the end of the post-intervention phase, day 17-21. | |
Secondary | 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 at day 1 and again at the end of the post-intervention phase, day 17-21. | |
Secondary | Attendance | Attendance of bCBTi sessions. Min = 1, max = 2. | Measured at day 1 and again at the end of the post-intervention phase, day 17-21. | |
Secondary | 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 at day 1 and again at the end of the post-intervention phase, day 17-21. | |
Secondary | 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 at day 1 and again at the end of the post-intervention phase, day 17-21. | |
Secondary | Daily dissociation | The Clinician-Administered Dissociative States Scale-6 (CADSS-6). Min = 6, max = 24, with greater scores indicating greater levels of dissociation. | Measured at day 1 and again at the end of the post-intervention phase, day 17-21. |
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