Assessing the Impact of Brief CBTi on Dissociative Seizures: SCED

NCT06145971 | Completed

• 1 other identifier: 331958
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (4)

• 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).

• 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).

• 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).

• 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 Outcomes (8)

• Time in bed (TIB)

  Measured daily, from baseline to final day of post-intervention phase (day 1 up to day 21).

• Insomnia Classification

  Measured at day 1 and again at the end of the post-intervention phase, day 17-21.

• Anxiety symptoms

  Measured at day 1 and again at the end of the post-intervention phase, day 17-21.

• Depressive symptoms

  Measured at day 1 and again at the end of the post-intervention phase, day 17-21.

• Attendance

  Measured at day 1 and again at the end of the post-intervention phase, day 17-21.

Study Arms (2)

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.

Behavioral: brief Cognitive Behavioural Therapy for Insomnia (bCBTi)

Interventions

brief Cognitive Behavioural Therapy for Insomnia (bCBTi) BEHAVIORAL

Two sessions of Cognitive Behavioural Therapy for Insomnia, encompassing a cognitive therapy technique and a behavioural technique as a minimum.

Intervention - bCBTi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Glasgow: lead
• William Quarriers Scottish Epilepsy Centre: collaborator

Study Sites (1)

William Quarrier Scottish Epilepsy Centre

Glasgow, G51 4QD, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 33684785 BACKGROUND

• 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.

  PMID: 27084446 BACKGROUND

• 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.

  PMID: 36451595 BACKGROUND

MeSH Terms

Conditions

Psychogenic Nonepileptic Seizures; Sleep Initiation and Maintenance Disorders; Dissociative Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Mental Disorders

Study Officials

• Dr Jessica Fish, BSc, PhD, DClinPsy

  University of Glasgow

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist, Post-Graduate Researcher

Model Details: Single Case Experimental Design (SCED) methodology using multiple baseline across participants.

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 24, 2023
• Study Start: May 6, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 29, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)