Plain English Summary
Background and study aims
When people suffer from a dissociative disorder, their sense of reality is changed. People with this mental health condition may suffer from memory loss, and feel that their body or the world around them is not real. Sometimes they are not certain of who they are and its possible that they will also develop multiple identities. In recent studies, we found evidence that dissociative symptoms are associated with a labile (unstable) sleep-wake cycle which leads to dreamlike phenomena invading the waking state, makes them absent-mindedness, and makes dissociative symptoms worse. This theory has the potential to inspire new treatments for dissociative symptoms, that is, treatments (or interventions) that help people to have a normal sleep-wake cycle. This is important as dissociative symptoms often do not respond well to drugs or psychotherapy. Here, we want to explore whether a treatment aimed at normalising sleep can alleviate dissociative symptoms. In a previous study, we found that sleep loss can result in dissociative symptoms. Following these findings, we would like to explore whether this relation will also hold in reverse; i.e., will sleep improvement lead to a decrease of dissociative symptoms? Therefore, we will use an evidence based digital cognitive behavioural therapy (CBT) for insomnia intervention to explore whether sleep improvement reduces dissociative symptoms.
Who can participate?
Adults (aged at least 18) with dissociative symptoms and insomnia.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given immediate access to the digital cognitive behavioural therapy (CBT) for insomnia programme. Those in group 2 are given the access to the programme 5 months later. The program can be accessed via the internet and smart phone. It consist of 6 weekly sessions which takes about 20 minutes to complete. All participants in the study are asked to complete a questionnaires to explore changes in sleep and emotional health at the start of the study, after 3 weeks, 10, weeks, 22 weeks, and 33 weeks. Participation in the study does not affect the participants normal medical treatment and they are asked to continue to take their existing medication and continue with routine medical appointments throughout the duration of the study
What are the possible benefits and risks of participating?
Previous research has shown that the treatment we are offering has a large effect on improving sleep. We do not anticipate that there are any risks in taking part.
Where is the study run from?
University of Oxford, Nuffield Department of Clinical Neurosciences (UK)
When is the study starting and how long is it expected to run for?
April 2015 to March 2017
Who is funding the study?
The study is funded by a NWO Rubicon grant from The Netherlands.
Who is the main contact?
Dr. Dalena van Heugten
dalena.vanheugten@ndcn.ox.ac.uk or sleepmatterstrial@gmail.com.
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Sleep improvement and alleviation of dissociative symptoms: a randomised controlled trial of digital cognitive behavioural therapy for insomnia.
Acronym
Study hypothesis
Sleep improvement will alleviate dissociative symptoms. A secondary aim is to assess whether the relation between improved sleep and reduced dissociation is mediated by a reduction in anxiety symptoms, as both insomnia and anxiety disorders are highly correlated with dissociation
Ethics approval
University of Oxford Central University Research Ethics Committee, 27/03/2015, ref: MS-IDREC-C2 2015-006
Study design
The study is a parallel-group, randomised controlled trial of digital cognitive behavioural therapy for insomnia in addition to treatment as usual (TAU) versus TAU alone. This is a single-centre trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
We are studying the relation between insomnia symptoms and dissociative symptoms.
Intervention
This study aims to explore the causal role of sleep disturbances in the development of dissociative symptoms and their concomitants through a randomised controlled trial. We will use a well-established digital CBTi application (Sleepio.com), which has proven its efficacy in improving sleep (Espie et al., 2012), to assess whether sleep improvement alleviates dissociative symptoms. We will compare treatment as usual (control condition) to digitalised cognitive behavioural therapy for insomnia in addition to treatment as usual (experimental condition).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. To test whether delivering digital CBTi improves insomnia symptoms. Outcome measure is the Sleep Condition Indicator, administered before, during, and after the intervention
2. To test whether sleep improvement (through digital CBTi) can reduce dissociative symptoms. Outcome measures are the Dissociative Experiences Scale, and the Clinician-Administered Dissociative States Scale, administered before, during, and after the intervention
Secondary outcome measures
1. To determine whether digital CBTi improves negative affect: depression, anxiety, and stress. Outcome measures are the Depression Anxiety Stress Scales (DASS) to measure depression, anxiety, and stress administered before, during, and after the intervention
2. To determine whether changes in anxiety symptoms mediate changes in dissociative symptoms. Current statistical techniques for mediation will be employed, using the primary outcome measures at all time points
Overall trial start date
10/04/2015
Overall trial end date
25/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participant is willing and able to give informed consent for participation in the study.
2. Symptoms of insomnia, as indicated by the SCI
3. Medium-to-high level of dissociativity, as indicated by a score of 17 or more on the DES
4. Age >= 18 years (no upper limit), any gender
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
85
Participant exclusion criteria
None
Recruitment start date
20/04/2015
Recruitment end date
25/02/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford, Nuffield Department of Clinical Neurosciences
Headley Way, John Radcliffe Hospital
Level 6 West Wing
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Oxford
Sponsor details
Nuffield Department of Clinical Neurosciences
Headley Way
John Radcliffe Hospital
Level 6 West Wing
Oxford
OX3 9DU
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Dutch Organisation for Scientific Research (Nederlandse Organisatie voor Wetenschappelijk Onderzoek; NWO), The Hague, The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list