- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03012685
Sleep and Wellbeing Study
Relationship Between Sleep the First Night and Week After Trauma and Subsequent Intrusive Memories: a Prospective Study From the Emergency Department
Most people will experience a psychologically traumatic event, such as a life-threatening accident, at some point in their life. In the initial days after such an event, it is common to be haunted by intrusive memories: image-based memories of the event that spring to mind unbidden. Intrusive memories can be distressing in their own right, but are also a hallmark symptom of post-traumatic stress disorder (PTSD).
Sleep is important for many functions involved in how people perceive, respond to and remember events, including stressful/traumatic events. Studies with patients who have experienced traumatic events indicate that sleep disturbances in the first weeks post-trauma are associated with later PTSD symptoms. However, in a previous study with healthy volunteers exposed to experimental trauma (film footage), those who were sleep-deprived in the first night, compared to those who slept, had fewer intrusive memories in the following week. This raises the question of how sleep in the first night, but also the first week, after real-life trauma is related to subsequent intrusive memories and PTSD symptoms.
The current study is an observational study of patients recruited from a hospital emergency department after a traumatic event. After completing brief baseline questionnaires in the emergency department, participants will be asked to fill in a daily diary of their sleep and intrusive memories over the following week. Post-traumatic stress symptoms, anxiety and depression will be assessed by post/online at one week and two months. Participants will be telephoned after two months to complete an interview to assess PTSD symptoms and an optional feedback interview.
This clinical study will be the first to assess the relationship between sleep in the first night and week, and intrusive memories and mental wellbeing after real-life trauma. Findings may have implications for developing simple sleep-based preventive treatments after trauma in the future.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 9DU
- Emergency Department, John Radcliffe Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 or over
- Experienced or witnessed a traumatic event (i.e. one in which they were exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence)
- Present to the emergency department on the same day as the traumatic event
- Report memory of the event
- Fluent in written and spoken English
- Alert and orientated, Glasgow Coma Scale score (GCS) = 15
- Willing and able to give informed consent and complete study procedures
Exclusion Criteria:
- Loss of consciousness
- Current intoxication
- History of severe mental illness
- Current substance abuse or neurological condition
- Currently suicidal
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Daily diary of sleep and intrusive memories
Time Frame: 1 week
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1 week
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Actigraphy - to assess sleep timing and duration
Time Frame: 1 week
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1 week
|
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Impact of Event Scale-Revised (total score and subscales scores) - to assess post-trauma distress
Time Frame: At 1 week and 2 months
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At 1 week and 2 months
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Hospital Anxiety and Depression Scale
Time Frame: At 1 week and 2 months
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At 1 week and 2 months
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Clinician-Administered PTSD Scale
Time Frame: At 2 months
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At 2 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Feedback questionnaire
Time Frame: At 2 months
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At 2 months
|
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Optional feedback interview
Time Frame: After 2 months
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After 2 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/EM/0326
- 195832 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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