Sleep and Wellbeing Study

Sleep Clinical Trial

Official title:

Relationship Between Sleep the First Night and Week After Trauma and Subsequent Intrusive Memories: a Prospective Study From the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012685
• Other study ID #: 16/EM/0326
• Secondary ID: 195832
• Status: Completed
• Start date: November 2016
• Est. completion date: April 2018

Study information

• Verified date: January 2019
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intrusive Memories
• Posttraumatic Stress Disorder
• Sleep
• Stress Disorders, Post-Traumatic

Locations

Country	Name	City	State
United Kingdom	Emergency Department, John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Karolinska Institutet, Medical Research Council Cognition and Brain Sciences Unit

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feedback questionnaire		At 2 months
Other	Optional feedback interview		After 2 months
Primary	Daily diary of sleep and intrusive memories		1 week
Secondary	Actigraphy - to assess sleep timing and duration		1 week
Secondary	Impact of Event Scale-Revised (total score and subscales scores) - to assess post-trauma distress		At 1 week and 2 months
Secondary	Hospital Anxiety and Depression Scale		At 1 week and 2 months
Secondary	Clinician-Administered PTSD Scale		At 2 months