Sleep and Wellbeing Study

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT03012685
Collaborator
Karolinska Institutet (Other), Medical Research Council Cognition and Brain Sciences Unit (Other)
100
1
17
5.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Relationship Between Sleep the First Night and Week After Trauma and Subsequent Intrusive Memories: a Prospective Study From the Emergency Department
    Actual Study Start Date :
    Nov 1, 2016
    Actual Primary Completion Date :
    Feb 1, 2018
    Actual Study Completion Date :
    Apr 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Daily diary of sleep and intrusive memories [1 week]

    Secondary Outcome Measures

    1. Actigraphy - to assess sleep timing and duration [1 week]

    2. Impact of Event Scale-Revised (total score and subscales scores) - to assess post-trauma distress [At 1 week and 2 months]

    3. Hospital Anxiety and Depression Scale [At 1 week and 2 months]

    4. Clinician-Administered PTSD Scale [At 2 months]

    Other Outcome Measures

    1. Feedback questionnaire [At 2 months]

    2. Optional feedback interview [After 2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emergency Department, John Radcliffe Hospital Oxford Oxfordshire United Kingdom OX3 9DU

    Sponsors and Collaborators

    • University of Oxford
    • Karolinska Institutet
    • Medical Research Council Cognition and Brain Sciences Unit

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT03012685
    Other Study ID Numbers:
    • 16/EM/0326
    • 195832
    First Posted:
    Jan 6, 2017
    Last Update Posted:
    Jan 30, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 30, 2019