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Completed

NCT Number: NCT03012685

Sleep and Wellbeing Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Department, John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Daily diary of sleep and intrusive memories

    Time frame: 1 week

Secondary outcomes

  1. Actigraphy - to assess sleep timing and duration

    Time frame: 1 week

  2. Impact of Event Scale-Revised (total score and subscales scores) - to assess post-trauma distress

    Time frame: At 1 week and 2 months

  3. Hospital Anxiety and Depression Scale

    Time frame: At 1 week and 2 months

  4. Clinician-Administered PTSD Scale

    Time frame: At 2 months

Other outcomes

  1. Feedback questionnaire

    Time frame: At 2 months

  2. Optional feedback interview

    Time frame: After 2 months

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Karolinska Institutet
  • Medical Research Council Cognition and Brain Sciences Unit

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2017
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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