Sleep and Wellbeing Study

NCT03012685 | Completed

• 2 other identifiers: 16/EM/0326195832
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Intrusive Memories; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Daily diary of sleep and intrusive memories

  1 week

Secondary Outcomes (4)

• Actigraphy - to assess sleep timing and duration

  1 week

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

  At 1 week and 2 months

• Hospital Anxiety and Depression Scale

  At 1 week and 2 months

• Clinician-Administered PTSD Scale

  At 2 months

Other Outcomes (2)

• Feedback questionnaire

  At 2 months

• Optional feedback interview

  After 2 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the John Radcliffe Hospital Emergency Department after a traumatic event.

You may qualify if:

• 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

You may not qualify if:

• Loss of consciousness
• Current intoxication
• History of severe mental illness
• Current substance abuse or neurological condition
• Currently suicidal

Sponsors & Collaborators

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

Study Sites (1)

Emergency Department, John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (1)

• Porcheret K, Iyadurai L, Bonsall MB, Goodwin GM, Beer SA, Darwent M, Holmes EA. Sleep and intrusive memories immediately after a traumatic event in emergency department patients. Sleep. 2020 Aug 12;43(8):zsaa033. doi: 10.1093/sleep/zsaa033.

  PMID: 32133531 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: January 6, 2017
• Study Start: November 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)