An observational study in PTSD and Sleep Disorder, sponsored by Mental Health Services in the Capital Region, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Mental Health Services in the Capital Region, Denmark · Observational
The aim of this study is to examine sleep architecture in refugees with PTSD. Polysomnography (PSG) will be carried out to study the occurrence of sleep disorders in patients and healthy controls.
There is little knowledge on treatment of sleep disturbances in trauma-affected refugees and this study will be the first to record the biophysiological changes that occur during sleep in refugees with PTSD. The study is a proof-of-concept study and this will contribute with new and potentially crucial knowledge of sleep disturbances in these patients.
The project is designed as a cross-sectional study with 20 refugees with PTSD referred to the specialised outpatient clinic, Competence Centre for Transcultural Psychiatry (CTP), and 20 healthy control subjects.
All patients referred to CTP will be invited to an initial consultation with a doctor. During this consultation a diagnostic assessment will be performed and the clinical history will be obtained. Patients who give informed consent will be invited to participate in the project and have sleep measurements performed by PSG. Furthermore self-administered questionnaires and semi-structured interviews will be used to collect information on mental health, sleep quality, sleep length and nightmares.
Each patient will be equipped with PSG equipment to do measurements at home for one night (12 hours). Healthy control subjects will fill out the same CTP standard ratings and have the same diagnostic assessment and PSG measurement.
The hypothesis is that the sleep architecture in refugees with PTSD differ from healthy controls. It is suggested that refugees with PTSD have increased dream activity as well as increased incidence of sleep disorders such as rapid eye movement (REM) sleep without atonia (RSWA), REM sleep behaviour disorder (RBD), sleep apnea and periodic limb movement disorder (PLM).
The study is performed in collaboration with Danish Centre for Sleep Medicine in Denmark.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 40 is below the median of 114 across 215 observational studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Mental Health Services in the Capital Region, Denmark is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
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The study population includes patients referred to the specialised outpatient clinic 'Competence Centre for Transcultural Psychiatry' (CTP) in Denmark. The clinic treats adult refugees, migrants or people with family reunification who has a traumatic background eg. imprisonment with torture, organised violence, long term political pursuit or war experiences. The patients at the clinic has PTSD, depression and/or anxiety.
Healthy control subjects are matched on age, sex and BMI.
Exclusion Criteria:
Adults over the age of 18. Refugees or family members of refugees that has been reunited. PTSD (ICD-10 criteria) and written consent. No drug or alcohol abuse and no medication that can affect sleep rhythms, such as antipsychotic drugs, benzodiazepine, opioids, antihistamine or CNS stimulating drugs. A BMI under 35 and no pregnancy.
Other: Polysomnography
Matched on age, sex and BMI and signed written consent. No mental illness, drug or alcohol abuse and medication. No pregnancy.
Other: Polysomnography
Sleep architecture will be assessed by polysomnography
Assessing the incidence of sleep disorders in refugees with PTSD
Sleep architecture will be assessed by polysomnography. The recording of brain activity during sleep will reveal the incidence of sleep disorders such as sleep apnea, REM sleep without atonia and REM sleep behaviour disorder
Time frame: 12 hours
Global Assessment of Functioning (GAF S + F)
A numeric scale used to subjectively rate the social, occupational, and psychological functioning of an individual
Time frame: 10 minutes
Harvard Trauma Questionnaire (HTQ)
Assessing PTSD symptoms
Time frame: 10 minutes
Hopkins Symptom Check List-25 (HSCL-25)
Assessing anxiety and depression symptoms
Time frame: 10 minutes
World Health Organization Well-Being Index (WHO-5)
Assessing subjective psychological well-being
Time frame: 10 minutes
Sheehan Disability Scale (SDS)
The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Total score 0-30 (0 unimpaired, 30 highly impaired). Work/school (0-10), Social life (0-10), Family life/home responsibilities (0-10). Scores of ≥5 on any of the 3 scales; high scores are associated with significant functional impairment.
Time frame: 10 minutes
Schedule for Clinical Assessment in Neuropsychiatry (SCAN)
Diagnosing and measuring mental illness that may occur in adult life.
Time frame: 1 hours
Clinician Administered PTSD Scale (CAPS-5)
Assessing PTSD symptoms, including their frequency and severity. The gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview and requires the identification of a single index trauma to serve as the basis of symptom inquiry. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. A patient needs to have: at least one Criterion B and C symptom and at least two Criterion D and E symptoms. Criterion F is met (disturbance has lasted one month) and Criterion G is met (disturbance causes either clinically significant distress or functional impairment).
Time frame: 1 hour
Hamilton depression scale (HAM-D17)
Assessing a patient's severity of depression before, during, and after treatment. The HAM-D probes 17 parameters. Some items are scored on a 5-point scale, ranging from 0=not present to 4=severe; others are scored on a 3-point scale, ranging from 0=not present to 2=severe. Total score 0-52 (0 unimpaired, 52 highly impaired). The sum of all 17 items indicate the severity of depression; 0-12 = normal, 13-17 = mild depression, 18-24 = moderate depression, 24-52 severe depression.
Time frame: 15 minutes
Hamilton anxiety scale (HAM-A14)
Assessing the severity of a patient's anxiety. The HAM-A probes 14 items. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Total score 0-56 (0 unimpaired, 56 highly impaired). The sum of all 14 items indicate the severity of anxiety; 14-17 = mild anxiety, 18-24 = moderate anxiety, 25-30 severe anxiety.
Time frame: 15 minutes
The Pittsburgh Sleep Quality Index (PSQI)
Assessing sleep quality and sleep disorders
Time frame: 10 minutes
Disturbing dreams and Nightmare Severity Index (DDNSI)
Assessing nightmares
Time frame: 10 minutes
REM Sleep Behavior Disorder Screening Questionnaire (RBDSC)
Assessing REM Sleep Behavior Disorders
Time frame: 10 minutes
Life Events Checklist for DSM-5 (LEC-5) - extended version
Screening of potential traumatic events
Time frame: 10 minutes
Plan to share: No
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Mental Health Services in the Capital Region, Denmark