Treatment of Sleep Disturbances in Trauma-affected Refugees

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborator: Danish Center for Sleep Medicine
• Treatments: Mianserin

Criteria

Inclusion Criteria:

• Adults (18 years or older)

• Refugees or persons who have been family reunified with a refugee

• PTSD pursuant to the International Classification of Diseases ICD-10 research criteria

• Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nation definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.

• Sleep disturbances/ PSQI >8

• Nightmares/ HTQ score on nightmare item ≥ "a little"

• Signed informed consent

Exclusion Criteria:

• Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Patients are excluded only if the psychotic-like experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression

• Current abuse of drugs or alcohol (F1x.24-F1x.26)

• Known neurodegenerative disorder (Alzheimer's disease (AD), Parkinson's disease (PD), Levy-Body dementia (LBD))

• In need of admission to psychiatric hospital

• Pregnant and breastfeeding women and women of the reproductive age who wish to conceive during the project period.

• Allergy towards active ingredients or excipients in mianserin

• Lack of informed consent