Competence Centre for Transcultural Psychiatry
Copenhagen, Ballerup, 2750, Denmark
NCT Number: NCT02761161
The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Copenhagen, Ballerup, 2750, Denmark
BACKGROUND:
Sleep disturbances are often referred to as a hallmark of PTSD. In a sample of 734 trauma-affected refugees undergoing psychiatric treatment at Competence Centre for Transcultural Psychiatry (CTP) in the period 2008-2012 99% reported sleep disturbances and nightmares.
In trauma-affected populations untreated sleep disturbances can uphold and exacerbate both sleep-related and non-sleep-related PTSD symptoms. Sleep disturbances may also affect the efficacy of first-line PTSD treatment and constitute a risk factor for poor outcome of psychiatric treatment. It has been argued that effective treatment of sleep disturbances may accelerate recovery in PTSD. There is a lack of randomised clinical trials on this relation in trauma-affected refugees.
The aim of this study is to examine sleep enhancing treatment in refugees with PTSD.
MATERIALS AND METHOD:
The study will include 230 refugees, diagnosed with PTSD, referred to CTP. Patients who give informed consent will be randomised to four treatment groups.
RESULTS:
This study is expected to bring forward new knowledge on both medical and therapeutic treatment of sleep disturbances in trauma-affected refugees.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.
IRT is add-on treatment to treatment as usual.
Other names: IRT
Time frame: Change from baseline after approximately 6-8 months treatment
Time frame: Change from baseline after approximately 6-8 months treatment
Time frame: Change from baseline after approximately 6-8 months treatment
Time frame: Change from baseline after approximately 6-8 months treatment
Time frame: Change from baseline after approximately 6-8 months treatment
Time frame: Change from baseline after approximately 6-8 months treatment
Time frame: 2 years
Time frame: Change from baseline after approximately 6-8 months treatment
Time frame: Change from baseline after approximately 6-8 months treatment
Time frame: Change from baseline after approximately 6-8 months treatment
Time frame: Change from baseline after approximately 6-8 months treatment
Time frame: two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Other
Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial
Acronym: PTF5
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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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