NCT02761161

Treatment of Sleep Disturbances in Trauma-affected Refugees

Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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. 1. Treatment as usual (TAU); pharmacological treatment according to algorithm and manual based Cognitive Behavioural Therapy 2. TAU and add-on treatment with mianserin 3. TAU and add-on treatment with Imagery Rehearsal Therapy (IRT) 4. TAU and add-on treatment with mianserin and IRT RESULTS: This study is expected to bring forward new knowledge on both medical and therapeutic treatment of sleep disturbances in trauma-affected refugees.

Conditions

• Post Traumatic Stress Disorder
• Depression

Interventions

Type	Name	Description
DRUG	Mianserin	mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.
BEHAVIORAL	Imagery Rehearsal Therapy	IRT is add-on treatment to treatment as usual.

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2016-05-04
• Last updated: 2019-09-16

Locations

1 site across 1 country: Denmark