Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2026-02-27 @ 7:07 PM
Study NCT ID:
NCT02761161
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2016-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Sleep Disturbances in Trauma-affected Refugees
Sponsor:
Mental Health Services in the Capital Region, Denmark
Organization:
Study Overview
Official Title:
Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTF5
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: