Trial | NCT02761161  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mianserin ...

  • Study Participants

    241
The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.
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.

Treatment as usual (TAU); pharmacological treatment according to algorithm and manual based Cognitive Behavioural Therapy
TAU and add-on treatment with mianserin
TAU and add-on treatment with Imagery Rehearsal Therapy (IRT)
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 Started
Mar 31
2016
Primary Completion
Jun 01
2019
Study Completion
Jun 01
2019
Last Update
Sep 16
2019

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.

  • Other names: IRT

Treatment as usual No Intervention

TAU: medicine according to algorithm, manual-based cognitive therapy, psychoeducation

Mianserin Active Comparator

10-30 mg of mianserin af sleep enhancing

Imagery Rehearsal Therapy Active Comparator

Therapy focusing on nightmares

mianserin and Imagery Rehearsal Therapy Active Comparator

Both mianserin and IRT

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
No Results Posted