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Region Hovedstaden - en del af Københavns Universitetshospital

PTF5: Treatment of Sleep Disturbances in Trauma-affected Refugees – A Randomised Controlled Trial

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Introduction:Sleep disturbances are often referred to as a hallmark of PTSD. In a sample of 752 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 overall aim of this study is to examine sleep enhancing treatment in refugees with PTSD in a randomized controlled trial. The objectives are:
- To estimate treatment effects of Imagery Rehearsal therapy (IRT) and mianserine on sleep quality, sleep length and nightmares compared to treatment as usual (TAU) in CTP.
- To study the relation between enhanced sleep, PTSD-symptoms, observer rated functioning and self-rated quality of life.
- To examine predictors for positive outcome of treatment.

The study is a pragmatic randomized controlled trial, performed in a clinical setting in a psychiatric outpatient clinic, over a two year period.
The design has a 2x2 factorial design. The allocation ratio to the four groups are 1:1:1:1.
Number of participants is 230, who are trauma-affected refugees fulfilling the criteria for Posttraumatic Stress Disorder and referred for treatment at CTP.
Patients will be randomised to one of four treatment groups: 1) Treatment as usual (TAU) in CTP (manual-based Cognitive Behavioural Therapy, medicine according to algorithm and psychoeducation). 2) TAU and add-on treatment with mianserine. 3) TAU and add-on treatment with IRT. 4) TAU and add-on treatment with mianserine and IRT.
The primary outcome in this trial is sleep disturbances measured on Pittsburgh Sleep Quality Index (PSQI).

Inclusion criteria
Adults (18 years or older).
Refugees or persons who have been family reunified with a refugee.
PTSD pursuant to the ICD-10 research criteria.
Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the UN 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 neurodegenative 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.

Expected Results: 
This study is expected to bring forward new knowledge on both medical and therapeutic treatment of sleep disturbances in trauma-affected refugees as well as knowledge on predictors of treatment outcome and knowlegde on individual sleep patters measured by smart watches.
Expected Impact:We expect that findings from the project will inform the future treatment of PTSD, especially concerning symptoms of sleep disturbances and nightmares.



  • Sundhedsvidenskab - Trauma and Stressor Related Disorders, including traumatic experience in childhood, Pharmacology, Randomized Controlled Clinical Trial, Psychotherapy, Transcultural Psychiatry

ID: 46196836