Treatment of Sleep Disturbances in Trauma-affected Refugees

Study Overview
=================
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. 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.

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

Conditions
-----------------
Post Traumatic Stress Disorder, Depression

Intervention / Treatment
-----------------
* Drug: Mianserin
* Behavioral: Imagery Rehearsal Therapy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br>TAU: medicine according to algorithm, manual-based cognitive therapy, psychoeducation | |
| Active Comparator: Mianserin<br>10-30 mg of mianserin af sleep enhancing | Drug: Mianserin<br>* mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.<br>|
| Active Comparator: Imagery Rehearsal Therapy<br>Therapy focusing on nightmares | Behavioral: Imagery Rehearsal Therapy<br>* IRT is add-on treatment to treatment as usual.<br>* Other names: IRT;|
| Active Comparator: mianserin and Imagery Rehearsal Therapy<br>Both mianserin and IRT | Drug: Mianserin<br>* mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.<br>Behavioral: Imagery Rehearsal Therapy<br>* IRT is add-on treatment to treatment as usual.<br>* Other names: IRT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep on The Pittsburgh Sleep Quality Index |  | Change from baseline after approximately 6-8 months treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nightmares on the Disturbing Dreams and Nightmare Severity Index |  | Change from baseline after approximately 6-8 months treatment | 
| Symptoms of PTSD on The Harvard Trauma Questionnaire |  | Change from baseline after approximately 6-8 months treatment | 
| Symptoms of depression and anxiety on the Hopkins Symptom Check List |  | Change from baseline after approximately 6-8 months treatment | 
| Life quality on the WHO-5 |  | Change from baseline after approximately 6-8 months treatment | 
| level of functioning on the Sheehan Disability Scale |  | Change from baseline after approximately 6-8 months treatment | 
| Sleep on the REM Sleep Behavior Disorder Screening Questionnaire |  | 2 years | 
| pain on the Brief Pain Inventory short form |  | Change from baseline after approximately 6-8 months treatment | 
| Level of functioning on the Global Assessment of functioning - Symptoms |  | Change from baseline after approximately 6-8 months treatment | 
| Level of functioning on WHODAS 2.0 |  | Change from baseline after approximately 6-8 months treatment | 
| Symptoms of depression and anxiety on Hamilton depression and anxiety scales |  | Change from baseline after approximately 6-8 months treatment | 
| Sleep on Actigraph |  | two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Sleep, Refugee, IRT, Mianserin