Post Traumatic Stress Disorder, Depression
Conditions
Keywords
PTSD, Sleep, Refugee, IRT, Mianserin
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.
Interventions
DRUGMianserin
mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.
BEHAVIORALImagery Rehearsal Therapy
IRT is add-on treatment to treatment as usual.
Sponsors
Danish Center for Sleep Medicine
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep on The Pittsburgh Sleep Quality Index | Change from baseline after approximately 6-8 months treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Nightmares on the Disturbing Dreams and Nightmare Severity Index | 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 |
| pain on the Brief Pain Inventory short form | Change from baseline after approximately 6-8 months treatment |
Countries
Denmark
Outcome results
None listed