Treatment of Sleep Disturbances in Trauma-affected Refugees – A Randomised Controlled Trial
2. Project period:
Hinuga Sandahl, MD
4. Supervisors and collaborative partners:
- Principal supervisor: Associate Professor Jessica Carlsson Lohmann, CTP.
- Co-supervisor: Professor Poul Jennum, Danish Center for Sleep medicine.
- Co-supervisor: Lone Baandrup, Mental Health Center Glostrup
Sleep disturbances are often referred to as a hallmark and a core symptom of PTSD (1–5). In a sample of 832
trauma-affected refugees undergoing psychiatric treatment at Competence Centre for Transcultural
Psychiatry (CTP) in the period 2008-2012 98.9% reported sleep disturbances and 98.5% reported recurrent
nightmares (6). Studies on treatment of sleep disturbances in refugees suffering from PTSD are scarce. The
lack of studies concerning psychoeducation, psychotherapy, as well as pharmacological treatment leaves
clinicians without validated clinical guidelines for treatment of sleep disturbances (6).
The overall aim of this study is to examine sleep enhancing treatment in refugees with PTSD in a randomized
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.
7.1 Number of participants (N):
Trauma-affected refugees fulfilling the criteria for Posttraumatic Stress Disorder and
referred for treatment at CTP
7.3 Description of data and data collection:
The study will include patients from February 2016 to autumn 2017.
Patients will be randomised to one of four treatment groups: 1) Treatment as usual (TAU) in CTP (manualbased 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)
7.4 Application/acceptance from the Danish Data Protection Agency, the National Committee on
Health Research Ethics
Most outcomes are suitable for linear regression, factorial 2 x 2 ANOVA analysis with and without
relevant covariates and Full Information Maximum Likelihood (FIML) analyses (to handle missing data).
In order to analyse changes over time differences between baseline and follow-up scores can be
calculated. Potential predictors of outcome can be analysed by linear regression and by logistic
A number of explorative subgroup analyses are planned; including age, gender, average score on PSQI
and HTQ in an attempt to isolate predictors of positive outcome.
8. Expected results
The study is expected to add new knowledge on treatment of sleep disturbances in trauma-affected
9. Dissemination of results
The results will be presented at international conferences, in other settings relevant to professionals working
with trauma-affected refugees and in peer-reviewed scientific journals. Three papers are planned for:
A. Treatment effect on sleep disturbances of TAU compared to add-on treatment with mianserine, IRT
or a combination of both
B. The relation between enhanced sleep, PTSD-symptoms, physician evaluated functioning and patient
evaluated quality of life
C. Prediction of outcome of treatment depending on severity of sleep disturbances
1. Germain A. Sleep disturbances as the hallmark of PTSD: where are we now? Am J Psychiatry
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2. Nappi CM, Drummond SPA, Hall JMH. Treating nightmares and insomnia in posttraumatic stress
disorder: A review of current evidence. Neuropharmacology. 2012. p. 576–85.
3. Schoenfeld FB, Deviva JC, Manber R. Treatment of sleep disturbances in posttraumatic stress
disorder: a review. J Rehabil Res Dev [Internet]. 2012 Jan [cited 2014 Sep 10];49(5):729–52.
Available from: http://www.ncbi.nlm.nih.gov/pubmed/23015583
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epidemiology, impact and approaches to management. CNS Drugs [Internet]. 2006 Jan [cited 2014
Nov 12];20(7):567–90. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16800716
5. Spoormaker VI, Montgomery P. Disturbed sleep in post-traumatic stress disorder: secondary
symptom or core feature? Sleep Med Rev [Internet]. 2008 Jun [cited 2014 Dec 2];12(3):169–84.
Available from: http://www.ncbi.nlm.nih.gov/pubmed/18424196
6. Sandahl H, Vindbjerg E, Carlsson J. Treatment of Sleep Disturbances in Refugees Suffering from
Posttraumatic Stress Disorder. Accepted for publication, Transcultural Psychiatry 2017.
7. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new
instrument for psychiatric practice and research. Psychiatry Res [Internet]. 1989 May [cited 2014
Aug 29];28(2):193–213. Available from: http://www.ncbi.nlm.nih.gov/pubmed/2748771
8. Insana SP, Hall M, Buysse DJ, Germain A. Validation of the Pittsburgh Sleep Quality Index Addendum
for posttraumatic stress disorder (PSQI-A) in U.S. male military veterans. J Trauma Stress [Internet].
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