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

​1. Title: 

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

2. Project period: 

1.1.16-31.12.19 

3. Investigator: 

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 

5. Background 

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).

6. Aim/s 

The overall aim of this study is to examine sleep enhancing treatment in refugees with PTSD in a randomized controlled trial. The objectives are 

  1. 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 
  2. To study the relation between enhanced sleep, PTSD-symptoms, observer rated functioning and self-rated quality of life 
  3. To examine predictors for positive outcome of treatment 

7. Methods 

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): 

230 participants 

7.2 Population: 

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) (7,8). 

7.4 Application/acceptance from the Danish Data Protection Agency, the National Committee on Health Research Ethics 

Approved. 

7.5 Analysis 

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 regression. 

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 refugees. 

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 

10. References 

1. Germain A. Sleep disturbances as the hallmark of PTSD: where are we now? Am J Psychiatry [Internet]. 2013 Apr 1 [cited 2014 Sep 11];170(4):372–82. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23223954 

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 

4. Maher MJ, Rego SA, Asnis GM. Sleep disturbances in patients with post-traumatic stress disorder: 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]. 2013 Apr [cited 2014 Sep 11];26(2):192–200. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3746481&tool=pmcentrez&rendertype=abstract 

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