Top

Trials

Published in:

Open Access 01-12-2017 | Study protocol

Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial

Authors: Hinuga Sandahl, Poul Jennum, Lone Baandrup, Ida Sophie Poschmann, Jessica Carlsson

Published in: Trials | Issue 1/2017

Abstract

Background

Sleep disturbances are often referred to as a hallmark and as core symptoms of post-traumatic stress disorder (PTSD). Untreated sleep disturbances can contribute to the maintenance and exacerbation of PTSD symptoms, which may diminish treatment response and constitute a risk factor for poor treatment outcome. Controlled trials on treatment of sleep disturbances in refugees suffering from PTSD are scarce. The present study aims to examine sleep-enhancing treatment in refugees with PTSD. We aim to assess if add-on treatment with mianserin and/or Imagery Rehearsal Therapy (IRT) to treatment as usual (TAU) for PTSD improves sleep disturbances. We will study the relation between sleep disturbances, PTSD symptoms, psychosocial functioning and quality of life.

Methods

The study is a randomised controlled superiority trial with a 2 × 2 factorial design. The study will include 230 trauma-affected refugees.

The patients are randomised into four groups. All four groups receive TAU – an interdisciplinary treatment approach covering a period of 6–8 months with pharmacological treatment, physiotherapy, psychoeducation and manual-based cognitive behavioural therapy within a framework of weekly sessions with a physician, physiotherapist or psychologist. One group receives solely TAU, serving as a control group, while the three remaining groups are active-treatment groups receiving add-on treatment with either mianserin, IRT or a combination of both.

Treatment outcome is evaluated using self-administered rating scales, observer ratings and actigraph measurements at baseline, during treatment and post treatment. The primary outcome is subjective sleep quality using the Pittsburgh Sleep Quality Index. Secondary outcome measures are objective sleep length, nightmares, PTSD severity, symptoms of depression and anxiety, pain, quality of life and psychosocial functioning.

Discussion

This trial will be the first randomised controlled trial to examine sleep-enhancing treatment in trauma-affected refugees, as well as the first trial to investigate the effect of IRT and mianserin in this population. Therefore, this trial may optimise treatment recommendations for sleep disturbances in trauma-affected refugees. Based on our findings, we expect to discuss the effect of treatment, focussing on sleep disturbances. Furthermore, the results will provide new information regarding the association between sleep disturbances, PTSD symptoms, psychosocial functioning and quality of life in trauma-affected refugees.

Trial registration

EudraCT registration under the name ‘Treatment of sleep disturbances in trauma-affected refugees – a randomised controlled trial’, registration number: 2015-004153-40, registered on 13 November 2015.

ClinicalTrials.gov, ID: NCT02761161. Registered on 27 April 2016.

Available only for authorised users

UNHCR. Global trends forced displacement in 2016. 2016;10(1):39–45. Available from: http://www.unhcr.org/statistics/unhcrstats/5943e8a34/global-trends-forced-displacement-2016.html. Accessed 2 Aug 2017.

Boynton L, Bentley J, Strachan E, Barbato A, Raskind M. Preliminary findings concerning the use of prazosin for the treatment of posttraumatic nightmares in a refugee population. J Psychiatr Pract. 2009;15(6):454–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19934720. Accessed 11 Sept 2014.CrossRefPubMed

Steel Z, Chey T, Silove D, Marnane C, Bryant RA, van Ommeren M. Association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis. JAMA. 2009;302:537–49.CrossRefPubMed

Buhmann CB. Traumatized refugees: morbidity, treatment and predictors of outcome. Dan Med J. 2014;61(8):B4871. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25162447. Accessed 14 Dec 2014.PubMed

Sonne C, Carlsson J, Bech P, Mortensen EL. Pharmacological treatment of refugees with trauma-related disorders: what do we know today? Transcult Psychiatry. 2017;54(2):260–80. Available from: http://journals.sagepub.com/doi/10.1177/1363461516682180. Accessed 2 Aug 2017.

Crumlish N, O’Rourke K. A systematic review of treatments for post-traumatic stress disorder among refugees and asylum-seekers. J Nerv Ment Dis. 2010;198(4):237–51. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20386252. Accessed 17 Dec 2014.CrossRefPubMed

Palic S, Elklit A. Psychosocial treatment of posttraumatic stress disorder in adult refugees: a systematic review of prospective treatment outcome studies and a critique. J Affect Disord. 2011;131(1–3):8–23. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20708804. Accessed 6 Dec 2014.CrossRefPubMed

Germain A. Sleep disturbances as the hallmark of PTSD: where are we now? Am J Psychiatry. 2013;4:372–82. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23223954. Accessed 11 Sept 2014.CrossRef

Nappi CM, Drummond SPA, Hall JMH. Treating nightmares and insomnia in posttraumatic stress disorder: a review of current evidence. Neuropharmacology. 2012;62:576–85.CrossRefPubMed

10.

Schoenfeld FB, Deviva JC, Manber R. Treatment of sleep disturbances in posttraumatic stress disorder: a review. J Rehabil Res Dev. 2012;49(5):729–52. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23015583. Accessed 10 Sept 2014.CrossRefPubMed

11.

Maher MJ, Rego SA, Asnis GM. Sleep disturbances in patients with post-traumatic stress disorder: epidemiology, impact and approaches to management. CNS Drugs. 2006;20(7):567–90. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16800716. Accessed 12 Nov 2014.CrossRefPubMed

12.

Spoormaker VI, Montgomery P. Disturbed sleep in post-traumatic stress disorder: secondary symptom or core feature? Sleep Med Rev. 2008;12(3):169–84. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18424196. Accessed 2 Dec 2014.CrossRefPubMed

13.

Brownlow JA, Harb GC, Ross RJ. Treatment of sleep disturbances in post-traumatic stress disorder: a review of the literature. Curr Psychiatry Rep. 2015;17(6):41. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25894359. Accessed 6 Sept 2016.CrossRefPubMed

14.

Sandahl H, Vindbjerg E, Carlsson J. Treatment of sleep disturbances in refugees suffering from posttraumatic stress disorder. Accepted for publication Transcult Psychiatry. 2016.

15.

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. American Psychiatric Association. 2013. Available from: http://psychiatryonline.org/doi/book/10.1176/appi.books.9780890425596. Accessed 22 Nov 2016.

16.

Zayfert C, DeViva JC. Residual insomnia following cognitive behavioral therapy for PTSD. J Trauma Stress. 2004;17(1):69–73. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15027796. Accessed 7 Aug 2017.CrossRefPubMed

17.

Jennum P, Bonke J, Clark AJ, Flyvbjerg A, Garde AH, Hermansen K, et al. Søvn og sundhed. Videnråd for forebyggelse. 2015. Available from: http://www.vidensraad.dk/sites/default/files/vidensraad_soevn-og-sundhed_digital.pdf. Accessed 16 July 2015.

18.

Lipinska G, Baldwin DS, Thomas KGF. Pharmacology for sleep disturbance in PTSD. Hum Psychopharmacol. 2016;31(2):156–63.CrossRefPubMed

19.

Aurora RN, Zak RS, Auerbach SH, Casey KR, Chowdhuri S, Karippot A, Morgenthaler, TI, et al. Best practice guide for the treatment of nightmare disorder in adults. J Clin Sleep Med. 2010;6:389–401.

20.

Byers MG, Allison KM, Wendel CS, Lee JK. Prazosin versus quetiapine for nighttime posttraumatic stress disorder symptoms in veterans: an assessment of long-term comparative effectiveness and safety. J Clin Psychopharmacol. 2010;30(3):225–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20473055. Accessed 22 Aug 2014.CrossRefPubMed

21.

Mayers AG, Baldwin DS. Antidepressants and their effect on sleep. Hum Psychopharmacol. 2005;20(8):533–59. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16229049. Accessed 29 Dec 2015.CrossRefPubMed

22.

Peet M, Behagel H. Mianserin: a decade of scientific development. Br J Clin Pharmacol. 1978;5 Suppl 1:5S–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/623702. Accessed 2 Nov 2016.

23.

Ferreri M, Lavergne F, Berlin I, Payan C, Puech AJ. Benefits from mianserin augmentation of fluoxetine in patients with major depression non-responders to fluoxetine alone. Acta Psychiatr Scand. 2008;103(1):66–72. Available from: http://doi.wiley.com/10.1111/j.1600-0447.2001.00148.x. Accessed 12 Jun 2017.

24.

Buhmann C, Mortensen EL, Nordentoft M, Ryberg J, Ekstrøm M. Follow-up study of the treatment outcomes at a psychiatric trauma clinic for refugees. Torture. 2015;25(1):1–16. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26021344. Accessed 10 Jun 2015.

25.

Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008;4(5):487–504. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2576317&tool=pmcentrez&rendertype=abstract. Accessed 5 May 2015.PubMedPubMedCentral

26.

Harb GC, Phelps AJ, Forbes D, Ross RJ, Gehrman PR, Cook JM. A critical review of the evidence base of imagery rehearsal for posttraumatic nightmares: pointing the way for future research. J Trauma Stress. 2013;26(5):570–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24114887. Accessed 12 Nov 2014.CrossRefPubMed

27.

Augedal AW, Hansen KS, Kronhaug CR, Harvey AG, Pallesen S. Randomized controlled trials of psychological and pharmacological treatments for nightmares: a meta-analysis. Sleep Med Rev. 2013;17(2):143–52. Available from: http://linkinghub.elsevier.com/retrieve/pii/S1087079212000718. Accessed 21 Aug 2017.

28.

Casement MD, Swanson LM. A meta-analysis of imagery rehearsal for post-trauma nightmares: effects on nightmare frequency, sleep quality, and posttraumatic stress. Clin Psychol Rev. 2012;32(6):566–74. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=4120639&tool=pmcentrez&rendertype=abstract. Accessed 12 Nov 2014.CrossRefPubMedPubMedCentral

29.

Krakow B, Zadra A. Imagery rehearsal therapy: principles and practice. Available from: http://www.sciencedirect.com/sdfe/pdf/download/eid/1-s2.0-S1556407X10000056/first-page-pdf. Accessed 7 Aug 2017.

30.

Davis JL, Wright DC. Exposure, relaxation, and rescripting treatment for trauma-related nightmares. J Trauma Dissociation. 2006;7(1):5–18. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16618692. Accessed 12 Nov 2014.CrossRefPubMed

31.

Krakow B, Hollifield M, Johnston L, Koss M, Schrader R, Warner TD, et al. Imagery rehearsal therapy for chronic nightmares in sexual assault survivors with posttraumatic stress disorder: a randomized controlled trial. JAMA. 2001;286(5):537–45. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11476655. Accessed 12 Nov 2014.CrossRefPubMed

32.

Krakow B, Johnston L, Melendrez D, Hollifield M, Warner TD, Chavez-Kennedy D, et al. An open-label trial of evidence-based cognitive behavior therapy for nightmares and insomnia in crime victims with PTSD. Am J Psychiatry. 2001;158(12):2043–7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11729023. Accessed 12 Nov 2014.CrossRefPubMed

33.

Krakow B, Hollifield M, Schrader R, Koss M, Tandberg D, Lauriello J, et al. A controlled study of imagery rehearsal for chronic nightmares in sexual assault survivors with PTSD: a preliminary report. J Trauma Stress. 2000;13(4):589–609. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11109233. Accessed 12 Nov 2014.CrossRefPubMed

34.

Forbes D, Phelps A, McHugh T. Treatment of combat-related nightmares using imagery rehearsal: a pilot study. J Trauma Stress. 2001;14(2):433–42. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11469167. Accessed 5 Nov 2014.CrossRefPubMed

35.

Lu M, Wagner A, Van Male L, Whitehead A, Boehnlein J. Imagery rehearsal therapy for posttraumatic nightmares in U.S. veterans. J Trauma Stress. 2009;22(3):236–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19444882. Accessed 12 Nov 2014.CrossRefPubMed

36.

Cook JM, Harb GC, Gehrman PR, Cary MS, Gamble GM, Forbes D, et al. Imagery rehearsal for posttraumatic nightmares: a randomized controlled trial. J Trauma Stress. 2010;23(5):553–63. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20839311. Accessed 12 Nov 2014.CrossRefPubMed

37.

van Schagen AM, Lancee J, de Groot IW, Spoormaker VI, van den Bout J. Imagery rehearsal therapy in addition to treatment as usual for patients with diverse psychiatric diagnoses suffering from nightmares: a randomized controlled trial. J Clin Psychiatry. 2015;76(9):e1105–13. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26455674. Accessed 16 Sept 2016.CrossRefPubMed

38.

Wing JK, Babor T, Brugha T, Burke J, Cooper JE, Giel R, et al. SCAN. Schedules for Clinical Assessment in Neuropsychiatry. Arch Gen Psychiatry. 1990;47(6):589–93. Available from: http://www.ncbi.nlm.nih.gov/pubmed/2190539. Accessed 7 Nov 2016.

39.

Sonne C, Carlsson J, Elklit A, Mortensen EL, Ekstrøm M. Treatment of traumatized refugees with sertraline versus venlafaxine in combination with psychotherapy – study protocol for a randomized clinical trial. Trials. 2013;14:137. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3658898&tool=pmcentrez&rendertype=abstract. Accessed 11 Sept 2014.CrossRefPubMedPubMedCentral

40.

Sonne CK. Trauma-affected refugees: pharmacological treatment and psychosocial predictors of treatment outcome PhD thesis. Available from: https://www.psykiatri-regionh.dk/centre-og-social-tilbud/kompetencecentre/transkulturelpsykiatri/CTP-Publications/Documents/Ph.d%20thesis__final_broad%20margin.pdf. Accessed 13 Sept 2016.

41.

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. 1989;28(2):193–213. Available from: http://www.ncbi.nlm.nih.gov/pubmed/2748771. Accessed 29 Aug 2014.CrossRefPubMed

42.

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. 2013;26(2):192–200. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3746481&tool=pmcentrez&rendertype=abstract. Accessed 11 Sept 2014.CrossRefPubMedPubMedCentral

43.

Krakow B. Nightmare complaints in treatment-seeking patients in clinical sleep medicine settings: diagnostic and treatment implications. Sleep. 2006;29(10):1313–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/17068985. Accessed on 25 Apr 2015.

44.

Hollifield M, Warner TD, Lian N, Krakow B, Jenkins JH, Kesler J, et al. Measuring trauma and health status in refugees: a critical review. JAMA. 2002;288(5):611–21. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12150673. Accessed 12 Sept 2014.CrossRefPubMed

45.

Mollica RF, Wyshak G, de Marneffe D, Khuon F, Lavelle J. Indochinese versions of the Hopkins Symptom Checklist-25: a screening instrument for the psychiatric care of refugees. Am J Psychiatry. 1987;144(4):497–500. Available from: http://www.ncbi.nlm.nih.gov/pubmed/3565621. Accessed 12 Sept 2014.CrossRefPubMed

46.

Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56–62.CrossRefPubMedPubMedCentral

47.

Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994;23(2):129–38. Available from: http://www.ncbi.nlm.nih.gov/pubmed/8080219. Accessed 26 Nov 2015.PubMed

48.

Atkinson TM, Rosenfeld BD, Sit L, Mendoza TR, Fruscione M, Lavene D, et al. Using confirmatory factor analysis to evaluate construct validity of the Brief Pain Inventory (BPI). J Pain Symptom Manage. 2011;41(3):558–65. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3062715&tool=pmcentrez&rendertype=abstract. Accessed 11 Dec 2015.

49.

Blom EH, Bech P, Högberg G, Larsson JO, Serlachius E. Screening for depressed mood in an adolescent psychiatric context by brief self-assessment scales—testing psychometric validity of WHO-5 and BDI-6 indices by latent trait analyses. Health Qual Life Outcomes. 2012;10:149. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3575311&tool=pmcentrez&rendertype=abstract.CrossRefPubMedPubMedCentral

50.

Arbuckle R, Frye MA, Brecher M, Paulsson B, Rajagopalan K, Palmer S, et al. The psychometric validation of the Sheehan Disability Scale (SDS) in patients with bipolar disorder. Psychiatry Res. 2009;165(1–2):163–74. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19042030. Accessed 7 Apr 2015.CrossRefPubMed

51.

Grootenboer EMV, Giltay EJ, van der Lem R, van Veen T, van der Wee NJA, Zitman FG. Reliability and validity of the Global Assessment of Functioning Scale in clinical outpatients with depressive disorders. J Eval Clin Pract. 2012;18(2):502–7.CrossRefPubMed

52.

Ustün TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, et al. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010;88(11):815–23. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2971503&tool=pmcentrez&rendertype=abstract. Accessed 7 Nov 2015.CrossRefPubMedPubMedCentral

53.

Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. The effect of flexible cognitive-behavioural therapy and medical treatment, including antidepressants on post-traumatic stress disorder and depression in traumatised refugees: pragmatic randomised controlled clinical trial. Br J Psychiatry. 2015. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26541687. Accessed 15 Jan 2016.

54.

Timmerby N, Austin SF, Ussing K, Bech P, Csillag C. Family psychoeducation for major depressive disorder—study protocol for a randomized controlled trial. Trials. 2016;17(1):427. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27577267. Accessed 7 Nov 2016.CrossRefPubMedPubMedCentral

55.

Sheehan KH, Sheehan DV. Assessing treatment effects in clinical trials with the discan metric of the Sheehan Disability Scale. Int Clin Psychopharmacol. 2008;23(2):70–83. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18301121. Accessed 7 Nov 2016.CrossRefPubMed

56.

Bech P, Kastrup M, Rafaelsen OJ. Mini-compendium of rating scales for states of anxiety depression mania schizophrenia with corresponding DSM-III syndromes. Acta Psychiatr Scand Suppl. 1986;326:1–37. Available from: http://www.ncbi.nlm.nih.gov/pubmed/3458353. Accessed 16 Oct 2015.PubMed

57.

Vindbjerg E, Klimpke C, Carlsson J. Psychotherapy with traumatised refugees—the design of a randomised clinical trial. Torture. 2014;24(1):40–8. Available from: http://irct.org/assets/uploads/Psychotherapy%20with%20traumatised%20refugees.pdf. Accessed 29 Dec 2014.PubMed

58.

Nordbrandt MS, Carlsson J, Lindberg LG, Sandahl H, Mortensen EL. Treatment of traumatised refugees with basic body awareness therapy versus mixed physical activity as add-on treatment: study protocol of a randomised controlled trial. Trials. 2015;16(1):477. Available from: http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0974-9. Accessed 7 Nov 2016.CrossRefPubMedPubMedCentral

59.

Sonne C, Carlsson J, Bech P, Elklit A, Mortensen EL. Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy—a randomised study. BMC Psychiatry. 2016;16(1):383.CrossRefPubMedPubMedCentral

60.

Søvn JP. København: Munksgaard. 1st edition. 2013. Available from: http://www.munksgaard.dk/Medicin/S%F8vn/9788762810532. Accessed 26 Apr 2015.

61.

Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011;139(6):1514–27. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3109647&tool=pmcentrez&rendertype=abstract. Accessed 26 May 2015.CrossRefPubMedPubMedCentral

62.

Stiasny-Kolster K, Mayer G, Schäfer S, Möller JC, Heinzel-Gutenbrunner M, Oertel WH. The REM sleep behavior disorder screening questionnaire—a new diagnostic instrument. Mov Disord. 2007;22(16):2386–93. Available from: http://www.ncbi.nlm.nih.gov/pubmed/17894337. Accessed 23 Oct 2015.CrossRefPubMed

63.

Levy Berg A, Sandahl C, Clinton D. The relationship of treatment preferences and experiences to outcome in generalized anxiety disorder (GAD). Psychol Psychother. 2008;81(Pt 3):247–59. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18435869. Accessed 22 Nov 2016.CrossRefPubMed

64.

Pelletier LG, Tuson KM, Haddad NK. Client Motivation for Therapy Scale: a measure of intrinsic motivation, extrinsic motivation, and amotivation for therapy. J Pers Assess. 1997;68(2):414–35. Available from: http://www.ncbi.nlm.nih.gov/pubmed/9107015. Accessed 7 Nov 2015.CrossRefPubMed

65.

Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000;55(1):68–78. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11392867. Accessed 22 Nov 2016.CrossRefPubMed

66.

Rotter JB. Generalized expectancies for internal versus external control of reinforcement. Psychol Monogr. 1966;80(1):1–28. Available from: http://www.ncbi.nlm.nih.gov/pubmed/5340840. Accessed 27 Nov 2016.CrossRefPubMed

67.

Duncan BL, Miller SD, Sparks JA, Claud DA, Reynolds LR, Brown J, et al. The Session Rating Scale: preliminary psychometric properties of a “Working” Alliance Measure. J Brief Ther. 2003;3(31):3–12.

68.

Jespersen KV, Vuust P. The Effect of relaxation music listening on sleep quality in traumatized refugees: a pilot study—ProQuest. J Music Ther. 2012;49(2):205–29. Available from: https://www.ncbi.nlm.nih.gov/pubmed/2675321810.1186/s13063-017-2260-. Accessed 10 Dec 2014.CrossRefPubMed

Title: Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial
Authors: Hinuga Sandahl
Poul Jennum
Lone Baandrup
Ida Sophie Poschmann
Jessica Carlsson
Publication date: 01-12-2017
Publisher: BioMed Central
Published in: Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-017-2260-5

At a glance: The STEP trials

Springer Medicine

Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2017

The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial

Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial

Accreditation in general practice in Denmark: study protocol for a cluster-randomized controlled trial

Addition of Propranolol in Resistant Arterial hypertension Treatment (APROPRIATE study): study protocol for a randomized double-blind placebo-controlled trial

Clinicians’ views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial