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

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

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.

Keywords: Imagery rehearsal therapy; Mianserin; Nightmare; PTSD; Post-traumatic stress disorder; Refugee; Sleep; Sleep disturbances; Trauma.

Conflict of interest statement

Authors’ information

Principal investigator: Hinuga Sandahl, Competence Centre for Transcultural Psychiatry, Mental Health Centre Ballerup in the Capital Region, Denmark, e-mail: Hinuga.sandahl.01@regionh.dk.

Sponsor: Jessica Carlsson Lohmann, Competence Centre for Transcultural Psychiatry, Mental Health Centre Ballerup in the Capital Region, Denmark, e-mail: Jessica.carlsson.lohmann@regionh.dk.

Ethics approval and consent to participate

The trial protocol and amendments have been approved by The Ethics Committee of the Capital Region of Denmark (H-15014503), the Danish Medicines Agency (EudraCT: 2015-004153-40) and the Danish Data Protection Agency (2012-58-0004) and is registered at ClinicalTrials.gov (NCT02761161). The project is conducted in accordance with the Helsinki II Declaration. The trial is monitored by the GCP (Good Clinical Practice) Unit at Copenhagen University Hospital.

Participation in the project is voluntary and requires written, informed consent. Taking part in the trial is not a prerequisite for receiving treatment at the clinic. Patients can stop treatment and leave the trial at any time.

Randomisation is considered ethical, as current evidence cannot clarify whether one of the treatments offered to the patients is better than the other.

Consent for publication

Not applicable.

Competing interests

The authors HS, PJ, LB, IP and JC hereby declare that they have no financial or other competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram for enrolment, allocation, follow-up and analysis
Fig. 2
Fig. 2
Schedule of enrolment, interventions and assessments

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