Clinical trial NCT02761161: Treatment of Sleep Disturbances in Trauma-affected Refugees
Official title: Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Traumatic Stress Disorder
Depression
Keywords: PTSD
Sleep
Refugee
IRT
Mianserin
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Center for Sleep Medicine
First posted: 2016-05-04
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep on The Pittsburgh Sleep Quality Index
timeFrame: Change from baseline after approximately 6-8 months treatment
Secondary outcomes:
measure: Nightmares on the Disturbing Dreams and Nightmare Severity Index
timeFrame: Change from baseline after approximately 6-8 months treatment
measure: Symptoms of PTSD on The Harvard Trauma Questionnaire
timeFrame: Change from baseline after approximately 6-8 months treatment
measure: Symptoms of depression and anxiety on the Hopkins Symptom Check List
timeFrame: Change from baseline after approximately 6-8 months treatment
measure: Life quality on the WHO-5
timeFrame: Change from baseline after approximately 6-8 months treatment
measure: level of functioning on the Sheehan Disability Scale
timeFrame: Change from baseline after approximately 6-8 months treatment
measure: Sleep on the REM Sleep Behavior Disorder Screening Questionnaire
timeFrame: 2 years
measure: pain on the Brief Pain Inventory short form
timeFrame: Change from baseline after approximately 6-8 months treatment
measure: Level of functioning on the Global Assessment of functioning - Symptoms
timeFrame: Change from baseline after approximately 6-8 months treatment
measure: Level of functioning on WHODAS 2.0
timeFrame: Change from baseline after approximately 6-8 months treatment
measure: Symptoms of depression and anxiety on Hamilton depression and anxiety scales
timeFrame: Change from baseline after approximately 6-8 months treatment
measure: Sleep on Actigraph
timeFrame: two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Competence Centre for Transcultural Psychiatry
state: Ballerup
Study officials:
affiliation: Competence Centre for Transcultural Psychiatry
name: Hinuga Sandahl, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandahl H, Baandrup L, Vindbjerg E, Jennum P, Carlsson J. Social zeitgebers and circadian dysrhythmia are associated with severity of symptoms of PTSD and depression in trauma-affected refugees. Eur Arch Psychiatry Clin Neurosci. 2021 Oct;271(7):1319-1329. doi: 10.1007/s00406-021-01266-8. Epub 2021 May 6.
citation: Sandahl H, Carlsson J, Sonne C, Mortensen EL, Jennum P, Baandrup L. Investigating the link between subjective sleep quality, symptoms of PTSD, and level of functioning in a sample of trauma-affected refugees. Sleep. 2021 Sep 13;44(9):zsab063. doi: 10.1093/sleep/zsab063.
citation: Sandahl H, Jennum P, Baandrup L, Poschmann IS, Carlsson J. Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial. Trials. 2017 Nov 6;18(1):520. doi: 10.1186/s13063-017-2260-5.