Skip to main content
OpenTrials
Completed

NCT Number: NCT02761161

Treatment of Sleep Disturbances in Trauma-affected Refugees

The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Competence Centre for Transcultural Psychiatry

Copenhagen, Ballerup, 2750, Denmark

About this study

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.

  • Treatment as usual (TAU); pharmacological treatment according to algorithm and manual based Cognitive Behavioural Therapy
  • TAU and add-on treatment with mianserin
  • TAU and add-on treatment with Imagery Rehearsal Therapy (IRT)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mianserin

Drug

mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.

Imagery Rehearsal Therapy

Behavioral

IRT is add-on treatment to treatment as usual.

Other names: IRT

Primary outcomes

  1. Sleep on The Pittsburgh Sleep Quality Index

    Time frame: Change from baseline after approximately 6-8 months treatment

Secondary outcomes

  1. Nightmares on the Disturbing Dreams and Nightmare Severity Index

    Time frame: Change from baseline after approximately 6-8 months treatment

  2. Symptoms of PTSD on The Harvard Trauma Questionnaire

    Time frame: Change from baseline after approximately 6-8 months treatment

  3. Symptoms of depression and anxiety on the Hopkins Symptom Check List

    Time frame: Change from baseline after approximately 6-8 months treatment

  4. Life quality on the WHO-5

    Time frame: Change from baseline after approximately 6-8 months treatment

  5. level of functioning on the Sheehan Disability Scale

    Time frame: Change from baseline after approximately 6-8 months treatment

  6. Sleep on the REM Sleep Behavior Disorder Screening Questionnaire

    Time frame: 2 years

  7. pain on the Brief Pain Inventory short form

    Time frame: Change from baseline after approximately 6-8 months treatment

  8. Level of functioning on the Global Assessment of functioning - Symptoms

    Time frame: Change from baseline after approximately 6-8 months treatment

  9. Level of functioning on WHODAS 2.0

    Time frame: Change from baseline after approximately 6-8 months treatment

  10. Symptoms of depression and anxiety on Hamilton depression and anxiety scales

    Time frame: Change from baseline after approximately 6-8 months treatment

  11. Sleep on Actigraph

    Time frame: two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Danish Center for Sleep Medicine

Registry information

Official study title

Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial

Acronym: PTF5

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 4, 2016
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.