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Treatment of Sleep Disturbances in Trauma-affected Refugees (PTF5)

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ClinicalTrials.gov Identifier: NCT02761161
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Danish Center for Sleep Medicine
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

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

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Depression Drug: Mianserin Behavioral: Imagery Rehearsal Therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial
Study Start Date : March 2016
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Treatment as usual
TAU: medicine according to algorithm, manual-based cognitive therapy, psychoeducation
Active Comparator: Mianserin
10-30 mg of mianserin af sleep enhancing
Drug: Mianserin
mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.

Active Comparator: Imagery Rehearsal Therapy
Therapy focusing on nightmares
Behavioral: Imagery Rehearsal Therapy
IRT is add-on treatment to treatment as usual.
Other Name: IRT

Active Comparator: mianserin and Imagery Rehearsal Therapy
Both mianserin and IRT
Drug: Mianserin
mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.

Behavioral: Imagery Rehearsal Therapy
IRT is add-on treatment to treatment as usual.
Other Name: IRT




Primary Outcome Measures :
  1. Sleep on The Pittsburgh Sleep Quality Index [ Time Frame: Change from baseline after approximately 6-8 months treatment ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761161


Locations
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Denmark
Competence Centre for Transcultural Psychiatry
Copenhagen, Ballerup, Denmark, 2750
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Danish Center for Sleep Medicine
Investigators
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Principal Investigator: Hinuga Sandahl, MD. Competence Centre for Transcultural Psychiatry
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT02761161    
Other Study ID Numbers: PTF5
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mental Health Services in the Capital Region, Denmark:
PTSD
Sleep
Refugee
IRT
Mianserin
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Sleep Wake Disorders
Nervous System Diseases
Mianserin
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs