Treatment of Sleep Disturbances in Trauma-affected Refugees

Depression Clinical Trial

— PTF5  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761161
• Other study ID #: PTF5
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2017
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Dyssomnias
• Parasomnias
• Post Traumatic Stress Disorder
• Sleep Wake Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Denmark	Competence Centre for Transcultural Psychiatry	Copenhagen	Ballerup

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Danish Center for Sleep Medicine

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep on The Pittsburgh Sleep Quality Index		Change from baseline after approximately 6-8 months treatment
Secondary	Nightmares on the Disturbing Dreams and Nightmare Severity Index		Change from baseline after approximately 6-8 months treatment
Secondary	Symptoms of PTSD on The Harvard Trauma Questionnaire		Change from baseline after approximately 6-8 months treatment
Secondary	Symptoms of depression and anxiety on the Hopkins Symptom Check List		Change from baseline after approximately 6-8 months treatment
Secondary	Life quality on the WHO-5		Change from baseline after approximately 6-8 months treatment
Secondary	level of functioning on the Sheehan Disability Scale		Change from baseline after approximately 6-8 months treatment
Secondary	Sleep on the REM Sleep Behavior Disorder Screening Questionnaire		2 years
Secondary	pain on the Brief Pain Inventory short form		Change from baseline after approximately 6-8 months treatment
Secondary	Level of functioning on the Global Assessment of functioning - Symptoms		Change from baseline after approximately 6-8 months treatment
Secondary	Level of functioning on WHODAS 2.0		Change from baseline after approximately 6-8 months treatment
Secondary	Symptoms of depression and anxiety on Hamilton depression and anxiety scales		Change from baseline after approximately 6-8 months treatment
Secondary	Sleep on Actigraph		two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment