Treatment of Sleep Disturbances in Trauma-affected Refugees

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-06-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Post Traumatic Stress Disorder Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment as usual

TAU: medicine according to algorithm, manual-based cognitive therapy, psychoeducation

Group Type NO_INTERVENTION

No interventions assigned to this group

Mianserin

10-30 mg of mianserin af sleep enhancing

Group Type ACTIVE_COMPARATOR

Mianserin

Intervention Type DRUG

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

Imagery Rehearsal Therapy

Therapy focusing on nightmares

Group Type ACTIVE_COMPARATOR

Imagery Rehearsal Therapy

Intervention Type BEHAVIORAL

IRT is add-on treatment to treatment as usual.

mianserin and Imagery Rehearsal Therapy

Both mianserin and IRT

Group Type ACTIVE_COMPARATOR

Mianserin

Intervention Type DRUG

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

Imagery Rehearsal Therapy

Intervention Type BEHAVIORAL

IRT is add-on treatment to treatment as usual.

Interventions

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Mianserin

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

Intervention Type DRUG

Imagery Rehearsal Therapy

IRT is add-on treatment to treatment as usual.

Intervention Type BEHAVIORAL

Other Intervention Names

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IRT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No