Treatment of Sleep Disturbances in Trauma-affected Refugees

Phase 4

Completed

• Conditions: Post Traumatic Stress Disorder; Depression
• Interventions: Behavioral: Imagery Rehearsal Therapy; Drug: Mianserin

• Registration Number: NCT02761161
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-04
• Status Verified: 2017-08
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Imagery Rehearsal Therapy	Imagery Rehearsal Therapy	Therapy focusing on nightmares
mianserin and Imagery Rehearsal Therapy	Imagery Rehearsal Therapy	Both mianserin and IRT
Mianserin	Mianserin	10-30 mg of mianserin af sleep enhancing
mianserin and Imagery Rehearsal Therapy	Mianserin	Both mianserin and IRT

Primary Outcome Measures

Name	Time	Method
Sleep on The Pittsburgh Sleep Quality Index	Change from baseline after approximately 6-8 months treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Competence Centre for Transcultural Psychiatry; 🇩🇰 Copenhagen, Ballerup, Denmark