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

Mental Health Services in the Capital Region, Denmark

Status and phase: Completed; Phase 4

Conditions: Post Traumatic Stress Disorder; Depression

Treatments: Behavioral: Imagery Rehearsal Therapy; Drug: Mianserin

Study type: Interventional

Funder types: Other

Identifiers

NCT02761161

PTF5

Details and patient eligibility

About

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

Full 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.

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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241 participants in 4 patient groups

Treatment as usual

No Intervention group

Description:

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

Mianserin

Active Comparator group

Description:

10-30 mg of mianserin af sleep enhancing

Treatment:

Drug: Mianserin

Imagery Rehearsal Therapy

Active Comparator group

Description:

Therapy focusing on nightmares

Treatment:

Behavioral: Imagery Rehearsal Therapy

mianserin and Imagery Rehearsal Therapy

Active Comparator group

Description:

Both mianserin and IRT

Treatment:

Drug: Mianserin

Behavioral: Imagery Rehearsal Therapy