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

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

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

Study Overview

• Status: Completed
• Conditions: Depression; Post Traumatic Stress Disorder
• Intervention / Treatment: Drug: Mianserin; Behavioral: Imagery Rehearsal Therapy

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 Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Ballerup
    • Copenhagen, Ballerup, Denmark, 2750
      • Competence Centre for Transcultural Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: IRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sleep on The Pittsburgh Sleep Quality Index	Change from baseline after approximately 6-8 months treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Nightmares on the Disturbing Dreams and Nightmare Severity Index	Change from baseline after approximately 6-8 months treatment
Symptoms of PTSD on The Harvard Trauma Questionnaire	Change from baseline 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
Sleep on the REM Sleep Behavior Disorder Screening Questionnaire	2 years
pain on the Brief Pain Inventory short form	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
Level of functioning on WHODAS 2.0	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 Actigraph	two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: Danish Center for Sleep Medicine
• Investigators: Principal Investigator: Hinuga Sandahl, MD., Competence Centre for Transcultural Psychiatry

Publications and helpful links

General Publications

• Sandahl H, Baandrup L, Vindbjerg E, Jennum P, Carlsson J. Social zeitgebers and circadian dysrhythmia are associated with severity of symptoms of PTSD and depression in trauma-affected refugees. Eur Arch Psychiatry Clin Neurosci. 2021 Oct;271(7):1319-1329. doi: 10.1007/s00406-021-01266-8. Epub 2021 May 6.
• Sandahl H, Carlsson J, Sonne C, Mortensen EL, Jennum P, Baandrup L. Investigating the link between subjective sleep quality, symptoms of PTSD, and level of functioning in a sample of trauma-affected refugees. Sleep. 2021 Sep 13;44(9):zsab063. doi: 10.1093/sleep/zsab063.
• Sandahl H, Jennum P, Baandrup L, Poschmann IS, Carlsson J. Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial. Trials. 2017 Nov 6;18(1):520. doi: 10.1186/s13063-017-2260-5.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: PTSD; Sleep; Refugee; IRT; Mianserin
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Dyssomnias; Parasomnias; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Serotonin Antagonists; Antidepressive Agents, Second-Generation; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic alpha-Antagonists; Mianserin
• Other Study ID Numbers: PTF5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No