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

Primary Purpose

Post Traumatic Stress Disorder, Depression

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Mianserin
Imagery Rehearsal Therapy
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring PTSD, Sleep, Refugee, IRT, Mianserin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Competence Centre for Transcultural Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Treatment as usual

Mianserin

Imagery Rehearsal Therapy

mianserin and Imagery Rehearsal Therapy

Arm Description

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

10-30 mg of mianserin af sleep enhancing

Therapy focusing on nightmares

Both mianserin and IRT

Outcomes

Primary Outcome Measures

Sleep on The Pittsburgh Sleep Quality Index

Secondary Outcome Measures

Nightmares on the Disturbing Dreams and Nightmare Severity Index
Symptoms of PTSD on The Harvard Trauma Questionnaire
Symptoms of depression and anxiety on the Hopkins Symptom Check List
Life quality on the WHO-5
level of functioning on the Sheehan Disability Scale
Sleep on the REM Sleep Behavior Disorder Screening Questionnaire
pain on the Brief Pain Inventory short form
Level of functioning on the Global Assessment of functioning - Symptoms
Level of functioning on WHODAS 2.0
Symptoms of depression and anxiety on Hamilton depression and anxiety scales
Sleep on Actigraph

Full Information

First Posted
April 27, 2016
Last Updated
September 13, 2019
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Danish Center for Sleep Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02761161
Brief Title
Treatment of Sleep Disturbances in Trauma-affected Refugees
Acronym
PTF5
Official Title
Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Danish Center for Sleep Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. Treatment as usual (TAU); pharmacological treatment according to algorithm and manual based Cognitive Behavioural Therapy TAU and add-on treatment with mianserin TAU and add-on treatment with Imagery Rehearsal Therapy (IRT) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Depression
Keywords
PTSD, Sleep, Refugee, IRT, Mianserin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
TAU: medicine according to algorithm, manual-based cognitive therapy, psychoeducation
Arm Title
Mianserin
Arm Type
Active Comparator
Arm Description
10-30 mg of mianserin af sleep enhancing
Arm Title
Imagery Rehearsal Therapy
Arm Type
Active Comparator
Arm Description
Therapy focusing on nightmares
Arm Title
mianserin and Imagery Rehearsal Therapy
Arm Type
Active Comparator
Arm Description
Both mianserin and IRT
Intervention Type
Drug
Intervention Name(s)
Mianserin
Intervention Description
mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.
Intervention Type
Behavioral
Intervention Name(s)
Imagery Rehearsal Therapy
Other Intervention Name(s)
IRT
Intervention Description
IRT is add-on treatment to treatment as usual.
Primary Outcome Measure Information:
Title
Sleep on The Pittsburgh Sleep Quality Index
Time Frame
Change from baseline after approximately 6-8 months treatment
Secondary Outcome Measure Information:
Title
Nightmares on the Disturbing Dreams and Nightmare Severity Index
Time Frame
Change from baseline after approximately 6-8 months treatment
Title
Symptoms of PTSD on The Harvard Trauma Questionnaire
Time Frame
Change from baseline after approximately 6-8 months treatment
Title
Symptoms of depression and anxiety on the Hopkins Symptom Check List
Time Frame
Change from baseline after approximately 6-8 months treatment
Title
Life quality on the WHO-5
Time Frame
Change from baseline after approximately 6-8 months treatment
Title
level of functioning on the Sheehan Disability Scale
Time Frame
Change from baseline after approximately 6-8 months treatment
Title
Sleep on the REM Sleep Behavior Disorder Screening Questionnaire
Time Frame
2 years
Title
pain on the Brief Pain Inventory short form
Time Frame
Change from baseline after approximately 6-8 months treatment
Title
Level of functioning on the Global Assessment of functioning - Symptoms
Time Frame
Change from baseline after approximately 6-8 months treatment
Title
Level of functioning on WHODAS 2.0
Time Frame
Change from baseline after approximately 6-8 months treatment
Title
Symptoms of depression and anxiety on Hamilton depression and anxiety scales
Time Frame
Change from baseline after approximately 6-8 months treatment
Title
Sleep on Actigraph
Time Frame
two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hinuga Sandahl, MD.
Organizational Affiliation
Competence Centre for Transcultural Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Competence Centre for Transcultural Psychiatry
City
Copenhagen
State/Province
Ballerup
ZIP/Postal Code
2750
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33956223
Citation
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.
Results Reference
derived
PubMed Identifier
33710347
Citation
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.
Results Reference
derived
PubMed Identifier
29110681
Citation
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.
Results Reference
derived

Learn more about this trial

Treatment of Sleep Disturbances in Trauma-affected Refugees

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