Post Traumatic Stress DisorderPhase 4PTF5NCT02761161
Treatment of Sleep Disturbances in Trauma-affected Refugees
A Phase 4 study testing Mianserin and Imagery Rehearsal Therapy in people with Post Traumatic Stress Disorder and Depression, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Depression
- What is being tested?
- Mianserin and Imagery Rehearsal Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2016to 1 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Competence Centre for Transcultural Psychiatry
Copenhagen, Ballerup, 2750
About this study
Official title: 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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder, Depression
- Being tested
- Mianserin, Imagery Rehearsal Therapy
- Keywords
- PTSD, Sleep, Refugee, IRT, Mianserin
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MianserinDrug
mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.
Imagery Rehearsal TherapyBehavioural
Also called IRT
IRT is add-on treatment to treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | TAU: medicine according to algorithm, manual-based cognitive therapy, psychoeducation |
| Mianserin | Active comparator | 10-30 mg of mianserin af sleep enhancing Receives: Drug: Mianserin |
| Imagery Rehearsal Therapy | Active comparator | Therapy focusing on nightmares Receives: Behavioral: Imagery Rehearsal Therapy |
| mianserin and Imagery Rehearsal Therapy | Active comparator | Both mianserin and IRT Receives: Drug: Mianserin; Behavioral: Imagery Rehearsal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep on The Pittsburgh Sleep Quality Index
Measured: Change from baseline after approximately 6-8 months treatment
Secondary outcomes (11)
Nightmares on the Disturbing Dreams and Nightmare Severity Index
Measured: Change from baseline after approximately 6-8 months treatment
Symptoms of PTSD on The Harvard Trauma Questionnaire
Measured: Change from baseline after approximately 6-8 months treatment
Symptoms of depression and anxiety on the Hopkins Symptom Check List
Measured: Change from baseline after approximately 6-8 months treatment
Life quality on the WHO-5
Measured: Change from baseline after approximately 6-8 months treatment
level of functioning on the Sheehan Disability Scale
Measured: Change from baseline after approximately 6-8 months treatment
Sleep on the REM Sleep Behavior Disorder Screening Questionnaire
Measured: 2 years
pain on the Brief Pain Inventory short form
Measured: Change from baseline after approximately 6-8 months treatment
Level of functioning on the Global Assessment of functioning - Symptoms
Measured: Change from baseline after approximately 6-8 months treatment
Level of functioning on WHODAS 2.0
Measured: Change from baseline after approximately 6-8 months treatment
Symptoms of depression and anxiety on Hamilton depression and anxiety scales
Measured: Change from baseline after approximately 6-8 months treatment
Sleep on Actigraph
Measured: two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMar 2016
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Center for Sleep Medicine
- Responsible party
- Sponsor
- Investigators
- Hinuga Sandahl, MD., Principal investigator, Competence Centre for Transcultural Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761161
- Sponsor's protocol ID
- PTF5
- Acronym
- PTF5
- Status last verified
- Aug 2017
- First submitted
- 27 Apr 2016
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Carlsson J, Bruhn M, Poschmann IS, Silove D, Westergaard ML, Mortensen EL, Sandahl H. Identifying robust predictors of treatment response in trauma-affected refugees: Results from a randomised controlled trial. PLoS One. 2025 Sep 26;20(9):e0324935. doi: 10.1371/journal.pone.0324935. eCollection 2025.
PubMed 41004514Sandahl H, Korshoj M, Mortensen OS, Carlsson J. Increase in physical activity is associated with an increase in sleep efficiency, but not with improvement in symptoms of PTSD: analysis of longitudinal data in trauma-affected refugees. J Act Sedentary Sleep Behav. 2024 Feb 15;3(1):7. doi: 10.1186/s44167-024-00046-8.
PubMed 40217415Asah C, Sandahl H, Baandrup L, Carlsson J, Jennum P. Dream Enactment Behaviour in Post-Traumatic Stress Disorder. Eur J Psychotraumatol. 2025 Dec;16(1):2444743. doi: 10.1080/20008066.2024.2444743. Epub 2025 Jan 7.
PubMed 39773112Sandahl 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.
PubMed 33956223Sandahl 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.
PubMed 33710347Sandahl 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.
PubMed 29110681
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02761161
- Acronym / sponsor ID
- PTF5 / PTF5
- Conditions
- Post Traumatic Stress Disorder, Depression
- Keywords
- PTSD, Sleep, Refugee, IRT, Mianserin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Danish Center for Sleep Medicine
- Study start
- Mar 2016
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –TAU: medicine according to algorithm, manual-based cognitive therapy, psychoeducation |
| Mianserin | Active comparator | Drug: Mianserin10-30 mg of mianserin af sleep enhancing |
| Imagery Rehearsal Therapy | Active comparator | Behavioral: Imagery Rehearsal TherapyTherapy focusing on nightmares |
| mianserin and Imagery Rehearsal Therapy | Active comparator | Drug: Mianserin, Behavioral: Imagery Rehearsal TherapyBoth mianserin and IRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mianserinmianserin is add-on treatment to treatment as usual. Max dose 30 mg day. | Drug | Mianserin, mianserin and Imagery Rehearsal Therapy |
| Imagery Rehearsal TherapyAlso: IRTIRT is add-on treatment to treatment as usual. | Behavioural | Imagery Rehearsal Therapy, mianserin and Imagery Rehearsal Therapy |
Primary outcome
Sleep on The Pittsburgh Sleep Quality Index
Time frame: Change from baseline after approximately 6-8 months treatment
11 secondary outcomes
Nightmares on the Disturbing Dreams and Nightmare Severity Index
Time frame: Change from baseline after approximately 6-8 months treatment
Symptoms of PTSD on The Harvard Trauma Questionnaire
Time frame: Change from baseline after approximately 6-8 months treatment
Symptoms of depression and anxiety on the Hopkins Symptom Check List
Time frame: Change from baseline after approximately 6-8 months treatment
Life quality on the WHO-5
Time frame: Change from baseline after approximately 6-8 months treatment
level of functioning on the Sheehan Disability Scale
Time frame: Change from baseline after approximately 6-8 months treatment
Sleep on the REM Sleep Behavior Disorder Screening Questionnaire
Time frame: 2 years
pain on the Brief Pain Inventory short form
Time frame: Change from baseline after approximately 6-8 months treatment
Level of functioning on the Global Assessment of functioning - Symptoms
Time frame: Change from baseline after approximately 6-8 months treatment
Level of functioning on WHODAS 2.0
Time frame: Change from baseline after approximately 6-8 months treatment
Symptoms of depression and anxiety on Hamilton depression and anxiety scales
Time frame: Change from baseline after approximately 6-8 months treatment
Sleep on Actigraph
Time frame: two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Derived from this study: PubMed 41004514Carlsson J, Bruhn M, Poschmann IS, Silove D, Westergaard ML, Mortensen EL, Sandahl H. Identifying robust predictors of treatment response in trauma-affected refugees: Results from a randomised controlled trial. PLoS One. 2025 Sep 26;20(9):e0324935. doi: 10.1371/journal.pone.0324935. eCollection 2025.
- Derived from this study: PubMed 40217415Sandahl H, Korshoj M, Mortensen OS, Carlsson J. Increase in physical activity is associated with an increase in sleep efficiency, but not with improvement in symptoms of PTSD: analysis of longitudinal data in trauma-affected refugees. J Act Sedentary Sleep Behav. 2024 Feb 15;3(1):7. doi: 10.1186/s44167-024-00046-8.
- Derived from this study: PubMed 39773112Asah C, Sandahl H, Baandrup L, Carlsson J, Jennum P. Dream Enactment Behaviour in Post-Traumatic Stress Disorder. Eur J Psychotraumatol. 2025 Dec;16(1):2444743. doi: 10.1080/20008066.2024.2444743. Epub 2025 Jan 7.
- Derived from this study: PubMed 33956223Sandahl 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.
- Derived from this study: PubMed 33710347Sandahl 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.
- Derived from this study: PubMed 29110681Sandahl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hinuga Sandahl, MD. principal investigator
Competence Centre for Transcultural Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mianserin and Imagery Rehearsal Therapy in people with Post Traumatic Stress Disorder and Depression, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep on The Pittsburgh Sleep Quality Index (time frame: Change from baseline after approximately 6-8 months treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761161, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.