Treatment of Sleep Disturbances in Trauma-affected Refugees

NCT02761161 | Completed Phase 4 DMC

• 1 other identifier: PTF5
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Traumatic Stress Disorder; Depression

Keywords

PTSD; Sleep; Refugee; IRT; Mianserin

Outcome Measures

Primary Outcomes (1)

• Sleep on The Pittsburgh Sleep Quality Index

  Change from baseline after approximately 6-8 months treatment

Secondary Outcomes (11)

• 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

Study Arms (4)

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

Drug: Mianserin

Imagery Rehearsal Therapy

ACTIVE COMPARATOR

Therapy focusing on nightmares

Behavioral: Imagery Rehearsal Therapy

mianserin and Imagery Rehearsal Therapy

ACTIVE COMPARATOR

Both mianserin and IRT

Drug: Mianserin; Behavioral: Imagery Rehearsal Therapy

Interventions

Mianserin DRUG

mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.

Mianserin; mianserin and Imagery Rehearsal Therapy

Imagery Rehearsal Therapy BEHAVIORAL

IRT is add-on treatment to treatment as usual.

Also known as: IRT

Imagery Rehearsal Therapy; mianserin and Imagery Rehearsal Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Danish Center for Sleep Medicine: collaborator

Study Sites (1)

Competence Centre for Transcultural Psychiatry

Copenhagen, Ballerup, 2750, Denmark

Location

Related Publications (6)

• 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.

  PMID: 41004514 DERIVED

• Sandahl 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.

  PMID: 40217415 DERIVED

• Asah 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.

  PMID: 39773112 DERIVED

• 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.

  PMID: 33956223 DERIVED

• 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.

  PMID: 33710347 DERIVED

• 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.

  PMID: 29110681 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Mianserin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hinuga Sandahl, MD.

  Competence Centre for Transcultural Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 4, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 16, 2019

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)