Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2026-02-27 @ 7:07 PM
Study NCT ID:
NCT02761161
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2016-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Sleep Disturbances in Trauma-affected Refugees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-10-15', 'releaseDate': '2021-09-20'}, {'resetDate': '2022-03-02', 'releaseDate': '2021-12-13'}, {'resetDate': '2023-03-08', 'releaseDate': '2022-05-30'}], 'estimatedResultsFirstSubmitDate': '2021-09-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008803', 'term': 'Mianserin'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-13', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-05-02', 'lastUpdatePostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep on The Pittsburgh Sleep Quality Index', 'timeFrame': 'Change from baseline after approximately 6-8 months treatment'}], 'secondaryOutcomes': [{'measure': 'Nightmares on the Disturbing Dreams and Nightmare Severity Index', 'timeFrame': 'Change from baseline after approximately 6-8 months treatment'}, {'measure': 'Symptoms of PTSD on The Harvard Trauma Questionnaire', 'timeFrame': 'Change from baseline after approximately 6-8 months treatment'}, {'measure': 'Symptoms of depression and anxiety on the Hopkins Symptom Check List', 'timeFrame': 'Change from baseline after approximately 6-8 months treatment'}, {'measure': 'Life quality on the WHO-5', 'timeFrame': 'Change from baseline after approximately 6-8 months treatment'}, {'measure': 'level of functioning on the Sheehan Disability Scale', 'timeFrame': 'Change from baseline after approximately 6-8 months treatment'}, {'measure': 'Sleep on the REM Sleep Behavior Disorder Screening Questionnaire', 'timeFrame': '2 years'}, {'measure': 'pain on the Brief Pain Inventory short form', 'timeFrame': 'Change from baseline after approximately 6-8 months treatment'}, {'measure': 'Level of functioning on the Global Assessment of functioning - Symptoms', 'timeFrame': 'Change from baseline after approximately 6-8 months treatment'}, {'measure': 'Level of functioning on WHODAS 2.0', 'timeFrame': 'Change from baseline after approximately 6-8 months treatment'}, {'measure': 'Symptoms of depression and anxiety on Hamilton depression and anxiety scales', 'timeFrame': 'Change from baseline after approximately 6-8 months treatment'}, {'measure': 'Sleep on Actigraph', 'timeFrame': 'two weeks recording at baseline and two weeks recording after approximately 6-8 months treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PTSD', 'Sleep', 'Refugee', 'IRT', 'Mianserin'], 'conditions': ['Post Traumatic Stress Disorder', 'Depression']}, 'referencesModule': {'references': [{'pmid': '41004514', 'type': 'DERIVED', 'citation': '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': '40217415', 'type': 'DERIVED', 'citation': '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': '39773112', 'type': 'DERIVED', 'citation': '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': '33956223', 'type': 'DERIVED', '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.'}, {'pmid': '33710347', 'type': 'DERIVED', '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.'}, {'pmid': '29110681', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.', 'detailedDescription': 'BACKGROUND:\n\nSleep 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.\n\nIn 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.\n\nThe aim of this study is to examine sleep enhancing treatment in refugees with PTSD.\n\nMATERIALS AND METHOD:\n\nThe study will include 230 refugees, diagnosed with PTSD, referred to CTP. Patients who give informed consent will be randomised to four treatment groups.\n\n1. Treatment as usual (TAU); pharmacological treatment according to algorithm and manual based Cognitive Behavioural Therapy\n2. TAU and add-on treatment with mianserin\n3. TAU and add-on treatment with Imagery Rehearsal Therapy (IRT)\n4. TAU and add-on treatment with mianserin and IRT\n\nRESULTS:\n\nThis study is expected to bring forward new knowledge on both medical and therapeutic treatment of sleep disturbances in trauma-affected refugees.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years or older)\n* Refugees or persons who have been family reunified with a refugee\n* PTSD pursuant to the International Classification of Diseases ICD-10 research criteria\n* 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.\n* Sleep disturbances/ PSQI \\>8\n* Nightmares/ HTQ score on nightmare item ≥ "a little"\n* Signed informed consent\n\nExclusion Criteria:\n\n* 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\n* Current abuse of drugs or alcohol (F1x.24-F1x.26)\n* Known neurodegenerative disorder (Alzheimer\'s disease (AD), Parkinson\'s disease (PD), Levy-Body dementia (LBD))\n* In need of admission to psychiatric hospital\n* Pregnant and breastfeeding women and women of the reproductive age who wish to conceive during the project period.\n* Allergy towards active ingredients or excipients in mianserin\n* Lack of informed consent'}, 'identificationModule': {'nctId': 'NCT02761161', 'acronym': 'PTF5', 'briefTitle': 'Treatment of Sleep Disturbances in Trauma-affected Refugees', 'organization': {'class': 'OTHER', 'fullName': 'Mental Health Services in the Capital Region, Denmark'}, 'officialTitle': 'Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'PTF5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'TAU: medicine according to algorithm, manual-based cognitive therapy, psychoeducation'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mianserin', 'description': '10-30 mg of mianserin af sleep enhancing', 'interventionNames': ['Drug: Mianserin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Imagery Rehearsal Therapy', 'description': 'Therapy focusing on nightmares', 'interventionNames': ['Behavioral: Imagery Rehearsal Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mianserin and Imagery Rehearsal Therapy', 'description': 'Both mianserin and IRT', 'interventionNames': ['Drug: Mianserin', 'Behavioral: Imagery Rehearsal Therapy']}], 'interventions': [{'name': 'Mianserin', 'type': 'DRUG', 'description': 'mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.', 'armGroupLabels': ['Mianserin', 'mianserin and Imagery Rehearsal Therapy']}, {'name': 'Imagery Rehearsal Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['IRT'], 'description': 'IRT is add-on treatment to treatment as usual.', 'armGroupLabels': ['Imagery Rehearsal Therapy', 'mianserin and Imagery Rehearsal Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2750', 'city': 'Copenhagen', 'state': 'Ballerup', 'country': 'Denmark', 'facility': 'Competence Centre for Transcultural Psychiatry', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Hinuga Sandahl, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Competence Centre for Transcultural Psychiatry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mental Health Services in the Capital Region, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Center for Sleep Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-09-20', 'type': 'RELEASE'}, {'date': '2021-10-15', 'type': 'RESET'}, {'date': '2021-12-13', 'type': 'RELEASE'}, {'date': '2022-03-02', 'type': 'RESET'}, {'date': '2022-05-30', 'type': 'RELEASE'}, {'date': '2023-03-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mental Health Services in the Capital Region, Denmark'}}}}