Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT02874235
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Therapy and Treatment as Usual
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'External psychologist performs primary outcome measurement not knowing participants treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-08-16', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HTQ-R', 'timeFrame': '6 months', 'description': 'DSM IV PTSD symptoms part (first 16 items) of section 4 of HTQ. the Harvard Trauma Questionnaire is a 4 point Likert scale. Scored during an interview with an external psychologist blinded to the treatment group. Measured at baseline, post-treatment and at 6 months follow up.'}, {'measure': 'Change in PTSD-8', 'timeFrame': '6 months', 'description': 'DSM IV PTSD symptoms (8 of the first 16 items) of section 4 of HTQ. The Harvard Trauma Questionnaire is a Likert 4 point scale. PTSD is scored by the patient two times during treatment before session 4 and 12. This measure is also a part of the HTQ-R (Outcome 1)'}], 'secondaryOutcomes': [{'measure': 'Change in WHO-5', 'timeFrame': '6 months', 'description': 'WHO-5 Quality of Life Scale, self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.'}, {'measure': 'Change in RAAS', 'timeFrame': '6 months', 'description': 'Revised Adult Attachment Scale. Attachment in close relationship self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.'}, {'measure': 'Change in DSS', 'timeFrame': '6 months', 'description': 'Dissociation Symptom Scale, self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.'}, {'measure': 'Change in SDQ-20', 'timeFrame': '6 months', 'description': 'Somatoform Dissociation Questionnaire, self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.'}, {'measure': 'Change in Oxytocin', 'timeFrame': '6 months', 'description': 'Oxytocin collected in saliva. Measured at baseline, post-treatment and at 6 months follow up and. pre- and post session in the third or fourth session and second or third last session.'}, {'measure': 'Change in Beta-endorphin', 'timeFrame': '6 months', 'description': 'Beta-endorphin collected in saliva. Measured at baseline, post-treatment and at 6 months follow up and pre- and post session in the third or fourth session and second or third last session.'}, {'measure': 'Change in Substance P', 'timeFrame': '6 months', 'description': 'Substance P collected in saliva. Measured at baseline, post-treatment and at 6 months follow up and pre- and post session in the third or fourth session and second or third last session.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stress Disorders, Post-Traumatic']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Alanne, S. (2010). Music Psychotherapy with Refugee Survivors of Torture: Interpretations of Three Clinical Case Studies. Sibelius Academy.'}, {'pmid': '22116038', 'type': 'BACKGROUND', 'citation': 'Alluri V, Toiviainen P, Jaaskelainen IP, Glerean E, Sams M, Brattico E. Large-scale brain networks emerge from dynamic processing of musical timbre, key and rhythm. Neuroimage. 2012 Feb 15;59(4):3677-89. doi: 10.1016/j.neuroimage.2011.11.019. Epub 2011 Nov 12.'}, {'type': 'BACKGROUND', 'citation': 'Beck, B. D., & Mumm, H. (2015). Forskning i musikterapi - posttraumatisk stressbelastning (PTSD). Dansk Musikterapi, 12(1). Retrieved from http://vbn.aau.dk/en/publications/forskning-i-musikterapi--posttraumatisk-stressbelastning-ptsd(9a7b99e6-ce28-451e-aad3-b0dbb63fff07).html'}, {'type': 'BACKGROUND', 'citation': 'Blake, R. L., & Bishop, S. R. (1994). The Bonny Method of Guided Imagery and Music (GIM) in the Treatment of Post-Traumatic Stress Disorder (PTSD) with Adults in the Psychiatric Setting. Music Therapy Perspectives, 12(2), 125-129. http://doi.org/10.1093/mtp/12.2.125'}, {'pmid': '20153242', 'type': 'BACKGROUND', 'citation': 'Koelsch S. Towards a neural basis of music-evoked emotions. Trends Cogn Sci. 2010 Mar;14(3):131-7. doi: 10.1016/j.tics.2010.01.002. Epub 2010 Feb 10.'}, {'pmid': '22360595', 'type': 'BACKGROUND', 'citation': 'Herholz SC, Halpern AR, Zatorre RJ. Neuronal correlates of perception, imagery, and memory for familiar tunes. J Cogn Neurosci. 2012 Jun;24(6):1382-97. doi: 10.1162/jocn_a_00216. Epub 2012 Feb 23.'}, {'type': 'BACKGROUND', 'citation': 'Bruscia, K. E. (2002). Guided Imagery and Music: The Bonny Method and Beyond. Barcelona Publishers.'}, {'type': 'BACKGROUND', 'citation': 'Bonny, H. L. (2002). Music Consciousness: The Evolution of Guided Imagery and Music. (L. Summer, Ed.). Gilsum, NH: Barcelona Publishers.'}, {'type': 'BACKGROUND', 'citation': 'Körlin, D., Nybäck, H., & Goldberg, F. S. (2000). Creative arts groups in psychiatric care Development and evaluation of a therapeutic alternative. Nordic Journal of Psychiatry, 54(5), 333-340.'}, {'pmid': '24571003', 'type': 'BACKGROUND', 'citation': "Kraus N, Zatorre RJ, Strait DL. Editors' introduction to Hearing Research special issue: music: a window into the hearing brain. Hear Res. 2014 Feb;308:1. doi: 10.1016/j.heares.2013.09.013. No abstract available."}, {'type': 'BACKGROUND', 'citation': 'Maack, C. (2012). Outcomes and Processes of the Bonny Method of Guided Imagery and Music (GIM) and its Adaptations and Psychodynamic Imaginative Trauma Therapy (PITT) for Women with Complex PTSD. Aalborg University Denmark 2012. Retrieved from http://gim-therapie.de/Thesis.pdf'}, {'type': 'BACKGROUND', 'citation': 'Moe, T. (2001). Restituerende faktorer i gruppemusikterapi med psykiatriske patienter - baseret på en modifikation af Guided imagery and Music (GIM) (PhD Thesis). Aalborg University Denmark. Retrieved from http://www.wfmt.info/Musictherapyworld/modules/archive/dissertations/pdfs/TorbenM.pdf'}]}, 'descriptionModule': {'briefSummary': 'This study compares music therapy with verbal psychotherapy (treatment as usual) in an outpatient psychiatric clinic for traumatized refugees. Based on positive results from a pilot study, the randomized clinical trial has a non-inferiority design to detect whether music therapy is not less effective than verbal therapy carried out by psychologists and can serve as a complementary treatment modality (n=70).\n\nThe participants are adult Arabic, English or Danish speaking refugees suffering from posttraumatic stress disorder (PTSD). The patients are referred to outpatient treatment by their medical doctor. Data collection takes place in three locations of the clinic in Region Zealand, Denmark. The music therapy method used is Guided Imagery and Music (GIM).\n\nPrimary outcome is pre, post and 6 months follow-up measures of HTQ (Harvard Trauma Questionaire) and two measures of PTSD-8 during treatment. Secondary outcomes are pre, post and 6 months follow-up measures of Quality of Life Questionnaire (WHO-5), Dissociation Symptom Scale (DSS), Somatoform Dissociation Questionaire (SDQ-20), Revised Adult Attachment Scale (RAAS) and physiological measures (salivary oxytocin, betaendorphin and Substance P).', 'detailedDescription': 'Subjects are randomized to 16 sessions of trauma modified GIM or 16 sessions of verbal psychotherapy (standard treatment).\n\nN (70) is based on a power calculation using HTQ measures from similar refugee studies, with an estimated effect size in the range 0.6-0.8.\n\nSampling All baseline measures are scored during interview with a therapist before randomization. The primary post and follow-up measures (HTQ-R) are scored during interviews conducted by external psychologists blinded to the treatment group. The secondary post and follow-up measures are self-report questionnaires scored by the patients with the help of an educated translator who is blinded with regards to the treatment group.\n\n0.5 ml salivary samples are collected in plastic tubes and stored at -20 degrees C.\n\nThe concentration of tree hormones (oxytocin, betaendorphin, substance P) are analyzed in a multiplex solution.\n\nIntervention\n\nThe intervention is a phased trauma-oriented modification (tmGIM) of the Bonny Method of Guided Imagery and Music (GIM), where music listening and spontaneous imagery in an altered state of consciousness is used within a psychotherapeutic session to promote inner transformation and growth. The method was adapted by certain constraints:\n\nUsing only a limited selection of music with musical parameters, that fully support the trauma-oriented therapeutic goals and do not provoke flashbacks.\n\nUsing short music listening periods (2-10 minutes). Listening in an upright position. Inclusion of music from Middle-Eastern cultures. Inclusion of psychoeducation and introductory mindfulness based exercises such as mindful breathing and body awareness. Initial focus on inner resources such as positive memories, imagining a safe place and the use of the music breathing technics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic Statistical Manual of Mental Disorders (DSM-5): Posttraumatic Stress Disorder Reaction: 309.81\n* Refugee status: Inhabitant in Denmark\n* International Classification of Diseases (ICD-10): F43.1: PTSD or\n* International Classification of Diseases (ICD-10): F62.0 Enduring personality change after catastrophic experience\n* Referred from a general practitioner or other unit of psychiatry\n\nExclusion Criteria:\n\n* International Classification of Diseases (ICD-10): F20-29 Schizophrenia or schizophrenia like diagnoses\n* Active Substance Abuse\n* Major Depression in connection with psychoses or suicidal risk'}, 'identificationModule': {'nctId': 'NCT02874235', 'acronym': 'RCT-KTF', 'briefTitle': 'Music Therapy and Treatment as Usual', 'organization': {'class': 'OTHER', 'fullName': 'Psychiatric Research Unit, Region Zealand, Denmark'}, 'officialTitle': 'Music Therapy Versus Treatment as Usual: A Randomized Non-inferiority Study With Traumatized Refugees Diagnosed With PTSD', 'orgStudyIdInfo': {'id': 'SJ-529'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music therapy treatment', 'description': '35 patients receiving each 16 sessions of Receptive music therapy', 'interventionNames': ['Behavioral: Receptive music therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': '35 patients receiving each 16 sessions of Psychological treatment', 'interventionNames': ['Behavioral: Psychological treatment']}], 'interventions': [{'name': 'Receptive music therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Modified Guided Imagery and Music'], 'description': '16 sessions of a length of one hour comprising of receptive music psychotherapy with 5 - 15 minutes of music listening included', 'armGroupLabels': ['Music therapy treatment']}, {'name': 'Psychological treatment', 'type': 'BEHAVIORAL', 'description': '16 sessions of a length of one hour comprising of verbal based psychotherapy based on principles from Narrative Exposure Therapy or Cognitive Behavioral Therapies', 'armGroupLabels': ['Standard treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Torben Moe, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Unit, Region Zealand Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Psychiatric Research Unit, Region Zealand, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Det Obelske Familiefond', 'class': 'UNKNOWN'}, {'name': 'Aalborg University', 'class': 'OTHER'}, {'name': 'University of Aarhus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}