Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-13 @ 11:00 AM
Study NCT ID:
NCT07293806
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dance-movement Therapy in the Treatment of Adolescent Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-06', 'size': 96687, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-07T10:37', 'hasProtocol': True}, {'date': '2025-12-06', 'size': 168514, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-12-07T10:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'It is not possible to mask participants or care providers. No need for masking of investigator, since the primary outcome measures are self-reporting questionnaires'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Dance movement therapy group intervention (DMT) is compared with treatment as usual (TAU)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2025-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': 'baseline, 8 weeks, 12 weeks, 6 months', 'description': 'The self-report questionnaire to assess depressive symptoms, minimum 0 maximum 63 points, more severe depression with higher scores'}, {'measure': 'YP-Core', 'timeFrame': 'baseline, 8 weeks, 12 weeks, 6 months', 'description': 'The self- report questionnaire to measure depressive and overal symptoms in youth, minimum 0 maximum 40 points or median of scores, higher scores indicating more symptoms'}], 'secondaryOutcomes': [{'measure': 'Adolescent Depression Rating Scale (ADRS)', 'timeFrame': 'baseline, 12 weeks, 6 months', 'description': 'Clinical interview to measure depressive symptoms in youth, minimum 0 and maximum 60 points, highers scores indicating more severe depression'}, {'measure': 'Body Image assessment', 'timeFrame': 'baseline, 12 weeks, 6 months', 'description': 'Self-report questionnaire to assess body image/experience, 11 items with minimum 11 and maxomum 77 points, a qualitative scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescents', 'depression', 'therapy', 'dance', 'movement'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '32903394', 'type': 'BACKGROUND', 'citation': 'Hyvonen K, Pylvanainen P, Muotka J, Lappalainen R. The Effects of Dance Movement Therapy in the Treatment of Depression: A Multicenter, Randomized Controlled Trial in Finland. Front Psychol. 2020 Aug 12;11:1687. doi: 10.3389/fpsyg.2020.01687. eCollection 2020.'}, {'pmid': '24026850', 'type': 'BACKGROUND', 'citation': 'Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.'}, {'pmid': '13688369', 'type': 'BACKGROUND', 'citation': 'BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.'}, {'pmid': '16287635', 'type': 'BACKGROUND', 'citation': 'Jeong YJ, Hong SC, Lee MS, Park MC, Kim YK, Suh CM. Dance movement therapy improves emotional responses and modulates neurohormones in adolescents with mild depression. Int J Neurosci. 2005 Dec;115(12):1711-20. doi: 10.1080/00207450590958574.'}, {'pmid': '31130889', 'type': 'BACKGROUND', 'citation': 'Karkou V, Aithal S, Zubala A, Meekums B. Effectiveness of Dance Movement Therapy in the Treatment of Adults With Depression: A Systematic Review With Meta-Analyses. Front Psychol. 2019 May 3;10:936. doi: 10.3389/fpsyg.2019.00936. eCollection 2019.'}, {'pmid': '9204677', 'type': 'BACKGROUND', 'citation': 'Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.'}, {'pmid': '31481910', 'type': 'BACKGROUND', 'citation': 'Koch SC, Riege RFF, Tisborn K, Biondo J, Martin L, Beelmann A. Effects of Dance Movement Therapy and Dance on Health-Related Psychological Outcomes. A Meta-Analysis Update. Front Psychol. 2019 Aug 20;10:1806. doi: 10.3389/fpsyg.2019.01806. eCollection 2019.'}, {'pmid': '32539160', 'type': 'BACKGROUND', 'citation': 'Millman LSM, Terhune DB, Hunter ECM, Orgs G. Towards a neurocognitive approach to dance movement therapy for mental health: A systematic review. Clin Psychol Psychother. 2021 Jan;28(1):24-38. doi: 10.1002/cpp.2490. Epub 2020 Jul 8.'}, {'pmid': '28070942', 'type': 'BACKGROUND', 'citation': 'Radovic S, Gordon MS, Melvin GA. Should we recommend exercise to adolescents with depressive symptoms? A meta-analysis. J Paediatr Child Health. 2017 Mar;53(3):214-220. doi: 10.1111/jpc.13426. Epub 2017 Jan 10.'}, {'pmid': '23769289', 'type': 'BACKGROUND', 'citation': 'Rohricht F, Papadopoulos N, Priebe S. An exploratory randomized controlled trial of body psychotherapy for patients with chronic depression. J Affect Disord. 2013 Oct;151(1):85-91. doi: 10.1016/j.jad.2013.05.056. Epub 2013 Jun 14.'}, {'pmid': '28084134', 'type': 'BACKGROUND', 'citation': "Gergov V, Lahti J, Marttunen M, Lipsanen J, Evans C, Ranta K, Laitila A, Lindberg N. Psychometric properties of the Finnish version of the Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE) questionnaire. Nord J Psychiatry. 2017 May;71(4):250-255. doi: 10.1080/08039488.2016.1270352. Epub 2017 Jan 13."}, {'pmid': '17222346', 'type': 'BACKGROUND', 'citation': 'Revah-Levy A, Birmaher B, Gasquet I, Falissard B. The Adolescent Depression Rating Scale (ADRS): a validation study. BMC Psychiatry. 2007 Jan 12;7:2. doi: 10.1186/1471-244X-7-2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this research is to measure the effectiveness of Dance movement therapy in the treatment of adolescent depression.', 'detailedDescription': 'Research will start by recruitment of 140 patients (aged 13-17 years) from youth psychiatric outpatient clinic in Helsinki University Central hospital. They will be randomized to two groups. The intervention group will attend Dance movement therapy (DMT) for 12 weeks and the control group is getting treatment as usual (TAU). The outcome will be measured with self-report questionnaires and interviews measuring symptoms of depression and body image. Outcome measurements will be done before intervention, after intervention and 3 months after intervention has finished. The research will start in September 2022 and continue until the end of 2027. The results will be published in medical scientific journals during the year 2027\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of medium or severe depression; BDI 16 points or more. At least 4/9 symptoms of depression in K-SADS-PL interview\n\nExclusion Criteria:\n\n* Acute psychosis, psychotic depression, personality disorder, severe anorexia, substance misuse that is on a critical level'}, 'identificationModule': {'nctId': 'NCT07293806', 'acronym': 'DMT', 'briefTitle': 'Dance-movement Therapy in the Treatment of Adolescent Depression', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Study Protocol for a Randomised Controlled Trial of Dance-movement Therapy for Adolescents With Depression', 'orgStudyIdInfo': {'id': 'HUS/391/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dance movement therapy', 'description': 'A group of 5-6 patients is recieving Dance movement group therapy once a week for 12 weeks', 'interventionNames': ['Other: Dance movement therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Treatment as usual in youth psychiatric outpatient clinic'}], 'interventions': [{'name': 'Dance movement therapy', 'type': 'OTHER', 'description': 'A group therapy model for treatment of depression by dance movement therapist. Study consist of 12 therapy sessions, each session lasting 1hour 15minutes. There will be 6 patients in each group.', 'armGroupLabels': ['Dance movement therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Riikka Valjakka, MD', 'role': 'CONTACT', 'email': 'riikka.valjakka@hus.fi', 'phone': '+358405882670'}, {'name': 'Elina Santti, PhD', 'role': 'CONTACT', 'email': 'elina.santti@hus.fi', 'phone': '+35894711'}, {'name': 'Riikka Valjakka, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00099', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Riikka Valjakka, MD', 'role': 'CONTACT', 'email': 'riikka.valjakka@hus.fi', 'phone': '+358 40 588 2670'}, {'name': 'Sari Korpirinne, MD', 'role': 'CONTACT', 'email': 'sari.korpirinne@hel.fi'}, {'name': 'Riikka Valjakka, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Adolecent mental health services, Helsinki', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Riikka Valjakka, MD', 'role': 'CONTACT', 'email': 'riikka.valjakka@hus.fi', 'phone': '+358445185156'}, {'name': 'Elina Santti, PhD', 'role': 'CONTACT', 'email': 'elina.santti@hus.fi', 'phone': '+35894711'}], 'overallOfficials': [{'name': 'Mauri Marttunen, Prof emer', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Helsinki'}, {'name': 'Henna Haravuori, Docent', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Finnish Institue for Health and Welfare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual deidentified participant data will not be shared due to legal and ethical restrictions and institute policy; other documents will be available (e.g., study protocol, statistical analysis plan, etc.); data (means, distributions etc.) for meta-analyses and like will be provided, data will be available earliest 2027 and according to study's institutional permissions; for researchers in esteemed institutes, with safe digital methods."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Finnish Medical Foundation', 'class': 'NETWORK'}, {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, {'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Riikka Valjakka', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}