Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 1:46 PM
Study NCT ID:
NCT05894759
Status:
UNKNOWN
Last Update Posted:
2023-06-09
First Post:
2023-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Different Relaxation Techniques on Psoriasis Patients With an Elevated Psychological Stress Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dermatological Life Quality Index', 'timeFrame': '6 months', 'description': 'Dermatological Life Quality Index Score will be calculated at baseline, 1 month and 6 months.\n\nDermatological Life Quality Index minimum score = 0 (no impairment of life quality) Dermatological Life Quality Index maximum score = 30 (maximum impairment of life quality)'}, {'measure': 'Psychological stress', 'timeFrame': '6 months', 'description': 'A visual analog scale will be used at baseline, 1 month and 6 months. Analog scale minimum value = 0 (no stress) Analog scale maximum value = 10 (maximum stress)'}, {'measure': 'General Anxiety Disorder-7', 'timeFrame': '6 months', 'description': 'General Anxiety Disorder-7 questionnaire will be applied at baseline, 1 month and 6 months.\n\nGeneral anxiety disorded-7 minimum score = 0 (no anxiety) General anxiety disorded-7 maximum score = 21 (maximum anxiety)'}, {'measure': 'Patient Health Questionnaire-9', 'timeFrame': '6 months', 'description': 'Patient Health Questionnaire-9 will be applied at baseline, 1 month and 6 months.\n\nPatient Health Questionnaire-9 minimum score = 0 (no depression) Patient Health Questionnaire-9 maximum score = 27 (maximum depression)'}], 'secondaryOutcomes': [{'measure': 'Psoriasis Area and Severity Index', 'timeFrame': '6 months', 'description': 'Psoriasis Area and Severity Index score will be calculated will be applied at baseline, 1 month and 6 months.\n\nPsoriasis Area and Severity Index minimum score = 0 (no severity - no lesions) Psoriasis Area and Severity Index maximum score = 72 (maximum severity)'}, {'measure': 'Self Administered Psoriasis Area and Severity Index', 'timeFrame': '6 months', 'description': 'The self Administered Psoriasis Area and Severity Index score will be calculated by the patient at baseline, 1 month and 6 months.\n\nThe self Administered Psoriasis Area and Severity Index minimum score = 0 (no severity - no lesions) The self Administered Psoriasis Area and Severity Index maximum score = 72 (maximum severity)'}, {'measure': 'The Revised Illness Perception Questionnaire', 'timeFrame': '6 months', 'description': 'The Revised Illness Perception Questionnaire will be applied at baseline, 1 month and 6 months.\n\nThe Revised Illness Perception Questionnaire minimum score = 0 (best illness perception) The Revised Illness Perception Questionnaire maximum score = 80 (worst illness perception)'}, {'measure': 'Dermatological treatment compliance', 'timeFrame': '6 months', 'description': 'A visual analog scale will be applied at baseline, 1 month and 6 months. Analog scale minimum value = 0 (total lack of compliance) Analog scale maximum value = 10 (maximum compliance)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis', 'Stress, Psychological', 'Depression', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Two mind-relaxing techniques will be applied to psoriasis patients with an elevated psychological stress profile at baseline'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of psoriasis\n* adequate psychological stress profile\n* access to a personal computer/ laptop/ smartphone with internet connection\n* agreement to the informed consent form\n\nExclusion Criteria:\n\n* other dermatological conditions which impair the life quality\n* psychological disorders under psychiatric treatment\n* hearing impairment\n* other on-going medical studies\n* pregnancy\n* aliteracy'}, 'identificationModule': {'nctId': 'NCT05894759', 'briefTitle': 'The Impact of Different Relaxation Techniques on Psoriasis Patients With an Elevated Psychological Stress Level', 'organization': {'class': 'OTHER', 'fullName': 'Grigore T. Popa University of Medicine and Pharmacy'}, 'officialTitle': 'Psychodermatological Approaches of Psoriasis', 'orgStudyIdInfo': {'id': '293/14.04.2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music therapy', 'description': 'Patients will undergo music therapy, delivered online, for 1 month.', 'interventionNames': ['Behavioral: Psychological stress relief techniques']}, {'type': 'SHAM_COMPARATOR', 'label': 'Relaxing stories', 'description': 'Patients will listen to relaxing stories, online, for 1 month.', 'interventionNames': ['Behavioral: Psychological stress relief techniques']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Dermatological treatment as per national guidelines.'}], 'interventions': [{'name': 'Psychological stress relief techniques', 'type': 'BEHAVIORAL', 'description': 'Psychological stress relief techniques', 'armGroupLabels': ['Music therapy', 'Relaxing stories']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700111', 'city': 'Iași', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Bogdan-Marian Tarcau', 'role': 'CONTACT'}], 'facility': 'Saint Spiridon Emergency Clinical County Hospital- Dermatology department', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}], 'centralContacts': [{'name': 'Bogdan-Marian Tarcau', 'role': 'CONTACT', 'email': 'bogdan-marian.tarcau@d.umfiasi.ro', 'phone': '0749872910', 'phoneExt': '+40'}], 'overallOfficials': [{'name': 'Laura Gheuca Solovastru, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Grigore T. Popa University of Medicine and Pharmacy Iasi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grigore T. Popa University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Bogdan-Marian Tarcau', 'investigatorAffiliation': 'Grigore T. Popa University of Medicine and Pharmacy'}}}}