Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT02365220
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
2015-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartphone Application, Mood and Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008137', 'term': 'Longitudinal Studies'}], 'ancestors': [{'id': 'D015331', 'term': 'Cohort Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-30', 'studyFirstSubmitDate': '2015-02-03', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Efficacy expectancy (Assessed via Credibility Expectancy Questionnaire)', 'timeFrame': 'Post-training, training day 1, 7, 14, 20', 'description': 'Assessed via Credibility Expectancy Questionnaire'}, {'measure': 'Feedback on adverse events during the daily training session (Number of subjects reporting an adverse event)', 'timeFrame': 'Post-training, last training day (day 20)', 'description': 'Number of subjects reporting an adverse event'}], 'primaryOutcomes': [{'measure': 'Change in mood (Assessed via Multidimensional Mood State Questionnaire)', 'timeFrame': 'Pre- and post-training, during 20 days of training', 'description': 'Assessed via Multidimensional Mood State Questionnaire'}, {'measure': 'Change in perceived stress', 'timeFrame': 'Pre- and post-training, during 20 days of training', 'description': 'Assessed via State-Trait-Anxiety Inventory; Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'Emotional state (Assessed via Self-Assessment-Manikin scales)', 'timeFrame': 'Post-training, during 20 days of training', 'description': 'Assessed via Self-Assessment-Manikin scales after exposition to affective pictures taken from International Affective Picture System'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smartphone Application', 'Placebo Effect', 'Mood', 'Stress']}, 'referencesModule': {'references': [{'pmid': '33594991', 'type': 'DERIVED', 'citation': 'Stalujanis E, Neufeld J, Glaus Stalder M, Belardi A, Tegethoff M, Meinlschmidt G. Induction of Efficacy Expectancies in an Ambulatory Smartphone-Based Digital Placebo Mental Health Intervention: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 17;9(2):e20329. doi: 10.2196/20329.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color.', 'detailedDescription': 'The overall goal of the outlined study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color. During 14 days, subjects will participate in regular daily training sessions. During another 6 days, subjects will transfer the smartphone-based training to daily life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Access to smartphone during study period\n\nExclusion Criteria:\n\n* Severe visual impairment\n* Dyschromatopsia\n* Severe defective hearing\n* Regular intake of medication (excl. contraceptives)\n* Severe mental disorders'}, 'identificationModule': {'nctId': 'NCT02365220', 'briefTitle': 'Smartphone Application, Mood and Stress', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Smartphone Application, Mood and Stress', 'orgStudyIdInfo': {'id': 'UNIBAS-MMH-SMA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No expectancy (control)', 'description': 'No expectancy instruction with regard to the efficacy of the daily smartphone-based training', 'interventionNames': ['Behavioral: No expectancy (control)']}, {'type': 'EXPERIMENTAL', 'label': 'Prospective expectancy', 'description': 'Prospective expectancy instruction ("Training will have an effect on...") with regard to the efficacy of the daily smartphone-based training', 'interventionNames': ['Behavioral: Prospective expectancy']}, {'type': 'EXPERIMENTAL', 'label': 'Retrospective expectancy', 'description': 'Retrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training', 'interventionNames': ['Behavioral: Retrospective expectancy']}, {'type': 'EXPERIMENTAL', 'label': 'Prospective and retrospective expectancy', 'description': 'Prospective ("Training will have an effect on...") and retrospective ("Training already had an effect on...") expectancy instruction with regard to the efficacy of the daily smartphone-based training', 'interventionNames': ['Behavioral: Prospective and retrospective expectancy']}], 'interventions': [{'name': 'No expectancy (control)', 'type': 'BEHAVIORAL', 'description': 'No expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)', 'armGroupLabels': ['No expectancy (control)']}, {'name': 'Prospective expectancy', 'type': 'BEHAVIORAL', 'description': 'Prospective expectancy instruction ("Training will have an effect on...") with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)', 'armGroupLabels': ['Prospective expectancy']}, {'name': 'Retrospective expectancy', 'type': 'BEHAVIORAL', 'description': 'Retrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)', 'armGroupLabels': ['Retrospective expectancy']}, {'name': 'Prospective and retrospective expectancy', 'type': 'BEHAVIORAL', 'description': 'Prospective ("Training will have an effect on...") and retrospective ("Training already had an effect on...") expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)', 'armGroupLabels': ['Prospective and retrospective expectancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4055', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Gunther Meinlschmidt, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Basel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}