Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 3:43 AM
Study NCT ID:
NCT06919133
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-16
First Post:
2025-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Digital Markers in the Self-management of Depressive Symptoms
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 660}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire 9 items (PHQ-9)', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Differences between the intervention group and the control group in the total Patient Health Questionnaire 9 items (PHQ-9) score performed every 14th day during the 12-months trial period.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'From enrollmetn to end of treatment af 12 months', 'description': 'Differences between the intervention group and the control group in the level of quality of life according to the WHO Quality of life BREF16 (WHO QoL)'}, {'measure': 'Generalized Anxiety Disorder 7 items scale (GAD-7)', 'timeFrame': 'From enrollment to end of treatment at 12 months', 'description': 'Differences between the intervention group and the control group in the level of anxiety symptoms according to the Generalized Anxiety Disorder scale (GAD-7)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Mental distress', 'Smartphone', 'Trial', 'self-management'], 'conditions': ['Depression - Major Depressive Disorder', 'Mental Distress']}, 'descriptionModule': {'briefSummary': "The purpose of the MENTINA trial is to investigate the effect of using the smartphone-based MENTINA app for self-monitoring of depressive symptoms and rule-based feedback in individuals with current or previous depression, psychological vulnerability, and increased risk of depression in a randomized controlled trial (RCT) over a 12-month trial period. The aim is to potentially offer the MENTINA app as a self-management tool for individuals with psychological vulnerability and/or depressive symptoms or episodes.\n\nMethod and Design:\n\nInternational, multicenter (three centers), parallel-group, RCT. The active group is assigned the smartphone-based MENTINA app including rule-based data feedback. The control group uses the MENTINA app for questionnaire-based data collection (outcomes) and collection of sensor-based data.\n\nStudy Procedures:\n\nThe trial will be open-label and unblinded. The trial uses the self-reported Patient Health Questionnaire-9 score (PHQ-9) as the primary outcome measure. Scoring will take place every 14 days over the 12-month trial period. Depressive symptoms during the first 6 months of app use will also be evaluated as secondary outcomes.\n\nParticipants, Including Inclusion and Exclusion Criteria A total of 220 individuals will be included from each center (Denmark, Germany, and Spain) with psychological vulnerability (depressive symptoms and possibly previous depressive episodes). A total sample size of 660 participants will be included.\n\nInclusion criteria:\n\n* Age 18 years or older\n* Depressive symptoms, assessed by PHQ-9 \\> 8, AND/OR\n* Current or previous depressive episode(s) (ICD-10 F32, F33)\n* Owns and uses a smartphone\n* Signed informed consent to participate\n\nExclusion criteria:\n\n* ICD-10 diagnosis of dementia, schizophrenia, mania, or bipolar disorder, as well as ongoing substance abuse\n* Current psychotic depression\n* Current suicide risk\n* Acute somatic illness requiring treatment (intensive care)\n* Insufficient language skills in Danish, German or Spanish (depending on site)\n\nSide Effects, Risks, and Disadvantages\n\nSide effects and risks:\n\nWe do not expect any serious side effects from using the MENTINA app. Possible side effects could include increased focus on one's own illness, potentially worsening depressive symptoms and suicidal thoughts.\n\nRecruitment of Participants The study population will consist of adults vulnerable to mental health issues, defined by a PHQ-9 score \\> 8 or previous depressive symptoms at the time of inclusion. Each study site will be responsible for local recruitment and follow-up.", 'detailedDescription': 'The intervention in the MENTINA trial consist of a smartphone app, which allows for daily monitoirng of symptoms such as mood, sleep, activity etc. Also, a library with content concerning depressive symptoms will be available.\n\nRules for feedback based of self-reported measures will be developed. Based on the self-reported measures participants will be suggested to read items from the library or call emergency health care facilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Depressive symptoms, assessed by PHQ-9 \\> 8, AND/OR\n* Current or previous depressive episode(s) (ICD-10 F32, F33)\n* Owns and uses a smartphone\n* Signed informed consent to participate\n\nExclusion Criteria:\n\n* ICD-10 diagnosis of dementia, schizophrenia, mania, or bipolar disorder, as well as ongoing substance abuse\n* Current psychotic depression\n* Current suicide risk\n* Acute somatic illness requiring treatment (intensive care)\n* Insufficient language skills in Danish, German or Spanish and english (depending on site)'}, 'identificationModule': {'nctId': 'NCT06919133', 'acronym': 'MENTINA', 'briefTitle': 'The Effect of Digital Markers in the Self-management of Depressive Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Mental Health Services in the Capital Region, Denmark'}, 'officialTitle': 'The Effect of Digital Markers in the Self-management of Depressive Symptoms - The MENTINA Randomized Controlled Parallel Group Trial', 'orgStudyIdInfo': {'id': '101080651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smartphone-based self-monitoring and rule-based feedback', 'description': 'The smartphone-based MENTINA app for daily self-monitoring of depressive symptoms and other symptoms + rule-based feedback based on self-monitoried data and sensor data from smartphones', 'interventionNames': ['Device: The MENTINA app']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The app is installed for outcome measures, but no access to the content of the app is provided.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'The MENTINA app', 'type': 'DEVICE', 'description': 'A smartphone-based app is developed and used in this trial. The smartphone-based MENTINA app allows for daily self-monitoring of depressive symptoms such as mood, sleep, activity etc and rule-based feedback based on self-monitored data as well as collected sensor data. Libary with relevant content will also be available and incoorporated in the rule-based feedback.', 'armGroupLabels': ['Smartphone-based self-monitoring and rule-based feedback']}, {'name': 'Control', 'type': 'OTHER', 'description': 'The MENTINA app is installed but no content and self-monitoring is available. No rule-based feedback. Only outcome measures can be done.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Psychiatric Center Copenhagen', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sensitive data that cannot be anonymised completely.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mental Health Services in the Capital Region, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital del Mar Research Institute (IMIM)', 'class': 'OTHER'}, {'name': 'Research Centre of the German Foundation for Depression and Suicide Prevention', 'class': 'UNKNOWN'}, {'name': 'Monsenso', 'class': 'INDUSTRY'}, {'name': 'Monsenso A/S as sponsor', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, Dr.Med.', 'investigatorFullName': 'Lars Vedel Kessing', 'investigatorAffiliation': 'Mental Health Services in the Capital Region, Denmark'}}}}