Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 6:11 AM
Study NCT ID:
NCT05211960
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2022-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All participants will be recruited knowing that a mindfulness app will be provided.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WHO Disability Assessment Schedule (WHODAS 2.0) Short Form', 'timeFrame': '30 days', 'description': 'Level of functional disability in the past month across six subdomains. Minimum score: 0, Maximum score: 48. Higher scores mean worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-9) Depression Subscale', 'timeFrame': '14 days', 'description': 'Level of depressive symptoms over the past two weeks. Minimum score: 0, Maximum score: 27. Higher scores mean worse outcome.'}, {'measure': 'Generalized Anxiety Disorder 7 (GAD-7) Scale', 'timeFrame': '14 days', 'description': 'Level of generalized anxiety symptoms over the past two weeks. Minimum score: 0, Maximum score: 21. Higher scores mean worse outcome.'}, {'measure': 'Five Factor Mindfulness Questionnaire, Short Form (FFMQ-SF)', 'timeFrame': '30 days', 'description': 'Measure of five core mindfulness skills over the past month (15 items). Minimum score: 15, Maximum score: 75. Higher scores mean greater dispositional mindfulness (good outcome).'}, {'measure': 'Philadelphia Mindfulness Scale', 'timeFrame': '30 days', 'description': 'Measure of mindful acceptance and awareness over the past month (20 items). Minimum score: 20, Maximum score: 100. Higher scores mean greater dispositional mindfulness (good outcome).'}, {'measure': 'Perceived Stress Scale', 'timeFrame': '30 days', 'description': 'Well-validated measure of perceived stress over the past month (10 items). Minimum score: 0, Maximum score: 40. Higher scores mean greater perceived stress (worse outcome).'}, {'measure': 'Ruminative Response Scale, Short Form (Treynor & Nolen-Hoeksema, 2003)', 'timeFrame': '30 days', 'description': 'Measure of ruminative thought patterns over the past 30 days using 10 items. Minimum score: 10, Maximum score: 40. Higher scores mean greater tendency to ruminate (worse outcome).'}, {'measure': 'Repetitive Thinking Questionnaire', 'timeFrame': '30 days', 'description': 'Measure of negative repetitive thought patterns over the past 30 days using 10 items. Minimum score: 10, Maximum score: 50. Higher scores mean greater tendency to experience repetitive thinking (worse outcome).'}, {'measure': 'Penn State Worry Questionnaire', 'timeFrame': '30 days', 'description': 'Measure of worry and rumination over the past 30 days using 16 items. Minimum score: 16, Maximum score: 80. Higher scores mean greater tendency to worry (worse outcome).'}, {'measure': 'Work Productivity and Activity Impairment', 'timeFrame': '30 days', 'description': 'Measure of disruption to work and activities because of mental health symptoms in the past month using 5 items. Scores vary as the scale utilizes open response options to some questions. Higher scores generally indicate more impairment to productivity.'}, {'measure': 'Treatment Acceptability Questionnaire (Hunsley, 1992)', 'timeFrame': '30 days', 'description': "Assesses the patient's perception of the treatment as useful, helpful, and effective using 6 items. Minimum score: 6, Maximum score: 42. Higher scores indicate greater acceptability."}, {'measure': 'MHealth App Usability Questionnaire', 'timeFrame': '30 days', 'description': 'An 18-item measure of the ease of use, acceptability as a treatment, and satisfaction. Minimum score: 18, Maximum score: 126. Higher scores indicate greater usability and satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfulness', 'digital health'], 'conditions': ['Mental Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.camh.ca', 'label': 'Information about research at the Centre for Addiction and Mental Health'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a mindfulness-based meditation app provided to outpatients (or community participants) who are waitlisted for standard psychological care for mental health or substance use concerns.', 'detailedDescription': 'This project aims to provide a previously validated mindfulness meditation app to up to 200 adults waitlisted for psychological services in a psychiatric hospital setting or in the broader community. Outpatients (or community participants) who have been referred to and waitlisted for treatment for their mood, anxiety, alcohol, and/or substance use concerns, will be offered access to the digital intervention for 1 year. We will follow participants for 3 months to evaluate usability and psychological symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-65 years of age\n2. Fluency in English\n3. Understanding and willingness to comply with study requirements\n4. Waitlisted for outpatient psychosocial programming at CAMH (or psychosocial programming in the community)\n5. Smartphone or tablet capable of downloading and running the mindfulness app.\n\nExclusion Criteria:\n\n1. Any known practical factor that would preclude participation (e.g., extended absences)\n2. Acute psychiatric (e.g., acute suicidality, psychosis) or serious medical condition that precludes participation in this study.\n3. Participation in another treatment/intervention study'}, 'identificationModule': {'nctId': 'NCT05211960', 'briefTitle': 'Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions', 'orgStudyIdInfo': {'id': '088/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'AmDTx is a mindfulness-based meditation app that includes lessons, interactive exercises, and additional in-app features to practice mindfulness. Participants will receive a premium account for 1 year; the current study will evaluate outcomes over 3 months. The intervention will be delivered concurrently with treatment as usual which includes standard psychosocial care as participants are referred to their respective programs.', 'interventionNames': ['Behavioral: Mindfulness-based meditation']}], 'interventions': [{'name': 'Mindfulness-based meditation', 'type': 'BEHAVIORAL', 'otherNames': ['AmDTx'], 'description': 'AmDTx is a mindfulness-based meditation app that includes lessons, interactive exercises, and additional in-app features to practice mindfulness.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 2S1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Campbell Family Mental Health Research Institute, CAMH', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Lena C. Quilty, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Lena Quilty', 'investigatorAffiliation': 'Centre for Addiction and Mental Health'}}}}