Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT05138120
Status:
WITHDRAWN
Last Update Posted:
2023-07-12
First Post:
2021-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COMET India Follow-up Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'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': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-11-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-10', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2021-11-16', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.'}, {'measure': 'Change in Generalized Anxiety Disorder Screener-7 (GAD-7)', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.'}, {'measure': 'Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.'}], 'secondaryOutcomes': [{'measure': 'Ratings on the Acceptability of Intervention Measure (AIM)', 'timeFrame': 'Immediately after the intervention', 'description': 'Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate higher acceptability ratings.'}, {'measure': 'Ratings on the Intervention Appropriateness Measure (IAM)', 'timeFrame': 'Immediately after the intervention', 'description': 'Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate higher appropriateness.'}, {'measure': 'Mechanisms of Change', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'Participants answered questions relating to each module\'s mechanism of change on a 7-point Likert Scale, from "strongly disagree" to "strongly agree".\n\nSpecifically, we asked participants:\n\nHow capable they feel about managing negative thoughts; If they will intentionally spend time doing activities they enjoy; If they will notice and appreciate good things; If they will'}, {'measure': 'Secondary Control', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'We asked participants three items to assess secondary control (Weisz et al., 2010). The items are scored on a 4-point Likert scale, ranging from 0 ("Very false") to 3 ("Very true").\n\nThe three items are:\n\nWhen something bad happens, I can find a way to think about it that makes me feel better.\n\nAfter a really hard day, I can make myself feel better by remembering some good things that happened.\n\nWhen bad things happen to me that I can\'t control, there are lots of things I can do to feel better.\n\nHigher scores indicate greater secondary control.'}, {'measure': 'Positive and Negative Affect Schedule', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'Questionnaire measuring positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores representing higher levels of positive affect. Scores on the negative affect subscale range from 10-50, with lower scores representing lower levels of negative affect.'}, {'measure': 'Perceived Stress Scale-4', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Symptoms', 'Anxiety', 'Happiness']}, 'descriptionModule': {'briefSummary': 'We are evaluating an online single-session intervention for mental health promotion among Indian college students.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* College Student\n* Access to internet\n* Proficient in English\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05138120', 'briefTitle': 'COMET India Follow-up Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Evaluating an Online Single-session Intervention (COMET) for Indian College Students', 'orgStudyIdInfo': {'id': '849593'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Common Elements Toolbox', 'interventionNames': ['Behavioral: Common Elements Toolbox']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control'}], 'interventions': [{'name': 'Common Elements Toolbox', 'type': 'BEHAVIORAL', 'description': 'An unguided online single-session intervention with four modules: behavioral activation, cognitive restructuring, gratitude, and self-compassion.', 'armGroupLabels': ['Common Elements Toolbox']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}