Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 6:47 PM
Study NCT ID:
NCT05715034
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2023-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-Session Web-Based Training in Self-Compassion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 365}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Stress symptoms', 'timeFrame': 'Baseline to 2-week follow-up', 'description': 'Perceived Stress Scale (PSS-10). Total scores range from 0 to 40 with higher scores indicating greater stress symptoms'}, {'measure': 'Change in Anxiety symptoms', 'timeFrame': 'Baseline to 2-week follow-up', 'description': 'General Anxiety Disorder-7 (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.'}, {'measure': 'Change in Depressive symptoms', 'timeFrame': 'Baseline to 2-week follow-up', 'description': 'Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptoms.'}, {'measure': 'Change in Functional Impairment', 'timeFrame': 'Baseline to 2-week follow-up', 'description': 'Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment.'}], 'secondaryOutcomes': [{'measure': 'Change in Self-Compassion', 'timeFrame': 'Baseline to 2-week follow-up', 'description': 'Self-Compassion Scale (SCS). Total scores are the average of each of the subscales, and range from 0 to 5. Higher scores indicate greater self-compassion.'}, {'measure': 'Change in Mindfulness', 'timeFrame': 'Baseline to 2-week follow-up', 'description': 'Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized controlled trial', 'Self-Compassion'], 'conditions': ['Stress', 'Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': 'Two-arm, parallel group randomized clinical trial conducted via Mturk comparing a single-session web-based intervention called Compassionate Care versus a control intervention (nature videos with relaxing music) for adults with moderate-to-severe stress, depression and/or anxiety symptoms.', 'detailedDescription': 'Procedures include completing: (1) pre-intervention baseline assessment; (2) one of two single-session web-based intervention (approximately 30 to 45 minutes each); (3) a brief post-intervention survey; and (4) a 2-week follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Fluent in English\n* At least moderate stress, anxiety and/or depressive symptoms, as indicated by a score of:\n\n 14 or higher on the PSS-10, and/or 10 or higher on the GAD-7, and/or 10 or higher on the PHQ-9\n\nExclusion Criteria:\n\n* Fail to meet above-listed inclusion criteria\n* Do not pass attention/data quality checks in initial screening or study assessments, including:\n* Obvious lack of English fluency in open response questions\n* Responding with random text in open response questions\n* Respond with either copy/pasted responses from text earlier in the intervention to any of free response questions\n* Participants with a completion time less than an average of 1.5 seconds per question for the baseline survey assessment OR who fail all three attention check questions in the baseline survey, indicating very careless, random, inattentive and/or hasty responding\n* Exit the study prior to condition randomization'}, 'identificationModule': {'nctId': 'NCT05715034', 'briefTitle': 'Single-Session Web-Based Training in Self-Compassion', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Pilot Randomized Trial of Compassionate Care: A Single-Session Web-Based Training in Self-Compassion Among Adults With Stress, Anxiety, and/or Depressive Symptoms', 'orgStudyIdInfo': {'id': '2000033574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Compassionate Care', 'description': 'Single-session, self-guided web-based intervention (\\~45 minutes) hosted on Qualtrics with animated videos, audio-guided exercises, graphics, text-based material, and interactive questions. This intervention is designed to teach participants about mindfulness and self-compassion.', 'interventionNames': ['Behavioral: Compassionate Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxing with Nature', 'description': 'Single-session self-guided web-based intervention (\\~30 to 45 minutes) hosted on Qualtrics with videos (real-life images), text-based material, and questions. Each video includes a sequence of pleasant nature photos (shown about 6 seconds each) with relaxing music in the background.', 'interventionNames': ['Behavioral: Relaxing with Nature']}], 'interventions': [{'name': 'Compassionate Care', 'type': 'BEHAVIORAL', 'description': 'Single-session web-based program', 'armGroupLabels': ['Compassionate Care']}, {'name': 'Relaxing with Nature', 'type': 'BEHAVIORAL', 'description': 'Single-session web-based program', 'armGroupLabels': ['Relaxing with Nature']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'In compliance with HIPAA and Yale Human Investigation Committee standards, any data sets that will be shared will not include any personally identifiable information. Requests for data sharing will be considered within the context of ongoing and planned research being performed within the research group at Yale in order to avoid duplication of effort and overlap in data analysis that might compromise communication of findings. Data to be shared will be de-identified and transmission electronically and securely, as we have done previously with investigators at other institutions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}