Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT04781166
Status:
TERMINATED
Last Update Posted:
2023-11-18
First Post:
2021-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Interview-based assessments will be conducted by personnel who are unaware of treatment condition.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Adult participants will be enrolled in the intervention, and we will use pre-, post-data to evaluate whether the program appears to be helpful. Adolescent participants will be randomly assigned to a waitlist control or intervention; those in the waitlist will be offered the intervention after they complete the waitlist period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Lack of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in suicidal ideation among adults', 'timeFrame': 'immediately before the intervention and one week after intervention', 'description': 'Columbia Suicide Severity Rating scale suicidal ideation severity score; scores range from 0 to 5, where 5 is more severe.'}, {'measure': 'Change in interview-rated suicidal ideation among adolescent patients', 'timeFrame': 'immediately before the intervention and one week after intervention', 'description': 'Self-Injurious Thoughts and Behaviors Interview suicidal ideation in the past month scored as the sum of the items on the worst intensity, average intensity, and likelihood of suicidal ideation items; scores range from 0 to 12, with higher scores reflecting greater severity.'}, {'measure': 'Change in self-rated suicidal ideation among adolescent patients', 'timeFrame': 'immediately before the intervention and one week after intervention', 'description': 'Suicide Ideation Questionnaire Jr; scores range from 0 to 6, where 6 is more severe'}, {'measure': 'Change in self-rated deliberate self-harm', 'timeFrame': 'immediately before the intervention and one week after intervention', 'description': 'Deliberate Self-Harm Inventory Frequency in past month score, from 0 to number of incidents reported (higher scores are worse outcomes)'}, {'measure': 'Change in interview-based self-harm among adolescent patients', 'timeFrame': 'immediately before the intervention and one week after intervention', 'description': 'Self-Injurious Thoughts and Behaviors Interview NSSI severity in the past month, scored as the sum of the items on the worst intensity, average intensity, and likelihood of NSSI items; scores range from 0 to 12 with higher scores reflecting greater severity.'}, {'measure': 'Change in impulsivity', 'timeFrame': 'immediately before the intervention and one week after intervention', 'description': 'self-rated Three factor impulsivity Feelings Trigger Action subscale; scores range from 1 to 5, where 5 reflects more severe impulsivity'}, {'measure': 'Change in interview-based impulsivity among adolescent patients', 'timeFrame': 'immediately before the intervention and one week after intervention', 'description': 'Urgency interview scores, scored as the sum of 8 items, range = 0 to 16, where higher scores reflect more impulsivity.'}], 'secondaryOutcomes': [{'measure': 'Change in aggression', 'timeFrame': 'immediately before the intervention and one week after intervention', 'description': 'Bryant Aggression scale: mean of physical aggression, verbal aggression, and anger subscales; range of scores from 1 to 5, where 5 = more severe aggression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicidal Ideation', 'Deliberate Self-harm', 'Impulsivity']}, 'descriptionModule': {'briefSummary': 'The goal of this program is to test a brief, online, cognitive behavioral intervention for people who struggle with self-harm or suicidal urges or behavior in the context of emotion-related impulsivity.', 'detailedDescription': 'Participants will be asked to complete 7 brief online modules to cover how to understand emotion-triggered impulsivity, to better detect states of high emotion and arousal, to learn new strategies for self-calming high arousal, and to pre-plan how to cope with high arousal states. As part of the program, participants receive daily texts and prompts to remind them of the intervention content and skills. At baseline and follow-up, participants will complete measures of emotion-related impulsivity, self-harm, and suicidality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 13 years of age\n* engaged in mental health care\n* evidence of either self-harm or suicidal urges or behavior in the past 3 months\n* high levels of emotion-related impulsivity.\n\nExclusion Criteria:\n\n* inability to adequately take part in the online measures due to problems with intellectual function, language, or other conditions,\n* psychosis,\n* not currently living in California,\n* lack of access to a device to privately complete online modules.'}, 'identificationModule': {'nctId': 'NCT04781166', 'briefTitle': 'An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related', 'orgStudyIdInfo': {'id': 'UC CPHS 2016-01-8287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants will be immediately assigned to the intervention.', 'interventionNames': ['Behavioral: Calm program']}, {'type': 'OTHER', 'label': 'Waitlist control', 'description': 'Participants will complete measures before and after a waitlist equivalent to the duration of the intervention, to assess whether change is observed with time and repeated assessment. After the waitlist control, participants will be provided the opportunity to take part in the intervention. In this RDICT design, the pre- post- treatment data will be included in analyses.', 'interventionNames': ['Behavioral: Calm program']}], 'interventions': [{'name': 'Calm program', 'type': 'BEHAVIORAL', 'description': '7 online modules designed to teach cognitive behavioral skills', 'armGroupLabels': ['Intervention', 'Waitlist control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94720', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'overallOfficials': [{'name': 'Sheri L Johnson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'We will upload data at the time we submit the article for publication. Data will be available for 7 years.', 'ipdSharing': 'YES', 'description': 'We will provide fully de-identified data on OSF.', 'accessCriteria': 'Data will be available to authorized users of the OSF website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sheri L. Johnson', 'investigatorAffiliation': 'University of California, Berkeley'}}}}