Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT04230434
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2019-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D013406', 'term': 'Suicide, Attempted'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D000092864', 'term': 'Suicide Prevention'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Interventional cohort (Safety Plan Intervention)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2019-11-29', 'studyFirstSubmitQcDate': '2020-01-14', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Predictive ability of the clinician in the subsequent conduct suicidal patient', 'timeFrame': 'Baseline', 'description': 'is measured through a dichotomous question in which the professional will make a prognosis about the possibility that the patient may return to commit a suicidal behaviour.'}], 'primaryOutcomes': [{'measure': 'Feasibility of Safety Plan Implementation', 'timeFrame': 'Baseline', 'description': 'Percentage of SPIs performed in ED from total number of suicide related ED visits.'}], 'secondaryOutcomes': [{'measure': 'Time required for the performance of the SPI', 'timeFrame': 'Baseline', 'description': 'Minutes required for the performance of the SPI'}, {'measure': 'Satisfaction of the patient with the Safety Plan', 'timeFrame': 't0 (Safety Plan Performance )', 'description': 'Likert-type scales with 5 levels of response will be measured through questions: "To what extent do the Safety Plan can help you to avoid a new situation of suicidal risk?"'}, {'measure': 'Satisfaction of the Professional with the Safety Plan', 'timeFrame': 'Baseline', 'description': 'Likert-type with 5 levels of response will be measured through questions: "To what extent do the Safety Plan can help you to avoid a new situation of suicidal risk?" Likert-type with 5 levels of response will be measured through questions: "To what extent the Safety Plan did you useful for the patient?". Open questions can be explained where contributions and obstacles encountered in its implementation will also be formulated.'}, {'measure': 'Presence of suicide reattempt', 'timeFrame': 'Month 6', 'description': 'Percentage of patients that commit suicide reattempt.'}, {'measure': 'Time to suicide reattempt', 'timeFrame': 'Month 6', 'description': 'Days from suicide attempt attended in the ED to the next suicide reattempt.'}, {'measure': 'Adherence to psychiatric ambulatory follow-up', 'timeFrame': 'Month 6', 'description': 'Percentage of patients that attend psychiatric ambulatory follow-up after ED discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Suicide', 'Suicidal behavior', 'Suicidal attempt', 'Suicide prevention', 'Safety Planning Intervention'], 'conditions': ['Suicide', 'Suicide, Attempted', 'Suicidal Ideation']}, 'descriptionModule': {'briefSummary': 'The Safety Plan Intervention (SPI) has demonstrated to reduce suicide reattempts and to increase the ambulatory follow-up in american war veterans. This study evaluates the implementability and effectiveness in a significantly different population in a real world setting.', 'detailedDescription': 'We will perform a Effectiveness-implementation Hybrid Design (Curran et al. 2012) to study firstly the feasibility of implementing the SPI in our clinical setting and secondly its effectiveness. The experimental arm will consist in a group of patients who visit the ED for a suicide-related concern in which the SPI is performed. This will be in the Emergency Department , unless for clinical reasons, the ED psychiatrist decide to postpone it to the first psychiatric appointment (which will be before one week of the ED visit as part of the treatment as usual).\n\nRight after the SPI is performed, both the patient and the clinician will complete questionnaire with satisfaction and acceptability measures. Subjects will be followed for 6 months. At this time medical records will be consulted to obtain suicide reattempts rates and follow-up adherence.\n\nAt all times, the anonymity of the participants will be preserved and will require heading of informed consent, as well as other ethical aspects indicated by the Ethics Committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Suicide attempt or presence of severe suicidal ideation\n2. Signed Informed Consent Form\n\nExclusion criteria:\n\n1. Less than 18 years old\n2. Hospitalization in the Psychiatry Department\n3. Inability to understand the Safety Planning Intervention\n\nWithdrawal criteria:\n\n1\\) Participant's decision to withdraw from the trial"}, 'identificationModule': {'nctId': 'NCT04230434', 'briefTitle': 'Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Hospital Universitario La Paz'}, 'officialTitle': 'Safety-Planning Intervention for Suicidal Behavior in an Emergency Department: an Effectiveness-implementation Hybrid Design', 'orgStudyIdInfo': {'id': 'SPI-EI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety Plan Intervention', 'description': 'The Safety Plan Intervention (SPI) performed in ED or in ambulatory appointment', 'interventionNames': ['Behavioral: Safety Plan Intervention']}], 'interventions': [{'name': 'Safety Plan Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Security Plan'], 'description': 'The SPI has 6 key steps: (1) identify personalized warning signs for an impending suicide crisis; (2) determine internal coping strategies that distract from suicidal thoughts and urges; (3) identify family and friends who are able to distract from suicidal thoughts and urges and social places that provide the opportunity for interaction; (4) identify individuals who can help provide support during a suicidal crisis; (5) list mental health professionals and urgent care services to contact during a suicidal crisis; and (6) lethal means counseling for making the environment safer (Stanley \\& Brown, 2012)', 'armGroupLabels': ['Safety Plan Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28029', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'La Paz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Beatriz Rodriguez Vega, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Investigación Hospital Universitario La Paz'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will be available one year after publishing the final results for at least 5 years', 'ipdSharing': 'YES', 'description': 'Data will be shared with other researchers on request', 'accessCriteria': 'Please contact PI Beatriz Rodríguez-Vega (beatrizrvega@gmail.com)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}