Nctid:
NCT06614946
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000013405", "term"=>"Suicide"}, {"id"=>"D000059020", "term"=>"Suicidal Ideation"}, {"id"=>"D000013406", "term"=>"Suicide, Attempted"}], "ancestors"=>[{"id"=>"D000016728", "term"=>"Self-Injurious Behavior"}, {"id"=>"D000001526", "term"=>"Behavioral Symptoms"}], "browseLeaves"=>[{"id"=>"M7796", "name"=>"Emergencies", "relevance"=>"LOW"}, {"id"=>"M16191", "name"=>"Suicide", "asFound"=>"Suicide", "relevance"=>"HIGH"}, {"id"=>"M29364", "name"=>"Suicidal Ideation", "asFound"=>"Suicidal Ideation", "relevance"=>"HIGH"}, {"id"=>"M16192", "name"=>"Suicide, Attempted", "asFound"=>"Suicide, Attempted", "relevance"=>"HIGH"}, {"id"=>"M19089", "name"=>"Self-Injurious Behavior", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"There are 2 arms: ESP only and ESP with text-based program. The ESP with text-based program arm includes twice daily (within-person) randomizations."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>120}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-12", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-09", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-09", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Percentage of eligible individuals who agree to participate", "timeFrame"=>"At the time of ED 1 day visit"}, {"measure"=>"Completion of the one-month follow-up assessment survey", "timeFrame"=>"One month post-discharge from the ED"}, {"measure"=>"Completion of the three-month follow-up assessment survey", "timeFrame"=>"Three months post-discharge from the ED"}, {"measure"=>"Number of withdrawals", "timeFrame"=>"Up to 3 months post-discharge from the ED"}, {"measure"=>"Percentage of participants who remain active (in text-support condition only)", "timeFrame"=>"Up to 28 days post-discharge from the ED"}, {"measure"=>"Participant satisfaction with the intervention components", "timeFrame"=>"Up to 1 months", "description"=>"Measured with a modified Client Satisfaction Questionnaire (CSQ)."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Emergency Department"], "conditions"=>["Suicidal", "Suicide, Attempted", "Suicidal Ideation"]}, "descriptionModule"=>{"briefSummary"=>"The researchers hope to learn whether an electronic safety plan (ESP) and a supportive text messaging program are feasible and acceptable to adult patients with recent suicidal thoughts or behavior after emergency department (ED) discharge. From this study, the researchers also hope to learn how to best carry out the ESP and text messaging program to improve outcomes for patients after ED discharge."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nIndividuals presenting to an ED with either:\n\n1. actual, interrupted, or aborted attempt in the last 4 weeks\n2. suicidal ideation within the last week\n\nExclusion Criteria:\n\n* Severe cognitive impairment or altered mental status (psychosis, manic state)\n* Severe aggression/agitation,\n* Being admitted or transferred into inpatient care,\n* Patient not owning a cell phone with text messaging capability"}, "identificationModule"=>{"nctId"=>"NCT06614946", "briefTitle"=>"Improving Coping to Reduce Suicide Risk Following ED Discharge", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Michigan"}, "officialTitle"=>"Facilitating Effective Coping to Reduce Suicide Risk Following ED Discharge: A Micro-randomized Trial to Develop an Adaptive Text-based Intervention", "orgStudyIdInfo"=>{"id"=>"HUM00244094"}, "secondaryIdInfos"=>[{"id"=>"R34MH133057", "link"=>"https://reporter.nih.gov/quickSearch/R34MH133057", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Electronic safety plan (ESP) + Text-Based Support", "description"=>"Participants who are randomized to this arm will receive ESP during ED care and receive a text-based support program for 4 weeks after discharge, with up to 2 messages per day. The text-based program includes a microrandomized trial (MRT), where participants are randomized twice daily to receive or not receive a message.", "interventionNames"=>["Behavioral: Electronic Safety Plan (ESP)", "Behavioral: Text support"]}, {"type"=>"EXPERIMENTAL", "label"=>"Enhanced electronic safety plan (ESP) enhanced with 2 reminder text messages with ESP link", "interventionNames"=>["Behavioral: Electronic Safety Plan (ESP)"]}], "interventions"=>[{"name"=>"Electronic Safety Plan (ESP)", "type"=>"BEHAVIORAL", "description"=>"Participants will receive an electronic safety plan in the ED. ESP focuses on developing a personalized coping plan to manage suicidal thoughts and urges.", "armGroupLabels"=>["Electronic safety plan (ESP) + Text-Based Support", "Enhanced electronic safety plan (ESP) enhanced with 2 reminder text messages with ESP link"]}, {"name"=>"Text support", "type"=>"BEHAVIORAL", "description"=>"Those in the text-based support program will receive up to 2 texts per day for a month with varying levels of tailoring, based on ESP and dynamic personalized feedback.", "armGroupLabels"=>["Electronic safety plan (ESP) + Text-Based Support"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"48109", "city"=>"Ann Arbor", "state"=>"Michigan", "country"=>"United States", "contacts"=>[{"name"=>"Ewa Czyz", "role"=>"CONTACT", "email"=>"ewac@umich.edu", "phone"=>"734-764-9466"}, {"name"=>"Adam Horwitz, Ph.D.", "role"=>"CONTACT", "email"=>"ahor@med.umich.edu", "phone"=>"734-764-0231"}, {"name"=>"Ewa Czyz, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Adam Horwitz, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University of Michigan", "geoPoint"=>{"lat"=>42.27756, "lon"=>-83.74088}}], "centralContacts"=>[{"name"=>"Ewa Czyz", "role"=>"CONTACT", "email"=>"ewac@umich.edu", "phone"=>"734-764-9466"}], "overallOfficials"=>[{"name"=>"Ewa Czyz, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Michigan"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Michigan", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute of Mental Health (NIMH)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor of Psychiatry", "investigatorFullName"=>"Ewa Czyz", "investigatorAffiliation"=>"University of Michigan"}}}}
