protocolSection identificationModule nctId: NCT06370104, orgStudyIdInfo id: NL85041.018.23, briefTitle: Treating Suicidality Remotely, acronym: TREASURE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2028-04-25, completionDateStruct date: 2028-04-25, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: 113 Suicide Prevention, class: OTHER, collaborators name: Amsterdam UMC, descriptionModule briefSummary: Background: Practical and psychological barriers make it difficult for people with Suicidal Thoughts and Behaviors (STBs) to get professional help. Online interventions have the potential to overcome many of these barriers, but the online interventions to date have produced small or short-lived effects and have only been found to reduce suicidal thoughts, not behaviors. This is a crucial limitation, since previous studies have shown that interventions that reduce suicidal thoughts often do not prevent suicide attempts, and vice versa.Methods: A fully remote randomized controlled trial will be conducted in which 364 participants of 16 years and older will be recruited through the website of a suicide prevention helpline in the Netherlands and randomized with an allocation ratio of 1:1 to either Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT-SP) or a semi-guided online self-help course that has previously been found superior to waitlist in reducing suicidal thoughts. The primary outcome of the study is the number of suicide attempts, measured with the Columbia Suicide Severity Rating Scale. Secondary outcomes are self-reported suicidal ideation, healthcare utilization, treatment satisfaction, adverse effects, and quality of life. All outcomes will be assessed at baseline, immediately after the treatment and at 18 months follow-up.Discussion: If remote BCBT-SP proves effective, the findings of this study will add to the evidence base of BCBT-SP as one of very few psychological interventions with replicated effectiveness in preventing suicide attempts and provide the first evidence to date that remote interventions cannot only reduce suicidal thoughts, but also prevent suicidal behavior., conditionsModule conditions: Suicide Attempt, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel randomized controlled trial with a 1:1 allocation ratio., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Participants are not blind to the treatment condition, but are unaware which is the experimental condition and which the control condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 364, type: ESTIMATED, armsInterventionsModule interventions name: Brief Cognitive Behavioral Therapy for Suicide Prevention, interventions name: Living under control, outcomesModule primaryOutcomes measure: Number of suicide attempts, secondaryOutcomes measure: Severity of suicidal ideation, secondaryOutcomes measure: Severity of suicidal Thoughts and Behaviors Composite, secondaryOutcomes measure: Treatment satisfaction, secondaryOutcomes measure: Adverse effects, secondaryOutcomes measure: Co-occuring mental health issues, secondaryOutcomes measure: Quality of life, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 113 Suicide Prevention, city: Amsterdam, state: Zuid-Holland, zip: 1105BP, country: Netherlands, contacts name: Wilco Janssen, MSc, role: CONTACT, phone: 020 3 113 883, email: w.janssen@113.nl, contacts name: Saskia Mérelle, PhD, role: CONTACT, phone: 020 3 113 883, email: s.merelle@113.nl, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False