| NCT ID | NCT06370104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | 113 Suicide Prevention |
| Condition | Suicide Attempt |
| Study Type | INTERVENTIONAL |
| Enrollment | 364 participants |
| Start Date | 2024-05-07 |
| Primary Completion | 2028-04-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 364 participants in total. It began in 2024-05-07 with a primary completion date of 2028-04-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 16 years or older * Currently living in The Netherlands * Any type of STBs in the past 4 weeks Exclusion Criteria: * Insufficient mastery of the Dutch language * Previously engaged in 113 Suicide Prevention's Online Therapy or Self-help course * Currently seeing a mental health professional at least once every 3 weeks, other then a general practitioner or general practice based nurse practitioner ('POH-GGZ') * Not able to engage in online therapy, for instance because of severe mood disorders or psychotic symptoms, based on the clinical impression of the research assistant and a supervisor
Frequently Asked Questions
Who can join the NCT06370104 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Suicide Attempt. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06370104 currently recruiting?
Yes, NCT06370104 is actively recruiting participants. Visit ClinicalTrials.gov or contact 113 Suicide Prevention to inquire about joining.
Where is the NCT06370104 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06370104 clinical trial?
NCT06370104 is sponsored by 113 Suicide Prevention. The trial plans to enroll 364 participants.