Treating Suicidality Remotely

NCT ID: NCT06370104

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2028-04-25

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.

Conditions

Suicide Attempt

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Remote Brief Cognitive Behavioral Therapy for Suicide Prevention

Participants in the experimental condition will be treated with online CBT-SP, a personalized intervention of approximately 12 sessions via chat or phone, in which therapist and client create a safety plan, try to restrict the access to lethal means and use a narrative assessment of a recent suicidal crisis to create a case formulation. This case formulation is then used to choose from several treatment modules, such as dealing with unhelpful thoughts and reducing sleep problems.

Group Type: EXPERIMENTAL

Brief Cognitive Behavioral Therapy for Suicide Prevention

Intervention Type: BEHAVIORAL

see arm description

Remote Semi-guided self-help course

Participants in the control group will be treated with a self-help course, in which they are given psychoeducation on suicidal thoughts, create a safety plan and are thought several techniques from cognitive therapy, such as cognitive restructuring and worry times. The course consists of 6 sessions, on which subjects receive feedback from a therapist. In this study, feedback will be given in a live conversation with the therapist via chat or phone, instead of via e-mail, to increase safety and reduce the difference in attention between the groups.

Group Type: ACTIVE_COMPARATOR

Living under control

Intervention Type: BEHAVIORAL

see arm description

Interventions

Brief Cognitive Behavioral Therapy for Suicide Prevention

see arm description

Intervention Type: BEHAVIORAL

Living under control

see arm description

Intervention Type: BEHAVIORAL

Other Intervention Names

Living with deadly thoughts

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC

OTHER

Sponsor Role: collaborator

113 Suicide Prevention

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

113 Suicide Prevention

Amsterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Wilco Janssen, MSc

Role: primary

w.janssen@113.nl

020 3 113 883

Saskia Mérelle, PhD

Role: backup

s.merelle@113.nl

020 3 113 883

Other Identifiers

NL85041.018.23

Identifier Type: -

Identifier Source: org_study_id