Treating Suicidality Remotely

NCT06370104 | Recruiting

• 1 other identifier: NL85041.018.23
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

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

Keywords

suicide; attempts; ideation; telehealth; e-health; remote; cbt; self-help

Outcome Measures

Primary Outcomes (1)

• Number of suicide attempts

  Number of fatal and non-fatal suicide attempts, identified through the Columbia Suicide Severity Rating Scale (C-SSRS; non-fatal attempts), a contact provided by the participant or Statistics Netherlands (fatal attempts).

  18-months follow-up

Secondary Outcomes (6)

• Severity of suicidal ideation

  18-months follow-up

• Severity of suicidal Thoughts and Behaviors Composite

  18-months follow-up

• Treatment satisfaction

  post-treatment (approximately 12 weeks after the start of treatment)

• Adverse effects

  post-treatment (approximately 12 weeks after the start of treatment)

• Co-occuring mental health issues

  18-months follow-up

Study Arms (2)

Remote Brief Cognitive Behavioral Therapy for Suicide Prevention

EXPERIMENTAL

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.

Behavioral: Brief Cognitive Behavioral Therapy for Suicide Prevention

Remote Semi-guided self-help course

ACTIVE COMPARATOR

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.

Behavioral: Living under control

Interventions

Brief Cognitive Behavioral Therapy for Suicide Prevention BEHAVIORAL

see arm description

Remote Brief Cognitive Behavioral Therapy for Suicide Prevention

Living under control BEHAVIORAL

see arm description

Also known as: Living with deadly thoughts

Remote Semi-guided self-help course

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Currently living in The Netherlands
• Any type of STBs in the past 4 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• 113 Suicide Prevention: lead
• Amsterdam UMC: collaborator

Study Sites (1)

113 Suicide Prevention

Amsterdam, South Holland, 1105BP, Netherlands

RECRUITING

MeSH Terms

Conditions

Suicide, Attempted; Suicide; Color Vision Defects

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants are not blind to the treatment condition, but are unaware which is the experimental condition and which the control condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel randomized controlled trial with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 17, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): April 25, 2028
• Study Completion (Estimated): April 25, 2028
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: within two years after data collection has been completed

Locations

NL (1)