Clinical trial NCT06370104: Treating Suicidality Remotely
Official title: Treating Suicidality Remotely: a Randomized Controlled Trial of Brief Cognitive Behavioral Therapy for Suicide Prevention Delivered Via Chat or Phone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Attempt
Keywords: suicide
attempts
ideation
telehealth
e-health
remote
cbt
self-help
Lead sponsor: 113 Suicide Prevention
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC
First posted: 2024-04-17
Enrollment: 364
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trial with a 1:1 allocation ratio.
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Number of suicide attempts
timeFrame: 18-months follow-up
Secondary outcomes:
measure: Severity of suicidal ideation
timeFrame: 18-months follow-up
measure: Severity of suicidal Thoughts and Behaviors Composite
timeFrame: 18-months follow-up
measure: Treatment satisfaction
timeFrame: post-treatment (approximately 12 weeks after the start of treatment)
measure: Adverse effects
timeFrame: post-treatment (approximately 12 weeks after the start of treatment)
measure: Co-occuring mental health issues
timeFrame: 18-months follow-up
measure: Quality of life
timeFrame: 18-months follow-up
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: 113 Suicide Prevention
state: Zuid-Holland
Study officials:
References: