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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
364
see arm description
see arm description
113 Suicide Prevention
Amsterdam, South Holland, Netherlands
RECRUITINGNumber 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).
Time frame: 18-months follow-up
Severity of suicidal ideation
Severity of suicidal ideation as measured with the suicidal ideation subscale of the Suicide Severity Rating Scale. This sub scale results in a score from 1-5 based on the most severe type of suicidal ideation endorsed by the subject. For this study, subjects who do not report any suicidal ideation are assigned a score of 0.
Time frame: 18-months follow-up
Severity of suicidal Thoughts and Behaviors Composite
A total score for STB severity will be derived from the Columbia Suicide Severity Rating Scale: subjects who report no suicidal thoughts or behaviors will be assigned a score of 0; subjects who report suicidal thoughts but not behaviors a score of 1-5, depending on their rating on the suicidal ideation subscale described above; subjects who report preparatory behavior but no attempt a score of 6; subjects who report an aborted attempt a score of 7; subjects who report an interrupted attempt a score of 8; and subjects who report a non-lethal attempt a score of 9. Subjects who have made a lethal attempt will be assigned a score of 10.
Time frame: 18-months follow-up
Treatment satisfaction
Treatment satisfaction as measured with the Client Satisfaction Questionnaire 8 (CSQ-8). The subject's scores on the 8 items of the scale are summed up, resulting in a score between 8 and 32, with higher values indicating higher satisfaction.
Time frame: post-treatment (approximately 12 weeks after the start of treatment)
Adverse effects
Adverse effects as measured with the 20-item version of the Negative Effects Questionnaire (NEQ). The mean number of negative effects that clients report and attribute to the treatment is calculated.
Time frame: post-treatment (approximately 12 weeks after the start of treatment)
Co-occuring mental health issues
Co-occuring mental health issues as measured with the MINI neuropsychiatric interview - simplified. Two scores are calculated: * the mean number of symptoms per client * the mean number of classifications per client
Time frame: 18-months follow-up
Quality of life
Quality of life as measured with the Mental Health Quality of Life Questionnaire. An overall index score is calculated by summing the scores of the seven questions. This index score can vary from 0 to 21, with higher scores indicating better quality of life.
Time frame: 18-months follow-up
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