Treating Suicidality Remotely

Suicide Attempt Clinical Trial

— TREASURE  

Official title:

Treating Suicidality Remotely: a Randomized Controlled Trial of Brief Cognitive Behavioral Therapy for Suicide Prevention Delivered Via Chat or Phone

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370104
• Other study ID #: NL85041.018.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: April 25, 2028

Study information

• Verified date: April 2024
• Source: 113 Suicide Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 364
• Est. completion date: April 25, 2028
• Est. primary completion date: April 25, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide Attempt
• Suicide, Attempted

Intervention

Behavioral:
• Brief Cognitive Behavioral Therapy for Suicide Prevention
see arm description
• Living under control
see arm description

Locations

Country	Name	City	State
Netherlands	113 Suicide Prevention	Amsterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
113 Suicide Prevention	Amsterdam UMC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	18-months follow-up
Secondary	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.	18-months follow-up
Secondary	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.	post-treatment (approximately 12 weeks after the start of treatment)
Secondary	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.	post-treatment (approximately 12 weeks after the start of treatment)
Secondary	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	18-months follow-up
Secondary	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.	18-months follow-up