Suicide AttemptTREASURENCT06370104
Treating Suicidality Remotely
A study testing Brief Cognitive Behavioral Therapy for Suicide Prevention in people with Suicide Attempt, run by 113 Suicide Prevention at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Suicide Attempt
- What is being tested?
- Brief Cognitive Behavioral Therapy for Suicide Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 May 2024to 25 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 years or older
- Currently living in The Netherlands
- Any type of STBs in the past 4 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
113 Suicide Prevention
Amsterdam, South Holland, 1105BP
Wilco Janssen, MSc, 020 3 113 883, w.janssen@113.nl
Saskia Mérelle, PhD, 020 3 113 883, s.merelle@113.nl
About this study
Official title: Treating Suicidality Remotely: a Randomized Controlled Trial of Brief Cognitive Behavioral Therapy for Suicide Prevention Delivered Via Chat or Phone
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
- Being tested
- Brief Cognitive Behavioral Therapy for Suicide Prevention, Living under control
- Keywords
- suicide, attempts, ideation, telehealth, e-health, remote, cbt, self-help
- Medical subject headings
- Suicide, Attempted, Suicide, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Cognitive Behavioral Therapy for Suicide PreventionBehavioural
see arm description
Living under controlBehavioural
Also called Living with deadly thoughts
see arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Living under control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18-months follow-up
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 18-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start7 May 2024
- Primary completion25 Apr 2028 (estimated)
- Study completion25 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide AttemptStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized controlled trial with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 113 Suicide Prevention
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370104
- Sponsor's protocol ID
- NL85041.018.23
- Acronym
- TREASURE
- Status last verified
- May 2024
- First submitted
- 8 Apr 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Janssen W, Merelle S, Gilissen R, Bockting C. Treating suicidality remotely (TREASURE): study protocol for a remote randomized controlled trial comparing personalized cognitive behavioral therapy for suicide prevention with a guided self-help course in adolescents and adults. Trials. 2026 Apr 22;27(1):411. doi: 10.1186/s13063-026-09725-0.
PubMed 42015291
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Suicidality Remotely: a Randomized Controlled Trial of Brief Cognitive Behavioral Therapy for Suicide Prevention Delivered Via Chat or Phone
- ClinicalTrials.gov ID
- NCT06370104
- Acronym / sponsor ID
- TREASURE / NL85041.018.23
- Conditions
- Suicide Attempt
- Keywords
- suicide, attempts, ideation, telehealth, e-health, remote, cbt, self-help
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- 113 Suicide PreventionUniversity, hospital or other
- Collaborators
- Amsterdam UMC
- Study start
- 7 May 2024 (actual)
- Primary completion
- 25 Apr 2028 (estimated)
- Study completion
- 25 Apr 2028 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Remote Brief Cognitive Behavioral Therapy for Suicide Prevention | Experimental | Behavioral: Brief Cognitive Behavioral Therapy for Suicide PreventionParticipants 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. |
| Remote Semi-guided self-help course | Active comparator | Behavioral: Living under controlParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 16 years or older
- Currently living in The Netherlands
- Any type of STBs in the past 4 weeks
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Cognitive Behavioral Therapy for Suicide Preventionsee arm description | Behavioural | Remote Brief Cognitive Behavioral Therapy for Suicide Prevention |
| Living under controlAlso: Living with deadly thoughtssee arm description | Behavioural | Remote Semi-guided self-help course |
Primary outcome
Number of suicide attempts
Time frame: 18-months follow-up
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).
6 secondary outcomes
Severity of suicidal ideation
Time frame: 18-months follow-up
Severity of suicidal Thoughts and Behaviors Composite
Time frame: 18-months follow-up
Treatment satisfaction
Time frame: post-treatment (approximately 12 weeks after the start of treatment)
Adverse effects
Time frame: post-treatment (approximately 12 weeks after the start of treatment)
Co-occuring mental health issues
Time frame: 18-months follow-up
Quality of life
Time frame: 18-months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Derived from this study: PubMed 42015291Janssen W, Merelle S, Gilissen R, Bockting C. Treating suicidality remotely (TREASURE): study protocol for a remote randomized controlled trial comparing personalized cognitive behavioral therapy for suicide prevention with a guided self-help course in adolescents and adults. Trials. 2026 Apr 22;27(1):411. doi: 10.1186/s13063-026-09725-0.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Cognitive Behavioral Therapy for Suicide Prevention in people with Suicide Attempt, run by 113 Suicide Prevention at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of suicide attempts (time frame: 18-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06370104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.