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.

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 - PMC Skip to main content An official website of the United States government Here's how you know Here's how you know Search Log in Primary site navigation Search Log in Search PMC Full-Text Archive Search in PMC Journal List User Guide As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health. Learn more: PMC Disclaimer | PMC Copyright Notice Trials . 2026 Apr 22;27:411. doi: 10.1186/s13063-026-09725-0 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 Wilco Janssen 1, 2, ✉ , Saskia Mérelle 3 , Renske Gilissen 3, 4 , Claudi Bockting 2 Author information Article notes Copyright and License information 1 113 Suicide Prevention, Amsterdam University Medical Center, Amsterdam, The Netherlands 2 Amsterdam University Medical Center, Amsterdam, The Netherlands 3 113 Suicide Prevention, Amsterdam, The Netherlands 4 Leiden University, Leiden, The Netherlands ✉ Corresponding author. Received 2024 May 24; Accepted 2026 Apr 10; Collection date 2026. © The Author(s) 2026 Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/ . PMC Copyright notice PMCID: PMC13231569  PMID: 42015291 Abstract Background Practical and psychological barriers make it difficult for people with Suicidal Thoughts and Behaviors (STBs) to obtain professional help. Remote interventions have the potential to overcome many of these barriers, but the remote interventions to date have produced small or short-lived effects and only reduced suicidal thoughts, not behaviors. Aims This study therefore aims to evaluate the effectiveness of remotely delivered brief cognitive behavioral therapy for suicide prevention (BCBT) in preventing suicide attempts in a fully remote randomized controlled trial, in which it will be compared to an online self-help course that has previously been found to be effective in reducing suicidal thoughts. Methods A randomized controlled trial will be conducted in which 364 participants aged 16 years and older will be recruited through the website of the Dutch suicide prevention helpline and randomized at a ratio of 1:1 to one of two interventions, both delivered via chat or phone. Participants in the experimental condition will receive BCBT. This intervention consists of approximately 12 sessions in which a narrative assessment of a recent suicidal crisis is used to create a personalized treatment plan out of several modules, such as cognitive restructuring, mindfulness and means restriction. Participants in the control group will receive a semiguided self-help course, which includes 6 lessons and 6 feedback sessions with a therapist, focusing predominantly on psychoeducation and cognitive restructuring. The primary outcome of the study is the number of suicide attempts, measured with the Columbia Suicide Severity Rating Scale (C-SSRS). Secondary outcomes are the self-reported severity of suicidal ideation, treatment satisfaction, adverse effects, and quality of life. All outcomes will be assessed at baseline, immediately after treatment and at 18-month follow-up. Discussion If remote BCBT proves effective, the findings of this study will add to the evidence base of BCBT as one of few replicated psychological interventions that can reduce suicide attempts and pave the way for the wider dissemination of this remote intervention. Trial registration Clinicaltrials.gov NCT06370104 . Registered on April 8, 2024. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-026-09725-0. Keywords: e-health, Telehealth, CBT, Self-help, Suicide, Attempts, Ideation, Adolescents, Young adults, Adults Introduction Background and rationale {6a} Suicide is one of the leading causes of death worldwide, especially among young people [ 57 ]. There are effective interventions to prevent suicidal thoughts and behaviors (STBs), but the effects of these treatments are limited [ 11 , 12 ] and many people never receive them [ 43 ]: most suicides occur in areas where mental health services are scarce [ 57 ], and barriers such as waiting lists, stigma and fear of involuntary hospitalization make it difficult for people with STBs to seek help [ 18 ]. Remote interventions, delivered online or by telephone, are a promising way to reduce such barriers: people do not have to travel, often have few or no contact with a counsellor, and can sometimes remain anonymous. This makes remote interventions more accessible and affordable than offline interventions. Indeed, adults with suicidal ideation tend to prefer remote treatment over face-to-face treatment, and this preference is more pronounced among people with more severe suicidal ideation [ 56 ]. Young people are especially interested in seeking help remotely, and their willingness to do so has been found to increase with the severity of their STBs, whereas their willingness to seek face-to-face help shows the opposite pattern [ 40 ]. There are very few evidence-based remote interventions, however. Torok et al. [ 49 ] performed a meta-analysis of randomized controlled trials on remote interventions for STBs and identified no more than six, of which only three were found to be effective. The effect size was small, and the effects were limited to suicidal thoughts, not behaviors. This is a major shortcoming since not a single psychological intervention to date has consistently been found to be effective in reducing both suicidal thoughts and suicidal behaviors. For example, Dialectical Behavior Therapy, Cognitive Behavior Therapy for Suicide Prevention, Attempted Suicide Short Intervention Program and Safety Planning have been found effective at reducing suicide attempts but did not change suicidal thoughts more than controls [ 3 , 7 , 16 , 31 , 39 ], whereas Collaborative Assessment and Management of Suicidality only reduced suicidal thoughts and not suicidal behaviors [ 44 ]. Hence, interventions that decrease suicidal thoughts cannot be assumed to reduce suicide attempts, and vice versa. One reason for the modest results of remote interventions to date is that most remote interventions for STBs have been unguided or minimally guided interventions, which are known to suffer from low adherence rates [ 27 ]. In most of the studies, participants completed fewer than 50% of the treatment modules [ 49 ], which might have undermined their effectiveness. The effectiveness of online interventions for STBs might therefore be improved by offering guidance, which has been found to reduce dropout and increase effectiveness in the remote treatment of other mental health issues [ 13 ]. This even makes guided interventions more cost-effective than unguided interventions, although they are naturally more expensive [ 21 ]. In addition, previous studies offered the same intervention to all participants, whereas personalizing interventions to people’s problems and personal characteristics has been found to increase adherence rates [ 1 ] and sometimes outcomes [ 5 , 23 ] in other fields. Cognitive behavioral therapy for suicide prevention (BCBT; [ 4 , 42 ]) is a personalized intervention that directly targets STBs. According to a meta-analysis, it is one of very few psychological interventions with replicated effectiveness in preventing suicide attempts [ 45 ], with no indications of any adverse effects. For example, a randomized controlled trial by Rudd et al. [ 39 ] found that participants treated with BCBT were 60% less likely to have attempted suicide within two years after ending their treatment than participants who received treatment as usual. Case reports suggest that BCBT can also be delivered online [ 36 ]. Objectives {7} This study therefore aims to evaluate the effectiveness of remotely delivered BCBT in preventing suicide attempts in a fully remote randomized controlled trial, in which it will be compared to an online self-help course that has previously been found to be effective in reducing suicidal thoughts [ 8 , 25 , 54 ]. Client satisfaction, adverse effects and the impact of both interventions on suicidal thoughts, co-occurring mental health issues and quality of life will be investigated as secondary outcomes. We hypothesize that remote BCBT will be superior to the control group at 18-month follow-up on all outcomes. Trial design {8} This is a fully remote, parallel group, randomized controlled superiority trial in which participants will be randomized with an allocation ratio of 1:1 to one of two active intervention groups. A flowchart of the study can be found in Fig. 1 . Fig. 1. Open in a new tab Flowchart of the study Methods: participants, interventions and outcomes Study setting {9} The study is fully remote and will be executed by the Healthcare Division of 113 Suicide Prevention in Amsterdam, The Netherlands. Eligibility criteria {10} People are eligible to participate in the study if they meet the following criteria: 16 years or older Currently living in the Netherlands Any type of STBs in the past 4 weeks, as indicated by a score ≥1 on the C-SSRS People who meet any of the following criteria are excluded from participation in the study: Insufficient mastery of the Dutch language Previously engaged in 113 online therapy or self-help course Currently seeing a mental health professional at least once every 3 weeks, other than a general practitioner or general practice-based nurse practitioner 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. Who will take informed consent? {26a} Participants are first informed about the study through a written summary of the participant information form on the recruitment page. After registering for the study, they are automatically emailed the full participant information form with the encouragement to read it before their first appointment and the invitation to submit any questions or concerns in advance via email or by requesting a callback. During the first appointment, a research assistant explains the purpose, procedures, and potential risks and benefits of the study, as well as participants’ rights (e.g., voluntary participation, confidentiality, right to withdraw). Participants are again presented with the digital participant information form and are explicitly invited to ask questions or express any concerns before deciding to participate. If they agree to take part, they are asked to sign a digital informed consent form. Date and time of the signing of this form are automatically logged and the form can no longer be edited afterwards. All research assistants involved in this process are psychology graduates with at least 3 months experience as a counselor in the Dutch suicide prevention helpline and are supervised by a licensed psychologist. Appointments with the research assistant take place via chat or phone, depending on the medium the participant selected for their treatment during registration. Additional consent provisions for collection and use of participant data and biological specimens {26b} Participants are asked to provide optional consent for the use of their data in future, unspecified research projects. Refusal to provide this additional consent does not affect their participation in the present study. Interventions Explanation for the choice of comparators {6b} BCBT will be compared to a semi-guided online self-help course for suicidal thoughts that was previously found to be superior to a waitlist control in three randomized controlled trials [ 8 , 25 , 54 ]. This means that the course has the highest level of evidence among all known digital interventions for suicidal thoughts and behaviors (STBs) and can therefore be considered the current gold standard—despite its small effects and the absence of demonstrated effectiveness in preventing suicide attempts or suicide. This represents an important limitation of both the field and the current study. However, according to systematic reviews, no other online intervention has shown effectiveness in this regard either [ 49 ]. While there are face-to-face interventions that have been shown to reduce suicide attempts, such an intervention was deemed unsuitable for this study because the requirement for in-person sessions would likely discourage a large proportion of the helpline’s target population from participating, thereby introducing selection bias. This is all the more important because the study is both a scientific investigation and a service evaluation. Furthermore, the self-help course used as a comparator is familiar to the counselors participating in the trial, as it has been routinely offered for several years by the healthcare department of the Dutch National Suicide Prevention Center. As such, it also reflects current usual care within the organization. The course includes exactly half as many lessons as there are sessions in BCBT. By replacing the usual written feedback on these lessons with brief feedback sessions, the number of counselor interactions can be equalized across conditions without substantially altering the structure of the intervention. Intervention description {11a} Experimental intervention Participants in the experimental condition will receive approximately 12 sessions of remotely delivered cognitive behavioral therapy for suicide prevention (BCBT; [ 4 ]), delivered by a counselor with a master’s degree in either clinical psychology or remedial education. Sessions will be scheduled twice a week whenever possible and will take place via chat or phone, depending on the participants’ preferences. BCBT consists of three phases: In Phase 1, a case conceptualization is made by performing a narrative assessment of the most dangerous suicidal crisis in the past weeks. To reduce the risk of suicide quickly, a safety plan is created and evaluated. Additionally, the counselor tries to motivate the participant to restrict access to lethal means and/or to place reminders of his or her most important reasons for living at strategic locations (e.g., attach a photo of a loved one to the car keys). In Phase 2, participants and counsellors confirm that the case conceptualization is adequate, discuss what (thus) needs to change to reduce the risk of suicide and determine which interventions they will use to achieve this. They can choose from any of the following modules or create a fully customized treatment plan in consultation with a supervisor if they think this is more appropriate: o Exploring and strengthening reasons for living o Dealing with unhelpful thoughts o Improving sleep o Behavioural activation and improving social rhythm o Relaxation and mindfulness skills o Increasing the motivation for treatment elsewhere In Phase 3, the counsellor and participant discuss which behaviours of the participant might contribute to a relapse and what might help to avoid this relapse. They then imagine using the safety plan created in phase I to cope with recent and future crises. Control intervention Participants in the control condition will be offered a semiguided online self-help course for suicidal ideation [ 54 ]. The course consists of six modules containing a theoretical section, one compulsory exercise, several optional exercises and a frequently asked questions section. Each module takes a week to complete, and participants are encouraged to practice twice a day for at least 15 min. In some of the previous studies, participants were given the option to complete the course without guidance (e.g., [ 25 ]), but participants in this study will receive feedback after each module in a conversation with their therapist to reduce the difference in the amount of attention participants in the two conditions receive. The contents of the modules are as follows: In module 1, the worrisome, repetitive aspects of suicidal thinking are outlined, and participants are taught exercises aimed at reducing worry, such as scheduling “worry times”. In module 2, participants create a safety plan and are taught several coping strategies, such as progressive muscle relaxation. Psychoeducation and exercises are aimed at promoting a more accepting stance towards unpleasant feelings. In module 3, participants learn that feelings are heavily influenced by beliefs and try to identify their own maladaptive beliefs. Module 4 describes common cognitive distortions. Exercises help participants recognize and counter these errors in their own thinking. In module 5, participants learn to challenge their maladaptive beliefs and are encouraged to formulate more helpful thoughts. In module 6, participants are prepared for future setbacks and create a relapse prevention plan. Criteria for discontinuing or modifying allocated interventions {11b} If a subject requires treatment that the study site cannot provide, such as medication or trauma-focused treatment, the attending therapist or research assistant, in consultation with a supervisor, will try to motivate the subject for treatment elsewhere, determine what treatment is appropriate and help to make the necessary arrangements. Subjects will be allowed to complete their treatment if they prefer to, but will no longer take part in the study. Subjects can leave the study at their own request at any time for any reason and without any consequences. They will be asked about the reasons for their withdrawal, but it will be emphasized that they are not obliged to provide them. Strategies to improve adherence to interventions {11c} Online interventions, including the control intervention used in this study, are known to suffer from low adherence rates [ 55 ]. The control intervention will therefore be enhanced by delivering feedback on each self-help session, which is known to improve adherence [ 27 ]. This feedback will be delivered in a live conversation with a therapist instead of through a message. Treatment adherence will be explicitly discussed with all participants at the start of the study, and participants will be reminded of each appointment through text messages sent 24 h and 1 h before the appointment. Treatment adherence will be monitored by asking therapists to complete the internet intervention Patient Adherence Scale [ 22 ] (iiPAS, Lenhard et al., 2019 after each session. Although much briefer than comparable instruments (4 items, the iiPAS has excellent psychometric properties and seems to capture treatment adherence better than common proxy measures for treatment adherence, such as the number of missed sessions or logins. To detect ruptures in the working alliance as quickly as possible, participants will be asked to fill out the Dutch version of the Session Rating Scale (SRS, [ 17 ]) after each session. The SRS possesses sufficient psychometric properties [ 26 ] and measures all three traditional aspects of the working alliance: agreement on tasks and agreement on goals and bond. In addition, the SRS asks participants to rate the overall quality of the working relationship during the session. If contact with a participant is lost, the participant’s therapist will attempt to contact the participant once by e-mail, once by text message and once by phone. Since monetary rewards have been found to improve retention in randomized controlled trials [ 14 ], participants receive a 20-euro voucher for a major Dutch online retailer after each of the three assessments, presented as a thank you rather than as a reward. They will receive this voucher regardless of whether they are still in treatment. Relevant concomitant care permitted or prohibited during the trial {11d} Participants are excluded from the study at baseline if they report receiving mental health care from a professional (other than a general practitioner or mental health nurse in primary care) more frequently than once every 3 weeks. This is to ensure that the interventions under study are not confounded by concurrent high-intensity treatment. Once enrolled, participants allocated to BCBT may not receive the semi-guided self-help course and vice versa for the entire length of the study. This restriction is necessary because both interventions are routinely offered outside of the research context at the study site, and cross-contamination could compromise the integrity of the comparison. However, participants are allowed to access other forms of mental health care outside the study, as would be typical in standard practice. Restricting access to usual care would be unethical and unrepresentative of real-world conditions. All mental health service use is systematically monitored at each assessment point. Provisions for post-trial care {30} If the attending therapist and the therapist’s supervisor believe a participant requires further treatment after the 18-month follow-up, the therapist will try to motivate the subject for treatment elsewhere, discuss what treatment is appropriate and help to make the necessary arrangements. For subjects in the control condition, this can include the experimental condition. Insurance will be provided to all participants to cover any harm suffered because of the study. Outcomes {12} Primary outcome The primary outcome of this study is the number of suicide attempts, including fatal suicide attempts, at 18-month follow-up. This timeframe was chosen because most individuals who attempt suicide do so within 18 months after the onset of suicidal ideation [ 15 , 29 , 30 ], ten [ 46 ], and participants in this study are already experiencing suicidal ideation at baseline. An 18-month follow-up period is therefore expected to capture the majority of suicide attempts. As discussed in the introduction, suicide attempts were chosen as an outcome over suicidal ideation as it appears that interventions that reduce suicidal ideation do not necessarily reduce suicide attempts and vice versa [ 3 ], de Cou, Comtois & Landes, 2019; [ 16 , 31 , 39 , 44 ], raising concerns about the validity of ideation as a proxy outcome for suicide attempts and suicide. In a similar way, it is possible that interventions that reduce suicide attempts may not necessarily reduce suicide deaths. Ideally, the effect of interventions on suicide itself would therefore also be evaluated. However, detecting differences in suicide mortality would need a much larger sample than we deemed possible for this study. Given that suicide attempts are more proximally related to suicide than ideation, constitute a serious clinical outcome in their own right, and are a necessary condition for suicide, we consider them an appropriate and meaningful primary outcome for this trial. Suicide attempts will be assessed using the suicidal behavior subscale of the Columbia Suicide Severity Rating Scale (C-SSRS; [ 34 ]), a widely used and empirically validated instrument with demonstrated convergent and divergent validity across a range of populations and settings. As people may disclose suicidal thoughts and behaviors more readily through online self-report than in face-to-face interviews, the Suicidal Ideation Attributes Scale (SIDAS [ 53 ],) will first be administered as a brief self-report screener prior to the interviewer-administered C-SSRS. In this way, we hope to combine the sensitivity of self-report, which might aid in increasing the power of the study, with the specificity of a semi-structured interview. To enable the registration of fatal suicide attempts, participants will be asked at baseline to provide contact details for someone close to them. If contact with a participant is lost during follow-up, a research assistant will reach out to this contact at the end of the study to inquire about the participant’s wellbeing. Providing a contact is not mandatory, as requiring it would likely deter a substantial number of individuals from participating. If a participant’s status cannot be determined via their contact person, Statistics Netherlands (CBS) will be consulted to verify whether the participant has died by suicide. Participants are asked to provide consent for this procedure at the start of the study. Although they will be analyzed together, fatal suicide attempts will be reported separately from non-fatal attempts to allow for their inclusion in future meta-analyses. Secondary outcomes Suicidal ideation Suicidal ideation will be measured with the suicidal ideation subscale of the C-SSRS. This subscale consists of a series of “yes” or “no” questions assessing 5 types of suicidal ideation of increasing severity, ranging from a passive death wish to active suicidal ideation with plan and intent. The research assistant assigns a score from 1 to 5 based on the most severe type of suicidal ideation endorsed by the participant. If they do not report any suicidal ideation, a score of 0 will be assigned. STB composite A total score for STB severity will be derived from the C-SSRS according to the method described by Nock et al. [ 29 , 30 ] and Cohen et al. [ 6 ]: participants who report no suicidal thoughts or behaviors will be assigned a score of 0 by the research assistant, and participants who report suicidal thoughts but not behaviors will receive a score of 1–5, depending on their rating on the suicidal ideation subscale described above. Participants who report preparatory behavior but no attempt a score of 6. Participants who report an aborted attempt a score of 7, participants who report an interrupted attempt a score of 8 and participants who report a nonlethal attempt a score of 9. Participants who made a lethal attempt will be assigned a score of 10. Treatment satisfaction Treatment satisfaction will be measured with the 8-item version of the Client Satisfaction Questionnaire (CSQ-8; [ 28 ]), a relatively brief self-report measure with good psychometric properties that has previously been used to assess client satisfaction in a wide range of services [ 24 ], including online services [ 2 ], and has been validated for online use [ 33 ]. The participants’ scores on the 8 items of the scale are summed, resulting in a score between 8 and 32, with higher values indicating greater satisfaction. Adverse effects The short version of the Negative Effects Questionnaire (NEQ; [ 37 ]) will be used to identify any adverse effects of either intervention. The NEQ investigates negative therapy experiences from the perspective of the client. It consists of 20 items covering 5 subscales: symptoms (e.g., “unpleasant memories resurfaced”), quality (e.g., “I did not always understand my therapist”), dependency (“I think that I have developed a dependency on my treatment”), stigma (e.g., “I became afraid that other people would find out about my treatment”) and hopelessness (e.g., “I started thinking that the issue I was seeking help for could not be made any better”). For each adverse effect reported, participants are asked to indicate whether they think it is attributable to their treatment. A score is derived by counting the number of adverse effects attributed to the treatment in question, meaning that higher scores indicate more adverse effects. Rasch analysis suggested that the psychometric properties of the instrument are good [ 38 ]. Quality of life The Mental Health Quality of Life Questionnaire (MHQoL; [ 52 ]) will be used to assess participants’ quality of life. The MHQoL is designed to cover the major determinants of quality of life in people with mental health issues, according to previous research: self-image, independence, mood, relationships, daily activities, physical health and the future. Participants are asked to rate their satisfaction with each of these domains on a Likert scale from 0 (“worst imaginable”) to 10 (“best imaginable”). In addition, the MHQoL contains a 10-point visual analogue scale to assess general psychological wellbeing. The test–retest reliability, internal consistency and concurrent validity of the instrument are good [ 9 ]. 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. Cooccurring mental health issues Concurrent mental health issues will be measured with the short version of the Mini International Neuropsychiatric Interview (MINI; [ 32 , 41 ]) for DSM-5. The MINI is a short clinical interview of approximately 15 min that can be used to assess a wide range of mental health issues and label them according to the 17 most common classifications of the Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM–5; [ 10 ]). Healthcare utilization Healthcare utilization will be measured with the 5-item version of the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P Mini; [ 48 ]). This short version of the questionnaire measures use of care delivered by outpatient facilities, private practices, day treatment facilities, general hospitals and psychiatric hospitals and captures 80% of the costs measured with the full TIC-P. Participant timeline {13} A flowchart of the study can be found in Fig. 1 . Sample size {14} The required sample size was estimated according to the formula provided by Twisk [ 50 ]. Estimations of the number of suicide attempts in the control group were based on the number of suicide attempts reported by Mühlmann et al. [ 25 ], who offered the control intervention used in this study to a sample from a similar population. According to the results of an RCT on offline BCBT by Rudd et al. [ 39 ], the number of suicide attempts in the experimental group was assumed to be 60% less than that in the control group. Based on these estimates, an alpha of 5% and a power of 80%, it is estimated that 145 participants are required in each group. Based on the attrition rate reported in the aforementioned study by Mühlmann et al. [ 25 ], the sample size was adjusted for 25% attrition. The sample size needed for this study is therefore estimated at 182 participants per group, 364 participants in total. Recruitment {15} Participants will be recruited through the website of 113 Suicide Prevention, the national organization for the prevention of suicide in the Netherlands. 113 operates the Dutch suicide prevention helpline and provides free and anonymous interventions to anyone in the Netherlands with STBs, including the two interventions investigated in this study. People who click the registration button for these interventions will be presented with an advertisement for the study. These services aim to reach people who are not reached by regular mental healthcare, for instance because they have negative experiences seeking help or do not want others to know about their problems. Special care was therefore taken to ensure that study procedures do not discourage participation. For example, participants are not required to provide a contact person if they prefer not to, and study staff will never contact third parties, even in cases of severe suicidality. Furthermore, all participants will receive a compensation for taking part in the study. If necessary, recruitment can be expanded to 113’s helpline, which is contacted by approximately 100.000 unique visitors per year. Assignment of interventions: allocation Sequence generation {16a} Participants will be allocated to one of the treatment conditions in a 1:1 ratio using the NIH National Cancer Institute’s Clinical Trial Randomization Tool [ 47 ], applying the Maximum Tolerated Imbalance (MTI) method, set to Bick Stick with a maximum tolerated imbalance of 3. Stratification will be performed based on participants’ preferred mode of therapist contact (i.e., chat or phone), history of suicide attempts (yes/no), and gender (male/not male, other). Implementation {16c} The randomization list will be generated by an employee of 113 Suicide Prevention who is otherwise not involved in the study and uploaded to 113’s Electronic Health Record (EHR), Brightplan, by an employee of the EHR provider. Concealment mechanism {16b} At the end of the baseline assessment, the EHR system automatically assigns participants to one of the treatment arms and presents them with an appointment scheduler to book their first session with a counsellor. Participants allocated to the control group additionally receive an automated invitation to begin the self-help course. Research assistants have no role in the allocation process and no access to the randomization sequence within the EHR. Assignment of interventions: blinding Who will be blinded {17a} This automated workflow allows the research assistant who conducts the assessments to remain blind to the treatment allocation. Participants and counsellors cannot be blinded to the treatment condition since there are obvious differences between the two interventions, and counsellors need to know which intervention to administer. Participants are blind to the study’s hypotheses, however: the rationale of the study is described to them as “to investigate the effectiveness of the online therapy and online self-help course offered by 113 suicide prevention. Procedure for unblinding if needed {17b} If necessary, unblinding is possible at any time by an administrator of the EHR, who will reveal each participant’s allocation to the researchers after all data has been gathered. Data collection and management Plans for assessment and collection of outcomes {18a} Outcomes will be measured at baseline and shortly after participants have completed their experimental or control treatment and 18 months after their inclusion in the study. Participants who have dropped out of treatment will be invited for the posttreatment assessment approximately 12 weeks after their first session with their therapist. All measurements will be conducted by research assistants with a master’s degree in psychology and at least 3 months’ experience as a counselor in the Dutch suicide prevention helpline. An overview of assessment points and measurements can be found in Table 1 . Table 1. Overview of all measures and assessment points Parameter Measure Type Baseline At each session Posttreatment Follow-up Demographics n.a Self-report x - - - History of STBs C-SSRS Interview x - - - Current STBs SIDAS+C-SSRS Screener+Interview x - x x Treatment satisfaction CSQ-8 Self-report - - x - Healthcare Utilization TIQ-P Mini Self-report x x x Adverse effects NEQ Self-report - - x x Quality of life MHQoL Self-report x - x x Co-occurring mental health issues MINI Self-report x - x x Suicidal ideation BSS-5 Self-report - x - - Working alliance SRS Self-report - x - - Treatment adherence iiPAS Clinician-report - x - - Open in a new tab Plans to promote participant retention and complete follow-up {18b} Online interventions, including the control intervention used in this study, are known to suffer from low adherence rates [ 55 ]. The control intervention will therefore be enhanced by delivering feedback on each self-help session, which is known to improve adherence [ 27 ]. This feedback will be delivered in a live conversation with a therapist instead of through a message. Treatment adherence will be explicitly discussed with all participants at the start of the study, and participants will be reminded of each appointment through text messages sent 24 h and 1 h before the appointment. Treatment adherence will be monitored by asking therapists to complete the internet intervention Patient Adherence Scale (iiPAS, Lenhard et al., [ 22 ]) after each session. Although much briefer than comparable instruments (4 items), the iiPAS has excellent psychometric properties and seems to capture treatment adherence better than common proxy measures for treatment adherence, such as the number of missed sessions or logins. To detect ruptures in the working alliance as quickly as possible, participants will be asked to fill out the Dutch version of the Session Rating Scale (SRS, [ 17 ]) after each session. The SRS possesses sufficient psychometric properties [ 26 ] and measures all three traditional aspects of the working alliance: agreement on tasks and agreement on goals and bond. In addition, the SRS asks participants to rate the overall quality of the working relationship during the session. If contact with a participant is lost, the participant’s therapist will attempt to contact the participant once by e-mail, once by text message and once by phone. Since monetary rewards have been found to improve retention in randomized controlled trials [ 14 ], participants receive a 20-euro voucher for a major Dutch online retailer after each of the three assessments, presented as a thank you rather than as a reward. They will receive this voucher regardless of whether they are still in treatment. Data management {19} All study data is entered in Brightplan, the Electronic Health Record (EHR) system of 113 Suicide Prevention, using standardized digital forms. This applies to both self-report questionnaires and scoring forms of interviews. Data is automatically copied to REDCap for storage, monitoring, and analysis. Both systems include input validation measures to ensure the validity of the data. Confidentiality {27} After providing informed consent, each participant will be assigned a unique identification code that is not derived from their name or date of birth. This code is used to pseudonymize the data stored in REDCap. Only the investigators, the research assistant, and relevant regulatory authorities will have access to the key linking identification codes to personal data. Access to both Brightplan and REDCap is restricted to authorized personnel, and all activity within these systems is automatically logged. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} N/A. Statistical methods Statistical methods for primary and secondary outcomes {20a} All the statistical analyses will be performed in R [ 35 ]. Primary outcome Intention-to-treat analysis of treatment effects over time will be performed using linear mixed modelling for the number of suicide attempts at 18-month follow-up, with time, condition and time × condition as fixed effects and therapist as a random effect to account for the fact that participants are nested within therapists. ß will be calculated as an effect size index. Secondary outcomes In the same manner, differences between the two groups in the severity of suicidal ideation, the STB composite score, treatment satisfaction, adverse effects, quality of life and the number of co-occurring mental health issues will be investigated as secondary outcomes, all measured posttreatment and at follow-up. For suicidal ideation, the STB composite, quality of life and co-occurring mental health issues, the Reliable Change Index [ 19 ] will be computed for every participant. Interim analyses {21b} No interim analyses are planned. Methods for additional analyses (e.g. subgroup analyses) {20b} No additional analyses are planned. Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} All randomised participants will be included in the primary analysis according to the intention-to-treat principle, regardless of protocol adherence. A per-protocol analysis will also be conducted, including only participants who meet all key eligibility criteria, receive the allocated intervention as planned, and complete the primary outcome assessment within the prespecified time window. The per-protocol analysis will employ the same statistical approach as described for the primary outcome analysis. Missing data will be imputed separately for each treatment condition using the MICE package in R [ 51 ]. Plans to give access to the full protocol, participant level-data and statistical code {31c} The treatment protocol will be made available free of charge through the website of 113 Suicide Prevention. After publication, a deidentified data set will be provided upon request. Oversight and monitoring Composition of the coordinating centre and trial steering committee {5d} The coordinating centre is based within the Research Department of 113 Suicide Prevention and consists of the coordinating investigator, a research assistant and a senior researcher. This team meets weekly and is responsible for the day-to-day management of the trial, including organization and monitoring of recruitment and follow-up, quality assurance and communication with participating therapists. The Trial Steering Committee (TSC) will include the Chief Investigator, coordinating investigator and co-investigators. It will meet once every one or two months. The TSC will provide strategic oversight, monitor trial conduct and adherence to the protocol, and review any proposed protocol amendments. Composition of the data monitoring committee, its role and reporting structure {21a} Both interventions under investigation have been routinely offered by the helpline for several years, and their safety and effectiveness have been documented in multiple previous studies. These studies consistently demonstrated significant reductions in suicidal thoughts and behaviours among participants, with no evidence of adverse effects associated with either intervention. Given the minimal additional risk to participants, no independent Data Monitoring Committee will be established. Oversight of participant safety and data integrity will instead be undertaken by the Trial Steering Committee and the coordinating centre. Adverse event reporting and harms {22} Adverse events will be actively monitored throughout the study using a validated instrument designed to capture a broad range of potential events. Any serious adverse events will be reported immediately to the appropriate regulatory bodies, except for suicide attempts, which constitute a predefined study outcome. Frequency and plans for auditing trial conduct {23} No formal external audits of trial conduct are planned. Trial conduct will instead be monitored regularly by the coordinating centre and the Trial Steering Committee, with oversight of adherence to the protocol, ethical approvals, and regulatory requirements. Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} Any significant modifications to the protocol will be submitted to the Research Ethics Committee for approval and communicated to all relevant stakeholders, including trial registries and participating investigators, prior to implementation. Dissemination plans {31a} The findings of this trial will be disseminated through publication in peer-reviewed journals and presentation at national and international conferences. Summary results will be posted on the trial registry within 12 months of study completion. A plain-language summary will be provided to participants who have indicated their interest in receiving study results. After publication of the results, a de-identified dataset will be provided upon request. Discussion The study presented in this protocol will investigate whether it is possible to reduce suicide attempts with remote BCBT, a brief, personalized intervention that has previously been found to reduce suicide attempts in face-to-face settings. The intervention will be delivered via chat or phone by junior counsellors from a suicide prevention helpline in the Netherlands. This study provides insights into the reach of this unique service and shows whether it is feasible to deliver such an elaborate psychological intervention via phone or chat to people with severe mental health issues from a helpline with relatively inexperienced counselors. Strengths of the study include the use of suicide attempts as an outcome measure instead of a proxy measure such as suicidal ideation, an 18-month follow-up and the ability to detect both nonfatal and fatal attempts without requiring participants to provide a contact. The study uses a sound research design, validated outcome measures and an active control condition. It is fully remote. An important limitation of the study is that participants are required to identify themselves at the start of the study, whereas the helpline usually offers remote BCBT anonymously. This might deter people who are hesitant to disclose their identity from taking part in the study and cause selection bias. Second, participants are recruited among visitors of the Dutch Suicide Prevention Helpline, who are predominantly young and female [ 20 ]. This might limit the generalizability of the study’s findings. If remote BCBT proves effective, the findings of this study will add to the evidence base of BCBT as one of very few psychological interventions with replicated effectiveness in preventing suicide attempts and provide the first evidence to date that online interventions cannot only reduce suicidal thoughts but also prevent suicidal behavior. This would pave the way for the wider dissemination of BCBT and remote BCBT, for instance from crisis teams and other helplines. Trial status Recruitment has commenced on May 5, 2024 and is expected to end on November 5, 2026 (protocol version 1.1; May 25, 2024). Supplementary Information Additional file 1. SPIRIT checklist. (39.2KB, docx) Acknowledgements The authors thank Prof. Dr. Jos W. Twisk from Amsterdam University Medical Centre for his advice on the power analysis of this study and the team from Brightplan for their technical support. Abbreviations BCBT Brief Cognitive-Behavioral Therapy for Suicide Prevention C-SSRS Columbia Suicide Severity Rating Scale SBTs Suicidal Thoughts and Behaviors SIDAS Suicidal Ideation Attributes Scale CSQ-8 Client Satisfaction Questionnaire NEQ Negative Effects Questionnaire MHQoL Mental Health Quality of Life Questionnaire MINI Mini International Neuropsychiatric Interview TIQ-P Treatment Inventory of Costs in Patients with Psychiatric Disorders MTI Maximum Tolerated Imbalance DSM-5 Diagnostic and Statistical Manual of Mental Disorders, 5th edition TSC Trial Steering Committee EHR Electronic Health Record SRS Session Rating Scale iiPAS Internet Intervention Patient Adherence Scale Authors’ contributions {31b} WJ was responsible for the conceptualization and methodology of the study, provided resources, prepared the original draft of the manuscript, contributed to the review and editing process, created visualizations, oversaw project administration, and secured funding. CB, SM, and RG contributed to the methodology, participated in the review and editing of the manuscript, provided supervision, and assisted in securing funding. Funding {4} This study is funded by the 113 Suicide Prevention Fund (grant 2023-03). The funder had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. Data availability {29} WJ, a research assistant and SM will have access to the final trial dataset. After publication, a deidentified data set will be provided upon request. After publication of the trial’s results, a deidentified data set will be provided to other researchers upon request. Declarations Ethics approval and consent to participate {24} The study was approved by the medical ethics committee of the Amsterdam University Medical Centre (2023.0775). Important protocol modifications will be immediately communicated to this board and all other relevant parties. 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[ Google Scholar ] Associated Data This section collects any data citations, data availability statements, or supplementary materials included in this article. Supplementary Materials Additional file 1. SPIRIT checklist. (39.2KB, docx) Data Availability Statement WJ, a research assistant and SM will have access to the final trial dataset. After publication, a deidentified data set will be provided upon request. After publication of the trial’s results, a deidentified data set will be provided to other researchers upon request. 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