Brief Cognitive Behavioral Therapy for Suicide Prevention in a Brazilian Sample: a Study Protocol of a Randomized Clinical Trial

Overview

The vast majority of suicides occur in low-and middle-income countries (LMICs), and evidence on effective psychotherapeutic interventions to prevent suicide that are culturally adapted to these contexts is limited. This scenario implies an urgent need for evidence-based suicide prevention strategies in Brazil. This research aims to evaluate the effectiveness of brief cognitive-behavioral therapy in preventing suicide in an outpatient setting of a Brazilian university. A randomized, controlled clinical trial with two arms, whose participants are adults who have attempted suicide or have had suicidal ideation with intent to die, will be designed. Inclusion criteria will be suicidal ideation with intent to die in the last week and/or suicide attempt in the last month. Patients will be randomly assigned to receive either a weekly 12-session supportive therapy or brief cognitive-behavioral therapy. The duration of treatment will be approximately 3 months. Both groups will have weekly individual therapy. Follow-up contact will be made 1 month and 6 months after treatment. If necessary, patients are entitled to two booster sessions during the follow-up period. The outcomes to be assessed, a priori, are suicide attempts, self-harm without suicidal intent and suicidal ideation, assessed by the Beck Scale for Suicide Ideation (BSI). Linear mixed models will be used to assess the outcomes of continuous variables, logistic regression models for categorical outcomes and survival analysis for the analysis of suicide attempts.

Brief cognitive behavioral therapy for suicide prevention in a Brazilian sample: a study protocol of a randomized clinical trial Background Suicide figures as a major public health-related outcome and as one of the main causes of premature mortality (O'Connor et al., 2023). According to World Health Organization (WHO) data, more than 720,000 deaths by suicide are registered worldwide each year (World Health Organization, n.d.). Considering the alarming numbers, WHO has set the reduction of suicide mortality as a priority in the United Nations Sustainable Development Goals (SDGs), as well as in WHO's 13th General Programme of Work 2019-2023 and in the WHO Mental Health Action Plan 2013-2022 which has been extended to 2030 (World Health Organization, 2021). WHO (2021) states that an articulated response to suicide prevention is urged as this outcome costs millions of lives and burdens suicide-exposed people, affected by those who have attempted or died by suicide (World Health Organization, 2021). Each death by suicide affects in average more than 130 people, that may further need clinician support after being exposed to suicide grief (Cerel et al., 2016). In 2019, the global age-standardized suicide rate was 9.0 per 100,000 population and in Brazil the suicide rate was 6.7 per 100,000 inhabitants (World Health Organization, 2021). In 2021, a significant majority of suicides - 73% - occurred in low-and-middle-income countries (LMICs) (World Health Organization, n.d). This data explains the urgent need for effective suicide prevention strategies in LMICs, including Brazil, where suicide is a growing public health concern. Despite the Brazilian rate being inferior to the global age-standardized rate in 2019, other alarming data highlights the urgency of addressing this public health issue in Brazil. Regardless of the 36% global reduction in the numbers of suicides from 2000 to 2019 (Damiano et al., 2024) some countries, such as Brazil, still face the challenge to address rising numbers. The Americas region has demonstrated a 17% increase in the same period and Brazil figures as one of the countries with the most significant rise (43%) (World Health Organization, 2021). According to the most recent epidemiological bulletin released by the Brazilian government, from 2000 to 2021, there was a 42% increase in the suicide mortality rate, from 5.2 to 7.5 per 100,000 inhabitants (Brasil, Ministério da Saúde, Secretaria de Vigilância em Saúde e Ambiente, 2024). Brief Cognitive Behavioral Therapy CBT for suicide prevention protocols are designed to help high-risk individuals to identify patient-specific factors that trigger and intensify suicidal thoughts and behaviors, as well as to develop effective coping strategies when dealing with stressors and problems that activate the suicidal mode (Mann et al., 2021; Bryan \& Rudd, 2018). In BCBT, in order to reach those goals, treatment is composed by three main phases, as follows: Emotional Regulation and Crisis Management, Targeting Belief Systems Related to Suicide and Relapse Prevention (Bryan \& Rudd, 2018). See table 2. Phase 1 2 3 Sessions 1-5 6-10 11-12 Therapeutic component Emotional Regulation and Crisis Management Targeting Belief Systems Related to Suicide Relapse Prevention Techniques Crisis Response Plan; Means restriction counseling; Sleep stimulus control; Relaxation skills training; Mindfulness skills training; Reasons for living list; Survival kitk. ABC Worksheet ; Challenging Questions Worksheet; Problematic Patterns of Thinking Worksheet; Activity planning; Coping cards. Relapse prevention task. Table 2: The structure and components of BCBT (Bryan \& Rudd, 2018). The first phase focuses on developing effective strategies for regulating intense emotions and managing crise s in an adaptive manner (Bryan \& Rudd, 2018). During this stage, the objective is to assist the patient in identifying emotional triggers and acquiring mindfulness techniques to promote assertive responses to stressful situations. The development of an individualized action plan to address critical moments with greater emotional control is considered to be essential for therapeutic progress (Bryan \& Rudd, 2018). The second phase centers on identifying and modifying the negative and distorted thought patterns that underlie suicidal ideation. Through cognitive restructuring, the goal is to foster a more realistic and adaptive view of the self and the future, while enhancing emotional resilience. Addressing belief systems related to suicide is a critical component of the therapeutic process, as these beliefs are often linked to suicidal behavior (Bryan \& Rudd, 2018). The final phase emphasizes relapse prevention, focusing on identifying risk factors that may trigger the return of suicidal thoughts. Personalized preventive strategies will be developed, including strengthening social support networks, continuous practice of coping skills, and creating a detailed contingency plan to handle potential future adversities. The aim is to equip the patient with robust tools to maintain mental health and well-being in the long term, thereby reducing the likelihood of recurrent suicidal crises (Bryan et al., 2024). Supportive psychotherapy Concerning control treatment characteristics in suicidology, approximately 60% of the Randomized Controlled Trials across nearly 50 years of research had their active treatment condition compared to active control conditions, such as psychotherapy suicidality (Fox et al., 2020), however, the chosen psychotherapy approach as a comparator was not specified in this analysis. There has been a historical debate between researchers and clinicians that search for the understanding of what makes psychotherapy work. This debate could be summarized in the conflict existing among two main groups: those who believe that the therapy's efficacy depends solely on the common factors and the other group that defends the insertion of the specific factors (Wampold, 2015). Common factors refer to the elements that can be found in different psychotherapeutic approaches and are believed to contribute to the effectiveness of therapy, regardless of specific techniques derived from the philosophical and conceptual basis. These factors include elements such as; the therapeutic alliance, empathy, positive regard, and the client's expectations of therapy, among others (Norcross \& Lambert, 2011). Specific factors, on the other hand, according to Norcross \& Lambert (2011), can be defined as the techniques and interventions unique to particular therapeutic approaches and designed to address specific goals concerning psychological issues. For example, one of the instruments developed by CBT is the Dysfunctional Thought Record, and its specific goal is to help patients to identify and restructure their dysfunctional thoughts. According to CBT's postulates, by doing so, patients can better understand the connection between their thoughts, emotions, and behaviors, leading to more adaptive ways of thinking that allows them to feel better and develop better coping strategies. While most psychotherapies incorporate common factors alongside specific factors, Supportive Therapy (ST) is a type of psychotherapy that heavily relies on common factors. It focuses on building a strong therapeutic alliance, providing empathy, reassurance, and encouragement, and enhancing the client's strengths and coping mechanisms (Grover et al., 2020). Unlike more structured approaches like CBT or psychodynamic therapy, supportive therapy is less focused on specific techniques derived by specific theoretical approaches and more on providing emotional support and fostering a positive therapeutic relationship. By choosing ST as a control group, to compare its intervention with BCBT, we can also contribute to the literature that investigates the predictors of outcome in psychotherapy, specifically for suicide prevention. Despite CBT being a treatment approach with strong empirical support for various conditions, the evidence base for affirming which processes of the psychotherapy are responsible for the most relevant changes in outcome is insufficient (Wilhelm et al., 2019). Considering the difference between BCBT and ST, this nondirective treatment that aims to help patients coping with psychological challenges, emphasizing common factors, our goal is to compare both interventions. To enhance the ST treatment credibility, a supportive psychotherapy manual and a clinical practice guideline will be used (Pinsker, 2002; Grover et al., 2020). Project aims and hypotheses The aim is to investigate whether this brief evidence-based suicide prevention focused psychological treatment for clinical use, that has been shown effective in the United States of America, according to two Randomized Controlled Trials (Brown et al., 2005, Rudd et al., 2015), could also be effective for a Brazilian sample. To evaluate whether BCBT could effectively prevent further suicide deaths and attempts in a Brazilian University's outpatient setting, the project's main goal is to develop a methodologically robust Randomized Clinical Trial that sheds light on this possible suicide prevention clinical intervention, to address this urgent public health issue. By analyzing these intervention outcomes, we could better define treatment strategies that not only reduce the risk of subsequent suicide attempts, but also optimize the use of human and financial resources in clinical and hospital settings to prevent suicide, suicidal ideation and attempts that could be replicated to other LMICs. Hypotheses * The BCBT group will be less likely to make a suicide attempt during follow-up period, considering the superiority hypothesis sustained by previous RCTs; * Patients allocated in BCBT group will not show significantly decreased in anxious and depressive symptoms, compared to patients randomized to the control group treatment condition; * Validate variables that represent risk factors for suicide, considering some baseline variables predict a better response to BCBT treatment. Methods We propose a 6 months 2-arm randomized controlled trial of BCBT compared to a supportive therapy. BCBT\'s efficacy is well supported, however, the most relevant RCT was composed of a north American military sample (Rudd et al.,2015). Therefore, we anticipate BCBT to be more effective at preventing suicide attempts than the comparator intervention, but we would like to verify its efficacy with a Brazilian sample. Design Study setting Institute of Psychiatry of the Hospital das Clínicas, Faculty of Medicine, University of São Paulo is the selected study site for this randomized controlled trial. Eligibility criteria Study participants meet inclusion criteria if they are (1) Between the ages of 18-65; (2) Treatment-seeking status in outpatient mental health and/ or inpatient psychiatry discharge; (3) Report current (within the past week) suicide ideation (e.g., score greater than 2 on the Scale for Suicide Ideation) and/or a suicide attempt within the past month (e.g., as assessed by the Beck Scale for Suicide Ideation (BSI); (4) Able to understand and speak Portuguese; (5) Able to complete the informed consent process. Interventions Training, Supervision and monitoring of study clinicians Two clinicians will be assigned to provide both groups' treatments. Trainings will consist of sessions with didactic instruction, live supervised role plays with feedback, assigned reading materials, and supervision throughout the process. The main reference will be the BCBT manual, elaborated by Rudd \& Bryan (2018), that contains clinical practice guidelines. To enhance the treatment credibility, fidelity checklists provided by will be used and checked upon supervision by the researchers. Outcomes The primary outcome is suicide attempt. To assess the efficacy of BCBT on reducing suicide attempts, the results on the self-report version of the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R; Fox et al., 2020) will be considered. Secondary outcomes will be suicide ideation (passive and active), nonsuicidal self-injury, anxiety, and depressive symptoms. Outcomes will be assessed using the Beck Scale for Suicide Ideation (BSI), Columbia Suicide Self-Injury Scale, Deliberate Self-Harm Inventory (DSHI-s), GAD-7 and PHQ-9. Sample Size For the proposed superiority hypothesis, an intent-to-treat analysis will be used to manage missing data. Assuming an 80% power, a 5% significance level (α = 0.05), and a 25% attrition rate based on previous trials, the sample size was calculated with the following parameters: To achieve a high probability of detecting a true effect on suicide-related outcomes, the power was set at 80%. A 5% significance level indicates a 5% risk of Type I error, or falsely concluding there is a difference when none exists. Based on prior research, including randomized controlled trials focused on suicide prevention interventions, the anticipated difference in suicide attempts between groups is estimated to reflect a small to moderate effect size of d = 0.38. This estimate is informed by studies on cognitive-behavioral and crisis-response interventions for suicide risk reduction (Bryan et al., 2017; Bryan et al., 2018; Bryan et al., 2022). Considering that suicide attempts are measured as a binary outcome and based on prior findings where a reduction in suicide attempts ranged from 10% to 15% in intervention groups compared to control groups, the sample size was calculated for a two-tailed hypothesis test. Using the assumption that approximately half of the sample might have a history of suicide attempts at baseline, a correlation of r = 0.1 among repeated measures (across 6 assessments), and a within-between interaction (group\*time), the study is powered to detect a minimum effect size of d = 0.38. Accounting for a 25% attrition rate, approximately 75 participants per group (total n = 150) would be required to achieve the desired power and significance to ensure that the study remains adequately powered after accounting for missing data. The study is thus designed to detect a clinically significant reduction in suicide attempts, with a small to moderate effect size, across the study period for two equal-sized independent samples. This approach ensures that the sample size is sufficient to draw reliable conclusions regarding the efficacy of the intervention on the primary outcome of suicide attempts.