About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Brief Cognitive-Behavioral Therapy (BCBT) for Suicide Prevention
BehavioralCBT 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).
Supportive Therapy
BehavioralArm Description: 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.
Treatment groups
Trial outcomes
Primary outcomes
Suicide attempt
The primary outcome is suicide attempt.
Secondary outcomes
Suicide ideation (passive and active)
Secondary outcomes include suicidal ideation that will be assessed using the Beck Scale for Suicide Ideation (BSI).
Depressive Symptoms
The BDI-II is a 21-item self-report inventory assessing depressive symptom severity over the previous two weeks. Items cover cognitive, affective, and somatic features of depression, scored from 0-3, with total scores reflecting severity levels. It is one of the most extensively validated measures of depression and is widely used in both research and clinical practice (Beck, Steer, \& Brown, 1996). The Brazilian Portuguese version was translated and validated by Gomes-Oliveira et al. (2012), who reported strong internal consistency (α = 0.89) and robust convergent validity, supporting its clinical and research applicability in Brazil.
Anxiety Symptoms
The Generalized Anxiety Disorder-7 (GAD-7) is a widely used self-report measure designed to screen for generalized anxiety disorder and assess the severity of anxiety symptoms (Spitzer et al., 2006). Developed by Spitzer and colleagues (2006), this seven-item scale evaluates key aspects of anxiety, including feelings of nervousness, inability to control worry, and physical symptoms such as restlessness and irritability. The GAD-7 has demonstrated excellent internal consistency (Cronbach's alpha = 0.92) and strong construct validity, making it a reliable tool in both clinical and non-clinical populations. In Brazil, the GAD-7 was validated by Sousa et al. (2015), who found the instrument to be effective in capturing anxiety symptoms with strong psychometric properties, thus allowing for its application in diverse settings, including primary care and specialized mental health services (Sousa et al., 2015).
Other outcomes
Religiosity
The Duke University Religion Index (DUREL) is a brief 5-item instrument measuring three components of religiosity: organizational religious activity, non-organizational religious activity, and intrinsic religiosity. It was designed for epidemiological research and has demonstrated solid reliability and validity across diverse cultural contexts. (Koenig \& Büssing, 2010). The Brazilian Portuguese version was translated and validated by Taunay et al. (2012).
Purpose in Life
The Purpose in Life Test (PIL) is a 20-item self-report measure based on logotherapy designed to evaluate perceived meaning and purpose in life (Crumbaugh \& Maholick, 1964). Brazilian Portuguese adaptations exist and have been utilized in local research; however, large-scale psychometric validation studies remain limited. The Brazilian Portuguese adaptation of the Purpose in Life Test (PIL) has been investigated in Brazilian samples, for example, by Nascimento \& Dias (2019) and Câmara \& Strelhow (2023).
Subjective Happiness
The Subjective Happiness Scale (SHS) is a 4-item measure that assesses global subjective well-being through self-comparisons and theoretical descriptors of happiness (Lyubomirsky \& Lepper, 1999). The scale has demonstrated robust psychometric properties internationally. Brazilian adaptations have shown adequate reliability and validity in community samples.
Quality of life
The SF-12 is a 12-item abbreviated assessment of health-related quality of life, derived from the SF-36, which produces physical and mental component summary scores (Ware, Kosinski, \& Keller, 1996). The Brazilian Portuguese version of the SF-12 was translated, adapted, and psychometrically validated by Silveira et al. (2013), demonstrating adequate reliability and validity in a population-based sample.
Locations
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