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

NCT07574658 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-08

No results posted yet for this study

Summary

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.

Conditions

  • Suicide Ideation
  • Suicide Attempts

Interventions

BEHAVIORAL

Brief Cognitive-Behavioral Therapy (BCBT) for Suicide Prevention

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).

BEHAVIORAL

Supportive Therapy

Arm 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.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-10
Primary Completion
2028-04-10
Completion
2028-07-10

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07574658 on ClinicalTrials.gov