NCT07574658

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
26mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2028

Last Updated

May 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

September 9, 2025

Last Update Submit

May 4, 2026

Conditions

Suicide IdeationSuicide Attempts

Keywords

SuicideSuicide preventionBrief Cognitive Behavioral Therapy (BCBT)Randomized clinical trialEvidence-based psychotherapyLow- and middle-income countries (LMICs)

Outcome Measures

Primary Outcomes (1)

  • Suicide attempt

    The primary outcome is suicide attempt.

    6 months follow-up

Secondary Outcomes (3)

  • Suicide ideation (passive and active)

    6 months follow-up

  • Depressive Symptoms

    6 months

  • Anxiety Symptoms

    6 months follow-up

Other Outcomes (6)

  • Religiosity

    6 months follow-up

  • Purpose in Life

    6 months follow-up

  • Subjective Happiness

    6 months follow-up

  • +3 more other outcomes

Study Arms (2)

Supportive Therapy

ACTIVE COMPARATOR

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.

Behavioral: Supportive Therapy

BCBT for suicide prevention

EXPERIMENTAL

BCBT 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: Brief Cognitive-Behavioral Therapy (BCBT) for Suicide Prevention

Interventions

Brief Cognitive-Behavioral Therapy (BCBT) for Suicide PreventionBEHAVIORAL

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).

Also known as: Brief Cognitive-Behavioral Therapy (BCBT), Cognitive Behavioral Therapy (CBT)
BCBT for suicide prevention
Supportive TherapyBEHAVIORAL

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.

Supportive Therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (37)

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    BACKGROUND

  • Hu, F. H., Xu, J., Jia, Y. J., Ge, M. W., Zhang, W. Q., Tang, W., Zhao, D. Y., Hu, S. Q., Du, W., Shen, W. Q., Xu, H., Zhang, W. B., & Chen, H. L. (2024). Non-pharmacological interventions for preventing suicide attempts: A systematic review and network meta-analysis. Asian Journal of Psychiatry, 93, 103913. https://doi.org/10.1016/j.ajp.2024.103913

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  • Grover, S., Avasthi, A., & Jagiwala, M. (2020). Clinical practice guidelines for practice of supportive psychotherapy. Indian Journal of Psychiatry, 62(Suppl 2), S173-S182. https://doi.org/10.4103/psychiatry.IndianJPsychiatry_768_19

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    BACKGROUND

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    BACKGROUND

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MeSH Terms

Conditions

Suicide, AttemptedSuicideSuicide Prevention

Interventions

Cognitive Behavioral TherapyPalliative Care

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student at the Institute of Psychiatr

Study Record Dates

First Submitted

September 9, 2025

First Posted

May 8, 2026

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

April 10, 2028

Study Completion (Estimated)

July 10, 2028

Last Updated

May 8, 2026

Record last verified: 2026-04