Cognitive Behavioural Therapy for Suicidal Ideation

Overseen By Gisela Jimenez-Colon, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Bradley Hospital

Disqualifiers: Conduct disorder, Substance use, Eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a therapy approach called Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) specifically for Latinx/Hispanic youth experiencing serious suicidal thoughts or behaviors. It evaluates the effectiveness of this treatment both on its own and with the added support of a community health worker. The study will monitor the youth's symptoms and family engagement with the treatment over nine months to assess the benefits of additional support. The trial seeks Latinx/Hispanic youth who have faced a suicidal crisis in the past year and are fluent in either Spanish or English, along with their caregivers. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving mental health support for Latinx/Hispanic youth.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this treatment protocol is safe for Latinx/Hispanic youth?

Research has shown that Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) is generally manageable for participants. One study found that 63% of teens experienced fewer suicidal thoughts after six months, and 50% had fewer thoughts after twelve months. Notably, there were no suicide attempts in the SCBT-SB group between six and twelve months.

Adding a Community Health Worker (CHW) to the SCBT-SB treatment has not increased risk. CHWs provide extra support, which can enhance the treatment's effectiveness. Overall, these findings suggest that SCBT-SB, with or without additional support from a CHW, is safe for young people experiencing suicidal thoughts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) because it offers a culturally centered approach, unlike traditional cognitive-behavioral therapies that may not consider cultural nuances. This treatment stands out by integrating a community health worker (CHW) into the therapy process, providing additional support and potentially enhancing patient outcomes. By addressing both social and cognitive aspects of suicidal behavior, SCBT-SB aims to offer a more comprehensive and personalized treatment option, which could lead to more effective interventions for individuals struggling with suicidal thoughts.

What evidence suggests that this trial's treatments could be effective for suicidal ideation?

Research has shown that Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB), which participants in this trial may receive, can help reduce suicidal thoughts and actions. In a small initial study, participants who completed SCBT-SB experienced significant positive changes and a lower risk of suicide. Studies on cognitive behavioral therapy (CBT) in general have also found it effective in reducing suicidal thoughts and actions over time. Another treatment arm in this trial involves a new clinical model that combines SCBT-SB with a Community Health Worker (CHW). This approach is designed specifically for Latinx/Hispanic youth to increase participation and may improve results by offering culturally relevant support. ^{1 2 6 7 8}

Who Is on the Research Team?

Yovanska Duarte-Velez, PhD

Principal Investigator

Brown University Health

Are You a Good Fit for This Trial?

This trial is for Latinx/Hispanic youth experiencing suicidal thoughts and behaviors, along with their caregivers. Participants must identify as part of the Latinx community and be struggling with issues related to suicide or depression.

Inclusion Criteria

Latinx, defined as have been born in a Latin country or having at least one biological parent, grandparent or an ancestor that was born in a Latin country

Suicidal crisis within the past 12 months

Severe Suicidal Ideation (SI) meeting specific criteria

Exclusion Criteria

Participants with main clinical complaints of behavioral issues (e.g., conduct disorder, or substance use disorder)

Participants with main clinical complaints of a developmental issue or significant cognitive delay that may require specialized treatment adjustments

I am seeking help for an eating disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) with or without the support of a community health worker (CHW)

6 months

Regular visits as per treatment protocol

Follow-up

Participants are monitored for changes in suicidal ideation, suicide attempts, suicidal events, and depressive symptoms

3 months

Follow-up assessments at 6 and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• SCBT-SB + CHW
• Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)

Trial Overview The study tests a culturally relevant treatment called Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB). It will compare outcomes between those receiving SCBT-SB alone and those getting additional support from a community health worker (CHW) over nine months.

How Is the Trial Designed?

Group I: New Clinical Model: SCBT-SB + Community Health Worker Experimental Treatment 1 Intervention

SCBT-SB treatment with the additional support of a community health worker (CHW)

Group II: SCBT-SB (Only) Active Control 1 Intervention

A culturally centered CBT treatment protocol called Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)

Who Is Running the Clinical Trial?

Bradley Hospital

Lead Sponsor

Trials

22

Recruited

1,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06882798

A New Clinical Model for the Engagement of Latinx Youth ... SCBT-SB is a manualized psychosocial treatment protocol developed specifically with and for L/H youth with suicidal ideation and behaviors.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6424518/

Socio-Cognitive Behavioral Therapy for Suicidal Behavior with ... Outcomes of a small open pilot using the SCBT-SB showed that treatment completers had clinically significant positive changes and reductions in suicide risk ...

3. nimhd.nih.gov nimhd.nih.gov/news-events/research-spotlight/socio-cognitive-behavioral-therapy-suicidal-behaviors-shows-promise

Socio-Cognitive-Behavioral Therapy for Suicidal ... - NIMHD Suicidal ideation was reduced in the SCBT-SB group in 63% of the ... Although the results from the pilot show SCBT-SB is feasible to ...

4. rimed.org rimed.org/rimedicaljournal/2022/05/2022-05-31-suicide-jimenez-colon.pdf

Working with Latinx Youth with Suicidal Behaviors and ... The objective is to illustrate the process of addressing cultural considerations in SCBT-SB when working with L/H caregivers. Specifically, four ...

5. researchgate.net researchgate.net/figure/Socio-Cognitive-Behavioral-Treatment-for-Suicidal-Behavior-Protocol_tbl3_296475075

Socio-Cognitive Behavioral Treatment for Suicidal ... The target outcomes included suicidal ideation (SI), suicide attempts (SAs), and depressive/internalizing symptoms. Results indicated that the SCBT-SB was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11484704/

Psychological interventions for suicidal behavior in ... Recent evidence indicates that the risk of death by suicide in teenagers has increased significantly worldwide.

7. samhsa.gov samhsa.gov/mental-health/suicidal-behavior/about

About Suicide and Suicidal Behavior Suicide impacts entire communities. Each person who dies by suicide leaves behind loved ones, along with the impact of suicide and the bereavement that follows.

8. sprc.org sprc.org/resources/stanley-brown-safety-plan/

Stanley-Brown Safety Plan A brief intervention to help those experiencing self-harm and suicidal thoughts with a concrete way to mitigate risk and increase safety.