Brief Suicide & Trauma Therapy for Suicide Risk

(BSTT Trial)

Overseen By Aleksandra Lalovic, PhD,MEd,RP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Cognitive impairment, Active psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Brief Suicide and Trauma Therapy (BSTT) to reduce suicide risk in individuals who have experienced childhood trauma and currently feel suicidal. The therapy combines coping skills with a trauma-focused approach to address the effects of past trauma. It targets individuals who have faced childhood abuse or neglect and are dealing with suicidal thoughts. Participants should not be receiving other psychotherapy and must be able to engage in therapy sessions in English. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could shape future therapies for those affected by childhood trauma and suicidal thoughts.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot be receiving other psychotherapy at the same time.

What prior data suggests that this therapy is safe?

Research has shown that Brief Suicide and Trauma Therapy (BSTT) might be safe for individuals who have experienced childhood trauma and are currently at risk of suicide. In past studies, such as one involving active-duty soldiers, similar short therapies were well-received. Participants in these studies were less likely to experience suicidal thoughts after the treatment. Another study with veterans found that brief cognitive-behavioral therapy, a structured form of talk therapy, was safe and well-received, even when concerns about suicide risk existed. These findings suggest that BSTT might also be safe, as it employs similar methods to help individuals manage their feelings and reduce the risk of suicide. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brief Suicide and Trauma Therapy (BSTT) because it integrates two innovative approaches—Brief Skills for Safer Learning (B-SfSL) and trauma therapy—into a single treatment. Unlike traditional therapies that might focus heavily on diagnosing mental health conditions, BSTT takes a non-pathologizing approach, which means it doesn’t label clients with disorders but instead emphasizes personal safety and empowerment. Additionally, BSTT prioritizes the therapeutic relationship and incorporates solution-focused concepts, offering a more personalized and supportive experience for individuals at risk of suicide. These unique features could potentially provide faster, more meaningful support compared to existing treatment options.

What evidence suggests that Brief Suicide and Trauma Therapy is effective for reducing suicide risk?

Research has shown that combining trauma therapy with suicide prevention techniques can be effective. In this trial, participants will receive Brief Suicide and Trauma Therapy (BSTT), which integrates Brief Skills for Safer Learning (B-SfSL) with trauma therapy. One study found that therapy focused on trauma, combined with suicide prevention methods, improved symptoms of PTSD (post-traumatic stress disorder) and depression, and reduced suicidal thoughts. These short-term treatments have shown promising results, with some participants experiencing an 80% lower risk of attempting suicide again after treatment. This approach aims to improve coping skills and address how childhood trauma affects suicide risk. Early findings suggest that this combined method could help lower the risk of suicide in people with trauma histories. ^{2 3 5 6 7}

Who Is on the Research Team?

Sakina Rizvi, PhD,MACP,RP

Principal Investigator

Unity Health Toronto

Are You a Good Fit for This Trial?

This trial is for individuals who can communicate in English, have any psychiatric diagnosis, and show significant suicidal thoughts measured by a specific scale. They must be able to consent to treatment, not be in other psychotherapy programs, and have experienced childhood trauma as defined by a questionnaire.

Inclusion Criteria

Beck Scale for Suicidal Ideation > 10

Presence of any psychiatric diagnosis

Ability to provide informed consent

Exclusion Criteria

I do not have any cognitive issues that would prevent me from understanding or consenting to treatment.

The presence of active psychosis

Unwilling or unable to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of Brief Suicide and Trauma Therapy (BSTT) to alleviate suicide risk

12 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in suicidal ideation, anxiety, depression, attachment security, emotion regulation, and coping strategies

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Brief Suicide and Trauma Therapy

Trial Overview The study tests Brief Suicide and Trauma Therapy (BSTT), which combines coping skills enhancement with trauma therapy aimed at reducing suicide risk due to childhood trauma. Participants will undergo this integrated intervention over a period of 12 weeks.

How Is the Trial Designed?

Group I: Brief Suicide and Trauma Therapy (BSTT) Experimental Treatment 1 Intervention

This novel suicide intervention integrates Brief Skills for Safer Learning (B-SfSL) with trauma therapy. BSTT incorporates the guiding principles of taking a non-pathologizing approach to treatment, emphasizing safety, attending to the therapeutic relationship, empowering clients, and incorporating solution-focused concepts.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Published Research Related to This Trial

Cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT) have been identified as effective psychotherapeutic treatments for individuals who have attempted suicide, based on recent Cochrane reviews and meta-analyses.

Despite the effectiveness of these therapies, the overall impact is small, and there are significant methodological issues in the research, indicating a need for better empirical support and wider dissemination of suicide-specific psychotherapy programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychotherapy after a suicide attempt-current evidence and evaluation]. Teismann, T., Gysin-Maillart, A.[2022]

In a study of 290 military veterans with PTSD, over 50% were identified as having an increased risk of suicide, yet only 1% engaged in suicidal behavior after starting cognitive processing therapy (CPT), indicating that CPT is safe and tolerable for this population.

Veterans with varying levels of suicide risk experienced similar reductions in PTSD symptoms after CPT, suggesting that trauma-focused therapy can be beneficial even for those at higher risk of suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Veterans at Risk for Suicide: An Examination of the Safety, Tolerability, and Outcomes of Cognitive Processing Therapy. Roberge, EM., Harris, JA., Weinstein, HR., et al.[2022]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

A meta-analysis of 48 randomized controlled trials (RCTs) on PTSD psychotherapy found no significant difference in treatment effects between trials that excluded participants with suicidal ideation (SI) and those that included them, indicating that SI exclusion does not notably affect outcomes.

This lack of significant impact suggests that clinical practice guidelines for PTSD treatments can be developed without the need for strict exclusion of individuals with SI, allowing for more inclusive research and potentially better treatment options for those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exclusion of Suicidal Participants From Randomized Controlled Trials for Posttraumatic Stress Disorder: A Meta-Analysis. Brooks, E., Spokas, M., Goldschmidt, D.[2022]

In a study of 180 in-patients undergoing group psychotherapy, 60-65% reported experiencing adverse events such as mood deterioration or unwanted treatment reactions, indicating that these therapies can have significant negative effects for many individuals.

The study found that while reports of unwanted treatment reactions decreased over time, they were negatively associated with symptom improvement, and 34% of patients prematurely terminated their therapy, highlighting the need to consider patient characteristics and group conditions as predictors of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of group psychotherapy in the in-patient setting - results of a naturalistic trial. Schneibel, R., Wilbertz, G., Scholz, C., et al.[2019]

The SAFE VET protocol aims to test a brief intervention that combines Safety Planning Intervention with structured follow-up to effectively reduce suicide risk among Veterans in emergency departments.

This study addresses a significant gap in evidence-based interventions for Veterans at risk of suicide, focusing on enhancing their engagement in outpatient behavioral health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and study protocol for a two-part intervention: Safety planning and structured follow-up among veterans at risk for suicide and discharged from the emergency department. Currier, GW., Brown, GK., Brenner, LA., et al.[2022]

A brief intervention and contact (BIC) program significantly reduced completed suicides among 680 suicide attempters, with an odds ratio of 35.4, indicating a strong protective effect.

The BIC program also lowered the rate of subsequent suicide attempts, with an odds ratio of 17.3, suggesting that this low-cost intervention could be an effective suicide prevention strategy in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention for suicide attempters: A randomized controlled study. Vijayakumar, L., Umamaheswari, C., Shujaath Ali, ZS., et al.[2021]

A scoping review identified 12 unique group therapies targeting suicidal thoughts and behaviors, showing that all reported reductions in suicide-related outcomes, although most studies lacked sufficient power to confirm effectiveness.

The findings suggest that suicide-focused group therapies are generally feasible and acceptable, highlighting the need for more rigorous randomized controlled trials to better assess their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide-Focused Group Therapy. Chalker, SA., Martinez Ceren, CS., Ehret, BC., et al.[2022]

The article reviews various ultra-brief and brief suicide-specific interventions, highlighting their potential to quickly stabilize individuals at risk of suicide, which is crucial given the rising suicide rates.

Several interventions, such as the Safety Planning Intervention and Cognitive Therapy for Suicide Prevention, have shown promising evidence for effectiveness, indicating a need for continued research to optimize these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief and Ultra-Brief Suicide-Specific Interventions. Stanley, B., Brodsky, B., Monahan, M.[2023]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

Cognitive behavior therapy (CBT) and problem-solving therapy (PST) both led to significant improvements in various measures related to hopelessness and suicidal ideation among suicide attempters, indicating their efficacy as treatment options.

Participants receiving CBT and PST reported higher satisfaction levels compared to those receiving treatment as usual (TAU), highlighting the potential benefits of these brief therapies in managing suicidal thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing cognitive behavior therapy, problem solving therapy, and treatment as usual in a high risk population. Stewart, CD., Quinn, A., Plever, S., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10172548/

Brief and Ultra-Brief Suicide-Specific Interventions - PMC A 2016 RCT (22), conducted by the intervention's developers, showed that participants treated with ASSIP had an 80% reduced risk of reattempting ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05613972/brief-suicide-trauma-therapy-for-suicide-risk

Brief Suicide & Trauma Therapy for Suicide Risk In the last 10 years, despite available treatments, suicide rates have not significantly decreased, and individuals who have experienced any ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826055

Telehealth Brief Cognitive Behavioral Therapy for Suicide ... The findings of this randomized clinical trial suggest that BCBT delivered via video telehealth is effective for reducing suicide attempts.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04072666

A Comparison of Brief Cognitive Behavioural Therapy ... The aim of this project is to assess if adding one of two structured suicide specific psychological interventions to a standardised clinical care approach ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666518223000074

Trauma focused psychotherapy in patients with suicidal ... Overall, studies reported symptom improvements in Posttraumatic Stress Disorder, depression, and BPD symptoms, suicidal ideation and non-suicidal self-injury, ...

6. aap.org aap.org/en/patient-care/blueprint-for-youth-suicide-prevention/strategies-for-clinical-settings-for-youth-suicide-prevention/conducting-a-brief-suicide-safety-assessment/?srsltid=AfmBOoq-D9aVLqJj98B5XquE3RIfyjeO-BqneypBKbYvGNI0MOheM6rx

Conducting a Brief Suicide Safety Assessment The brief suicide safety assessment is a way to triage patients who screen positive (non-acute/not imminent) to determine next steps.

7. academic.oup.com academic.oup.com/milmed/article/190/7-8/1629/7923186

Safety and Tolerability of a Brief Cognitive-Behavioral Therapy ... Brief CBT-CP appears to be a safe and well-tolerated treatment for Veterans with chronic noncancer pain who are also at risk for suicide.