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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators have developed an integrated suicide intervention, Brief Suicide and Trauma Therapy (BSTT). BSTT combines Brief-Skills for Safer Living (Brief-SfSL)-a promising method to enhance coping skills and reduce suicidality-with a trauma therapy component to alleviate the specific impacts of childhood trauma on suicide risk. The aim of this pilot is to test 12-weeks of BSTT to alleviate suicide risk among individuals with a history of childhood trauma and current suicidality.

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.

Is Brief Suicide & Trauma Therapy generally safe for humans?

There is limited information on the safety of behavioral health interventions like Brief Suicide & Trauma Therapy, as adverse events are often underreported in these trials. Serious adverse events such as suicide attempts are monitored, but other side effects like temporary anxiety increases are not always documented. ^{1 2 3 4 5}

How does Brief Suicide and Trauma Therapy differ from other treatments for suicide risk?

Brief Suicide and Trauma Therapy is unique because it combines elements of both suicide-specific interventions and trauma-focused therapies, addressing both immediate suicide risk and underlying trauma. This dual focus is particularly novel as traditional guidelines often recommend against trauma-focused treatments for individuals at high suicide risk, making this approach innovative in its simultaneous targeting of both issues. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Brief Suicide and Trauma Therapy for suicide risk?

Research shows that brief interventions, like those provided by the Allied Health Brief Therapies clinic, can reduce suicidal thoughts, emergency visits, and negative emotions while improving well-being in people facing a suicidal crisis. Additionally, therapies such as cognitive behavioral therapy and problem-solving therapy have been effective in reducing suicidal ideation, suggesting that brief treatments can be beneficial for those at risk. ^{6 11 12 13 14}

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

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 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]

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]

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]

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 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]

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 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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Brief and Ultra-Brief Suicide-Specific Interventions. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Impact of Allied Health Brief Therapy Clinic Interventions in Consumers in Suicidal Crisis. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Intervention for suicide attempters: A randomized controlled study. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Psychotherapy after a suicide attempt-current evidence and evaluation]. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Comparing cognitive behavior therapy, problem solving therapy, and treatment as usual in a high risk population. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Exclusion of Suicidal Participants From Randomized Controlled Trials for Posttraumatic Stress Disorder: A Meta-Analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse events of group psychotherapy in the in-patient setting - results of a naturalistic trial. [2019]

10. United States 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. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Suicide-Focused Group Therapy. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Treating Veterans at Risk for Suicide: An Examination of the Safety, Tolerability, and Outcomes of Cognitive Processing Therapy. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Addressing co-occurring suicidal thoughts and behaviors and posttraumatic stress disorder in evidence-based psychotherapies for adults: A systematic review. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Treating PTSD Within the Context of Heightened Suicide Risk. [2022]