Brief Suicide & Trauma Therapy for Suicide Risk

Major Depressive Disorder Clinical Trial

— BSTT  

Official title:

Using Brief Suicide and Trauma Therapy to Reduce Suicide Risk Among Adults With a History of Childhood Trauma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05613972
• Other study ID #: BSTT-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: January 2027

Study information

• Verified date: November 2023
• Source: Unity Health Toronto
• Contact: Sakina Rizvi, PhD,MACP,RP
• Phone: 416-864-6060
• Email: rizvisa[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In the last 10 years, despite available treatments, suicide rates have not significantly decreased, and individuals who have experienced any type of childhood maltreatment are at increased odds for suicide attempt. Effective suicide prevention requires learning skills to cope with suicidality in addition to addressing the antecedent factors that contribute to suicide risk. In the context of those with childhood trauma and suicidality, addressing antecedent factors may require treatments that target symptoms associated with developmental trauma. Thus, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Beck Scale for Suicidal Ideation > 10
• Presence of childhood trauma defined by a minimum moderate score on any of the Childhood Trauma Questionnaire subscales (emotional abuse, physical, abuse, sexual abuse, emotional neglect, and physical neglect
• Presence of any psychiatric diagnosis
• Ability to provide informed consent
• Not receiving other psychotherapy concurrently
• Ability to undergo psychotherapy in English

Exclusion Criteria:

• The presence of cognitive impairment that would limit consent or understanding of BSTT
• The presence of active psychosis
• Unwilling or unable to provide informed consent

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Psychotherapy
• Suicide
• Trauma
• Wounds and Injuries

Intervention

Other:
• Brief Suicide and Trauma Therapy
12-week trauma therapy

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (48)

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in suicidal ideation using Beck Scale for Suicide Ideation	Beck Scale for Suicide Ideation is a 21-item self-report scale that quantifies suicidal ideation. Items are scored 0 to 2 and yield a total score ranging from 0 to 38. Higher scores reflect greater severity of suicidal ideation.	From baseline to 3 months post-intervention
Secondary	Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)	The GAD-7 is a brief 7-item self-report scale measuring anxiety symptoms. Total scores range from 0 to 21, with higher scores reflecting more severe anxiety.	From baseline to 3 months post-intervention
Secondary	Feasibility of BSTT	Feasibility and Acceptability survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the BSTT intervention.	From baseline to 12-weeks. Also re-assessed at 3 months post-intervention
Secondary	Change in depression symptoms using the Quick Inventory of Depressive Symptoms 16-item scale (QIDS	The QIDS is a 16-item validated depression scale. Total scores range from 0-27, with higher scores reflecting more severe depression.	From baseline to 3 months post-intervention
Secondary	Change in attachment security using the Experience in Close Relationships 12-item scale (ECR)	The ECR is a validated 12-item scale to assess adult attachment style. The ECR is comprised of 2 subscales measuring attachment avoidance and attachment anxiety, where higher scores are reflective of greater attachment difficulties. The ECR is often analyzed by percentile.	From baseline to 3 months post-intervention
Secondary	Change in emotion regulation using the Difficulties in Emotion Regulation Scale 36-item scale (DERS)	The DERS is a 36-item validated scale measuring six aspects of emotion regulation. The DERS is comprised of 6 subscales, where higher scores are reflective of greater difficulties in emotion regulation. The DERS is often analyzed by percentile.	From baseline to 3 months post-intervention
Secondary	Change in coping strategies using the Brief-Coping Orientation to Problems Experienced (Brief-COPE)	The Brief-COPE is a 28-item scale to assess the frequency of using specific coping strategies. It is comprised of 14 2-item subscales to assess use of different coping mechanisms. Some of the subscales are related to avoidant coping and some are related to approach coping. Higher scores for the avoidant scales suggest poorer coping strategies, while higher scores on the approach scales suggest positive coping strategies.	From baseline to 3 months post-intervention