BSTT: Brief Suicide & Trauma Therapy for Suicide Risk

Sponsor
Unity Health Toronto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05613972
Collaborator
(none)
20
1
1
34.1
0.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Brief Suicide and Trauma Therapy
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Using Brief Suicide and Trauma Therapy to Reduce Suicide Risk Among Adults With a History of Childhood Trauma
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brief Suicide and Trauma Therapy (BSTT)

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.

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

Outcome Measures

Primary Outcome Measures

  1. Change in suicidal ideation using Beck Scale for Suicide Ideation [From baseline to 3 months post-intervention]

    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.

Secondary Outcome Measures

  1. Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7) [From baseline to 3 months post-intervention]

    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.

  2. Feasibility of BSTT [From baseline to 12-weeks. Also re-assessed at 3 months post-intervention]

    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.

  3. Change in depression symptoms using the Quick Inventory of Depressive Symptoms 16-item scale (QIDS [From baseline to 3 months post-intervention]

    The QIDS is a 16-item validated depression scale. Total scores range from 0-27, with higher scores reflecting more severe depression.

  4. Change in attachment security using the Experience in Close Relationships 12-item scale (ECR) [From baseline to 3 months post-intervention]

    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.

  5. Change in emotion regulation using the Difficulties in Emotion Regulation Scale 36-item scale (DERS) [From baseline to 3 months post-intervention]

    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.

  6. Change in coping strategies using the Brief-Coping Orientation to Problems Experienced (Brief-COPE) [From baseline to 3 months post-intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Michael's Hospital Toronto Ontario Canada M5B 1M8

Sponsors and Collaborators

  • Unity Health Toronto

Investigators

  • Principal Investigator: Sakina Rizvi, PhD,MACP,RP, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sakina Rizvi, Principal Investigator, Unity Health Toronto
ClinicalTrials.gov Identifier:
NCT05613972
Other Study ID Numbers:
  • BSTT-01
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sakina Rizvi, Principal Investigator, Unity Health Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2022