Integrated Suicide & Trauma Therapy for Suicide Risk

NCT05613972 | Recruiting

• 1 other identifier: ISTT-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have developed a novel suicide intervention, Integrated Suicide and Trauma Therapy (ISTT). ISTT 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 ISTT to alleviate suicide risk among individuals with a history of childhood trauma and current suicidality.

Conditions

Suicide; Trauma; Major Depressive Disorder

Keywords

Childhood trauma; Early life adversity; Adverse childhood experiences; Suicide intervention; Psychotherapy

Outcome Measures

Primary Outcomes (2)

• Change in Beck Scale for Suicide Ideation (BSS) score

  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 1 week post-therapy

• Feasibility and acceptability of ISTT

  Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM), in addition to a feedback 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 1 week post-therapy

Secondary Outcomes (3)

• Change in Generalized Anxiety Disorder 7-item scale (GAD-7) score

  From baseline to 1-week post therapy

• Change in Quick Inventory of Depressive Symptoms 16-item scale (QIDS) score

  From baseline to 1 week post-therapy

• Change in Difficulties in Emotion Regulation Scale 36-item scale (DERS) score

  From baseline to 1 week post-therapy

Study Arms (1)

Integrated Suicide and Trauma Therapy (BSTT)

EXPERIMENTAL

This novel suicide intervention integrates Brief Skills for Safer Learning (B-SfSL) with trauma therapy. ISTT 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: Integrated Suicide and Trauma Therapy

Interventions

Integrated Suicide and Trauma Therapy OTHER

12-week trauma therapy for suicide risk

Integrated Suicide and Trauma Therapy (BSTT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1M8, Canada

RECRUITING

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MeSH Terms

Conditions

Suicide; Wounds and Injuries; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sakina Rizvi, PhD,MACP,RP

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sakina Rizvi, PhD,MACP,RP

CONTACT

416-864-6060; rizvisa@smh.ca

Aleksandra Lalovic, PhD,MEd,RP

CONTACT

416-864-6060; Aleksandra.Lalovic@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 14, 2022
• Study Start: December 8, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)