Recruiting

ISTT

Sponsor:

Unity Health Toronto

Code:

NCT05613972

Conditions

Suicide

Trauma

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Integrated Suicide and Trauma Therapy

Study Details

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

Study ID

NCT05613972

Start date

Dec 8, 2025

Status verified date

Dec, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • any psychiatric diagnosis as long as there are no impairments that limit consent or understanding of ISTT (e.g. active psychosis)
  • Ability to provide informed consent
  • Not receiving other psychotherapy concurrently
  • Ability to undergo psychotherapy in English

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Integrated Suicide and Trauma Therapy (BSTT)

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.

Interventions

Integrated Suicide and Trauma Therapy

12-week trauma therapy for suicide risk

Primary outcome measure

  • Change in Beck Scale for Suicide Ideation (BSS) score [ Time Frame: From baseline to 1 week post-therapy ]
  • Feasibility and acceptability of ISTT [ Time Frame: From baseline to 1 week post-therapy ]

Central Contacts and Locations

Central contacts

Sakina Rizvi, PhD,MACP,RP

416-864-6060rizvisa@smh.ca

Aleksandra Lalovic, PhD,MEd,RP

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

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1M8

Contacts

Molly Hyde, MSc, PhD (cand.)

416-864-6060traumatherapy@asrlife.ca

Principal Investigator:

Sakina Rizvi, PhD, RP

More Information

Sponsor

Unity Health Toronto

Last update posted

Aug 17, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-08-17.