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NCT Number: NCT05613972

Integrated Suicide & Trauma Therapy for Suicide Risk

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1M8, Canada

Location status: Recruiting

Location contact

Molly Hyde, MSc, PhD (cand.)

CONTACT

[email protected]

416-864-6060 ext. 7844

Sakina Rizvi, PhD, RP

PRINCIPAL_INVESTIGATOR

About this study

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, 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 BSTT to alleviate suicide risk among individuals with a history of childhood trauma and current suicidality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ISTT
  • The presence of active psychosis
  • Unwilling or unable to provide informed consent

Treatment and study plan

Integrated Suicide and Trauma Therapy

Other

12-week trauma therapy for suicide risk

Primary outcomes

  1. Change in Beck Scale for Suicide Ideation (BSS) score

    Time frame: From baseline to 1 week post-therapy

    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.

  2. Feasibility and acceptability of ISTT

    Time frame: From baseline to 1 week post-therapy

    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.

Secondary outcomes

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

    Time frame: From baseline to 1-week post therapy

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

    Time frame: From baseline to 1 week post-therapy

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

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

    Time frame: From baseline to 1 week post-therapy

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksandra Lalovic, PhD,MEd,RP

CONTACT

[email protected]

416-864-6060 ext. 46483

Sakina Rizvi, PhD,MACP,RP

CONTACT

[email protected]

416-864-6060 ext. 6489

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Acronym: ISTT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 14, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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