ClinicalTrials.gg
RecruitingNCT05613972ISTTUpdated Aug 17, 2026

Integrated Suicide & Trauma Therapy for Suicide Risk

An interventional study of Integrated Suicide and Trauma Therapy in Suicide, Trauma and Major Depressive Disorder, sponsored by Unity Health Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Primary conditionSuicide(the registry's first term)UnverifiedIs this wrong?Suicide is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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, 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.

02

Conditions studied

  • Suicide
  • Trauma
  • Major Depressive Disorder

Browse trials for

Keywords

  • Childhood trauma
  • Early life adversity
  • Adverse childhood experiences
  • Suicide intervention
  • Psychotherapy
03

In context

Suicide Unverified

607 studies on the registry are indexed under Suicide; 162 are open to participants now.

This study's planned enrollment of 20 is below the median of 104 across 490 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Compared within Suicide, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Not receiving other psychotherapy concurrently
  • Ability to undergo psychotherapy in English

Exclusion criteria

Exclusion Criteria:

  • The presence of cognitive impairment and/or active psychosis that would limit consent or understanding of ISTT
  • Unwilling or unable to provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study 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.

    Other: Integrated Suicide and Trauma Therapy

Interventions

  • OtherIntegrated Suicide and Trauma Therapy

    12-week trauma therapy for suicide risk

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline to 1 week post-therapy

  2. 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.

    Time frame: From baseline to 1 week post-therapy

Secondary outcomes

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

    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.

    Time frame: From baseline to 1-week post therapy

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

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

    Time frame: From baseline to 1 week post-therapy

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

    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.

    Time frame: From baseline to 1 week post-therapy

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

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Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05613972
Responsible party
Sponsor
First posted
Nov 14, 2022
Start date
Dec 8, 2025
Primary completion
Apr 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Aug 17, 2026

Study contacts

Sakina Rizvi, PhD,MACP,RP
Contact
rizvisa@smh.ca
416-864-6060 ext. 6489
Aleksandra Lalovic, PhD,MEd,RP
Contact
Aleksandra.Lalovic@unityhealth.to
416-864-6060 ext. 46483
Sakina Rizvi, PhD,MACP,RP
principal investigator · Unity Health Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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