Integrated Suicide & Trauma Therapy for Suicide Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
The presence of cognitive impairment and/or active psychosis that would limit consent or understanding of ISTT
Unwilling or unable to provide informed consent
Trial design
Design model
Single group
Treatments tested in this trial
Integrated Suicide and Trauma Therapy
Other intervention12-week trauma therapy for suicide risk
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Integrated Suicide and Trauma Therapy (BSTT)Experimental treatment 1 intervention
Trial outcomes
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-therapy2
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-therapySecondary 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 therapy2
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-therapy3
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-therapySponsors and contacts
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Source ClinicalTrials.gov