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Recruiting NCT05613972

Integrated Suicide & Trauma Therapy for Suicide Risk

No phase Interventional Suicide Trauma Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Integrated Suicide and Trauma Therapy.
Who it may be relevant to
Registry conditions: Suicide, Trauma, Major Depressive Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Other Integrated Suicide and Trauma Therapy
    12-week trauma therapy for suicide risk

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Change in Generalized Anxiety Disorder 7-item scale (GAD-7) score [Time frame: From baseline to 1-week post therapy]
  • Change in Quick Inventory of Depressive Symptoms 16-item scale (QIDS) score [Time frame: From baseline to 1 week post-therapy]
  • Change in Difficulties in Emotion Regulation Scale 36-item scale (DERS) score [Time frame: From baseline to 1 week post-therapy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • St. Michael's Hospital — Toronto

Publications

  • Alloy LB, Abramson LY, Smith JM, Gibb BE, Neeren AM. Role of parenting and maltreatment histories in unipolar and bipolar mood disorders: mediation by cognitive vulnerability to depression. Clin Child Fam Psychol Rev. 2006 Mar;9(1):23-64. doi: 10.1007/s10567-006-0002-4. PMID 16718583
  • Angelakis I, Gillespie EL, Panagioti M. Childhood maltreatment and adult suicidality: a comprehensive systematic review with meta-analysis. Psychol Med. 2019 May;49(7):1057-1078. doi: 10.1017/S0033291718003823. Epub 2019 Jan 4. PMID 30608046
  • Bergmans Y, Links PS. Reducing potential risk factors for suicide-related behavior with a group intervention for clients with recurrent suicide-related behavior. Ann Clin Psychiatry. 2009 Jan-Mar;21(1):17-25. PMID 19239829
  • Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0. PMID 12615092
  • Berube A, Turgeon J, Blais C, Fiset D. Emotion Recognition in Adults With a History of Childhood Maltreatment: A Systematic Review. Trauma Violence Abuse. 2023 Jan;24(1):278-294. doi: 10.1177/15248380211029403. Epub 2021 Jul 9. PMID 34238064
  • Bremness A, Polzin W. Commentary: Developmental Trauma Disorder: A Missed Opportunity in DSM V. J Can Acad Child Adolesc Psychiatry. 2014 May;23(2):142-5. No abstract available. PMID 24872830
  • Briggs S, Netuveli G, Gould N, Gkaravella A, Gluckman NS, Kangogyere P, Farr R, Goldblatt MJ, Lindner R. The effectiveness of psychoanalytic/psychodynamic psychotherapy for reducing suicide attempts and self-harm: systematic review and meta-analysis. Br J Psychiatry. 2019 Jun;214(6):320-328. doi: 10.1192/bjp.2019.33. Epub 2019 Feb 28. PMID 30816079
  • Brom D, Stokar Y, Lawi C, Nuriel-Porat V, Ziv Y, Lerner K, Ross G. Somatic Experiencing for Posttraumatic Stress Disorder: A Randomized Controlled Outcome Study. J Trauma Stress. 2017 Jun;30(3):304-312. doi: 10.1002/jts.22189. Epub 2017 Jun 6. PMID 28585761

Identifiers

NCT: NCT05613972 · ISTT-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗