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Clinical Trials/NCT06285708
NCT06285708
Recruiting
Not Applicable

Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

Ohio State University1 site in 1 country100 target enrollmentFebruary 26, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
Ohio State University
Enrollment
100
Locations
1
Primary Endpoint
Beck Scale for Suicidal Ideation (SSI)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.

Detailed Description

Posttraumatic stress disorder (PTSD) is associated with a host of functional problems and negative outcomes, including occupational and marital dissatisfaction, violence, alcohol and substance abuse, and suicide. Cognitive behavioral treatments tend to be the most highly efficacious treatments for PTSD. Prolonged Exposure (PE) therapy is a manualized cognitive behavioral therapy consisting of imaginal exposure followed by processing thoughts and feelings related to the imaginal experience; in-vivo exposure, psychoeducation, and controlled breathing training. Preliminary evidence suggests that PE is associated with significant suicidal ideation (SI) reductions. Enhancing PE with procedures that have been shown to significantly reduce suicidal thoughts and behaviors could serve to further reduce suicide risk during and after treatment completion. The long-term goal of this project is to prevent suicides among individuals diagnosed with PTSD by integrating trauma-focused therapies with suicide-focused interventions. The primary objective of this pilot project is to test the efficacy of PE when enhanced with a crisis response plan utilizing self-report, behavioral, and ecological assessment methods to compare treatment effects.

Registry
clinicaltrials.gov
Start Date
February 26, 2024
End Date
January 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Current diagnosis of PTSD or subthreshold PTSD; ability to speak and understand the English language; and ability to complete the informed consent process.

Exclusion Criteria

  • Substance use disorder requiring medical management; imminent suicide risk warranting inpatient hospitalization or suicide-focused treatment; and impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania).

Outcomes

Primary Outcomes

Beck Scale for Suicidal Ideation (SSI)

Time Frame: During the first 3 weeks and through one year follow up

19 item self-report assessment of suicidal ideation, range of scores is 0-57, higher score indicates higher suicidal ideation

PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5)

Time Frame: During the first 3 weeks and through one year follow up

20 item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. range is 0-80, higher score indicates higher PTSD symptoms

Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)

Time Frame: During the first 3 weeks and through one year follow up

31 item self-report measure of suicidal thoughts and behavior

Secondary Outcomes

  • Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom Measure(During the first 3 weeks and through one year follow up)
  • Beck Hopelessness Scale (BHS) - Abbreviated(During the first 3 weeks and through one year follow up)
  • Behavioral Inhibition Scale (BIS)(During the first 3 weeks and through one year follow up)
  • Behavioral Activation Scale (BAS)(During the first 3 weeks and through one year follow up)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Measures(During the first 3 weeks and through one year follow up)
  • Interpersonal Needs Questionnaire (INQ) - Abbreviated(During the first 3 weeks and through one year follow up)
  • Brief Suicide Cognitions Scale (SCS)(During the first 3 weeks and through one year follow up)
  • Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)(During the first 3 weeks and through one year follow up)
  • Monetary Choice Questionnaire (MCQ)(During the first 3 weeks and through one year follow up)

Study Sites (1)

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