Clinical trial NCT06285708: Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD
Official title: Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Suicidal Ideation
Suicide, Attempted
Trauma, Psychological
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Beck Scale for Suicidal Ideation (SSI)
timeFrame: During the first 3 weeks and through one year follow up
measure: Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
timeFrame: During the first 3 weeks and through one year follow up
measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5)
timeFrame: During the first 3 weeks and through one year follow up
Secondary outcomes:
measure: Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom Measure
timeFrame: During the first 3 weeks and through one year follow up
measure: Interpersonal Needs Questionnaire (INQ) - Abbreviated
timeFrame: During the first 3 weeks and through one year follow up
measure: Beck Hopelessness Scale (BHS) - Abbreviated
timeFrame: During the first 3 weeks and through one year follow up
measure: Brief Suicide Cognitions Scale (SCS)
timeFrame: During the first 3 weeks and through one year follow up
measure: Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
timeFrame: During the first 3 weeks and through one year follow up
measure: Monetary Choice Questionnaire (MCQ)
timeFrame: During the first 3 weeks and through one year follow up
measure: Behavioral Inhibition Scale (BIS)
timeFrame: During the first 3 weeks and through one year follow up
measure: Behavioral Activation Scale (BAS)
timeFrame: During the first 3 weeks and through one year follow up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
timeFrame: During the first 3 weeks and through one year follow up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
timeFrame: During the first 3 weeks and through one year follow up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
timeFrame: During the first 3 weeks and through one year follow up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
timeFrame: During the first 3 weeks and through one year follow up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
timeFrame: During the first 3 weeks and through one year follow up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
timeFrame: During the first 3 weeks and through one year follow up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
timeFrame: During the first 3 weeks and through one year follow up
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Assistant Professor
name: Jaryd Hiser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: