Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD
- Conditions
- Suicide, AttemptedPTSDSuicidal IdeationTrauma, Psychological
- Registration Number
- NCT06285708
- Lead Sponsor
- Ohio State University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Current diagnosis of PTSD or subthreshold PTSD; ability to speak and understand the English language; and ability to complete the informed consent process.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Beck Scale for Suicidal Ideation (SSI) 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) 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) During the first 3 weeks and through one year follow up 31 item self-report measure of suicidal thoughts and behavior
- Secondary Outcome Measures
Name Time Method 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 transdiagnostic measure of current mental health symptomatology. It is an adult measure that consists of 23 questions that assess 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use.
Beck Hopelessness Scale (BHS) - Abbreviated During the first 3 weeks and through one year follow up A 5 item self-report assessment of hopelessness, range of scores is 0-10, higher scores indicate better outcome
Behavioral Inhibition Scale (BIS) During the first 3 weeks and through one year follow up a 7 item self-report assessment of punishment sensitivity, range 0-28, higher scores indicate worse outcome
Behavioral Activation Scale (BAS) During the first 3 weeks and through one year follow up a 13 item self-report assessment of reward sensitivity, range 0-52, higher scores indicate worse outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Measures During the first 3 weeks and through one year follow up a 5 item self-report assessment of pain, range of scores 5-25, higher scores indicates worse outcome
Brief Suicide Cognitions Scale (SCS) During the first 3 weeks and through one year follow up 6 item self-report assessment of thoughts related to suicidal ideation, range of scores is 0-30, higher score indicates worse outcome
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) During the first 3 weeks and through one year follow up self-report assessment of emotion regulation.
Monetary Choice Questionnaire (MCQ) During the first 3 weeks and through one year follow up a self-report assessment of impulsivity
Interpersonal Needs Questionnaire (INQ) - Abbreviated During the first 3 weeks and through one year follow up self-report assessment of interpersonal factors (perceived burdensomeness and thwarted belongingness) that contribute to suicidal ideation.
Trial Locations
- Locations (1)
The Ohio State University
🇺🇸Columbus, Ohio, United States
The Ohio State University🇺🇸Columbus, Ohio, United StatesJaryd HiserContact614-814-0163jaryd.hiser@osumc.eduJustin Baker, Ph.D.Sub Investigator