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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06285708
Other study ID # 2023B0193
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date January 2026

Study information

Verified date February 2024
Source Ohio State University
Contact Jaryd Hiser, Ph.D.
Phone 614-814-0163
Email jaryd.hiser@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2026
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

Behavioral:
Prolonged exposure
PE therapy is a manualized cognitive behavioral therapy consisting of imaginal exposure (repeated recounting of the most disturbing traumatic memory) followed by processing thoughts and feelings related to the imaginal experience; in-vivo exposure (approaching trauma-related situations); psychoeducation about PTSD; and controlled breathing training. Between sessions, participants listen to audio recordings of the imaginal recounting daily and complete in-vivo exercises. Typically, PE is delivered weekly for 10-12, 90-minutes sessions. For this study, participants will complete daily 60-minute sessions for 10 consecutive weekdays during a 2-week period.

Locations

Country Name City State
United States The Ohio State University Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Beck Scale for Suicidal Ideation (SSI) 19 item self-report assessment of suicidal ideation, range of scores is 0-57, higher score indicates higher suicidal ideation During the first 3 weeks and through one year follow up
Primary Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) 31 item self-report measure of suicidal thoughts and behavior During the first 3 weeks and through one year follow up
Primary PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) 20 item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. range is 0-80, higher score indicates higher PTSD symptoms During the first 3 weeks and through one year follow up
Secondary Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom Measure 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. During the first 3 weeks and through one year follow up
Secondary Interpersonal Needs Questionnaire (INQ) - Abbreviated self-report assessment of interpersonal factors (perceived burdensomeness and thwarted belongingness) that contribute to suicidal ideation. During the first 3 weeks and through one year follow up
Secondary Beck Hopelessness Scale (BHS) - Abbreviated A 5 item self-report assessment of hopelessness, range of scores is 0-10, higher scores indicate better outcome During the first 3 weeks and through one year follow up
Secondary Brief Suicide Cognitions Scale (SCS) 6 item self-report assessment of thoughts related to suicidal ideation, range of scores is 0-30, higher score indicates worse outcome During the first 3 weeks and through one year follow up
Secondary Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) self-report assessment of emotion regulation. During the first 3 weeks and through one year follow up
Secondary Monetary Choice Questionnaire (MCQ) a self-report assessment of impulsivity During the first 3 weeks and through one year follow up
Secondary Behavioral Inhibition Scale (BIS) a 7 item self-report assessment of punishment sensitivity, range 0-28, higher scores indicate worse outcome During the first 3 weeks and through one year follow up
Secondary Behavioral Activation Scale (BAS) a 13 item self-report assessment of reward sensitivity, range 0-52, higher scores indicate worse outcome During the first 3 weeks and through one year follow up
Secondary Patient-Reported Outcomes Measurement Information System (PROMIS) Measures a 4 item self-report assessment of depression, range of scores 4-20, higher score indicates worse outcome During the first 3 weeks and through one year follow up
Secondary Patient-Reported Outcomes Measurement Information System (PROMIS) Measures a 4 item self-report assessment of anxiety, range of scores 4-20, higher scores indicate worse outcome During the first 3 weeks and through one year follow up
Secondary Patient-Reported Outcomes Measurement Information System (PROMIS) Measures a 4 item self-report assessment of social activity, range of scores is 4-20, higher score indicates worse outcome During the first 3 weeks and through one year follow up
Secondary Patient-Reported Outcomes Measurement Information System (PROMIS) Measures a 4 item self-report assessment of fatigue, range of scores is 4-20, higher scores indicate worse outcome During the first 3 weeks and through one year follow up
Secondary Patient-Reported Outcomes Measurement Information System (PROMIS) Measures a 4 item self-report assessment of sleep, range of scores is 4-20, higher scores indicate worse outcome During the first 3 weeks and through one year follow up
Secondary Patient-Reported Outcomes Measurement Information System (PROMIS) Measures a 4 item self-report assessment of physical function, range of scores is 4-20, higher score indicates better outcome During the first 3 weeks and through one year follow up
Secondary Patient-Reported Outcomes Measurement Information System (PROMIS) Measures a 5 item self-report assessment of pain, range of scores 5-25, higher scores indicates worse outcome During the first 3 weeks and through one year follow up
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