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Behavioral Intervention

Prolonged exposure with crisis response plan for Post-Traumatic Stress Disorder

N/A
Recruiting
Led By Jaryd Hiser, Ph.D.
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current diagnosis of PTSD or subthreshold PTSD
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the first 3 weeks and through one year follow up
Awards & highlights

Study Summary

"This trial aims to reduce suicidal thoughts and behaviors in individuals with PTSD. They will test the effectiveness of combining prolonged exposure therapy with a crisis response plan, compared to prolonged exposure therapy alone, for reducing suicide

Who is the study for?
This trial is for individuals who are seeking treatment for PTSD and have suicidal thoughts or behaviors. Participants should be interested in a therapy called prolonged exposure (PE) and must not currently be receiving other specific psychological treatments.Check my eligibility
What is being tested?
The study tests the effectiveness of combining Prolonged Exposure therapy with a Crisis Response Plan (CRP) versus just PE with self-guided care, to see which is better at reducing suicidal thoughts and attempts in people with PTSD.See study design
What are the potential side effects?
While the document doesn't list side effects, typical ones from psychological therapies like PE may include temporary increases in distress, emotional discomfort, and recalling traumatic memories.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PTSD or have symptoms of PTSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the first 3 weeks and through one year follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the first 3 weeks and through one year follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Beck Scale for Suicidal Ideation (SSI)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5)
Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
Secondary outcome measures
Beck Hopelessness Scale (BHS) - Abbreviated
Behavioral Activation Scale (BAS)
Behavioral Inhibition Scale (BIS)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged exposure with crisis response planExperimental Treatment1 Intervention
In the enhanced prolonged exposure condition, participants will complete a CRP instead of a safety plan. The CRP is another recommended standard care practice with suicidal patients that includes many of the same elements as the safety plan (i.e., warning signs, self-management strategies, sources of social support, crisis services), but is created collaboratively by the patient with active input of their clinician rather than being self-guided. The CRP also includes a section focused on the participant's reasons for living, an addition that has been shown to increase positive emotional states (e.g., hope, optimism) and lead to faster reductions in suicidal intent. The CRP will be administered during the first therapy session.
Group II: Prolonged exposure with safety planActive Control1 Intervention
In the standard prolonged exposure condition, participants will complete a safety plan, a procedure that includes personal warning signs for a suicidal crisis, self-management strategies, sources of social support, and contact information for professional resources and crisis services within the participant's local community, as well as the National Suicide Prevention Lifeline phone number. As a recommended standard care practice with suicidal patients, the combination of PE and safety plan represents treatment as usual. The safety plan will be administered during the first therapy session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prolonged exposure
2012
N/A
~270

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
505,520 Total Patients Enrolled
Jaryd Hiser, Ph.D.Principal InvestigatorAssistant Professor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals actively involved in this clinical investigation?

"Affirmative, the details on clinicaltrials.gov indicate that this medical research study is actively inviting volunteers. The trial was posted for the first time on February 1st, 2024 and underwent its most recent revision on February 22nd, 2024. Enrollment of approximately a hundred participants will take place at one designated site."

Answered by AI

Is the enrollment for this medical study currently open?

"As per clinicaltrials.gov, this research study is actively seeking eligible participants. It was initially listed on 2/1/2024 and last revised on 2/22/2024."

Answered by AI

What are the anticipated results that researchers hope to achieve through conducting this study?

"The primary objective of this clinical investigation is to assess suicidal ideation using the Beck Scale within a 1-year period, monitored from the initial 3 weeks. Secondary measures encompass evaluations with the abbreviated Beck Hopelessness Scale (BHS), assessing hopelessness on a scale of 0-10 where higher scores suggest better outcomes. Additionally, assessments include the Behavioral Inhibition Scale (BIS) measuring punishment sensitivity and ranging from 0-28, where higher scores indicate less favorable outcomes; also included is the Behavioral Activation Scale (BAS) gauging reward sensitivity on a scale of 0-52, with elevated scores indicating subopt"

Answered by AI

Who else is applying?

What site did they apply to?
The Ohio State University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD
2024. "Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06285708.
~67 spots leftby Jul 2025
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