Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Current diagnosis of PTSD or subthreshold PTSD; ability to speak and understand the English language; and ability to complete the informed consent process.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Prolonged exposure
BehavioralPE 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Prolonged exposure with crisis response planExperimental treatment 1 intervention
Group B: Prolonged exposure with safety planActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
During the first 3 weeks and through one year follow up2
Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
31 item self-report measure of suicidal thoughts and behavior
Time frame
During the first 3 weeks and through one year follow up3
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
Time frame
During the first 3 weeks and through one year follow upSecondary outcomes
1
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.
Time frame
During the first 3 weeks and through one year follow up2
Interpersonal Needs Questionnaire (INQ) - Abbreviated
self-report assessment of interpersonal factors (perceived burdensomeness and thwarted belongingness) that contribute to suicidal ideation.
Time frame
During the first 3 weeks and through one year follow up3
Beck Hopelessness Scale (BHS) - Abbreviated
A 5 item self-report assessment of hopelessness, range of scores is 0-10, higher scores indicate better outcome
Time frame
During the first 3 weeks and through one year follow up4
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
Time frame
During the first 3 weeks and through one year follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
United States Department of Defense
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov