Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
The purpose of this research is to see if Crisis Response Planning (CRP), a brief strategy designed to help people cope effectively with emotional crises, combined with Cognitive Processing Therapy (CPT), a talk treatment for posttraumatic stress disorder (PTSD), will reduce suicidal thoughts and behaviors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Active duty service member or veteran aged 18 or older eligible for military medical care.
Able to read, write, and speak English.
Meeting diagnostic criteria for PTSD or subthreshold PTSD (i.e., meeting diagnostic threshold for 3 of 4 symptom criteria within the past month) on the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
Active suicidal ideation within the past week as assessed by scoring ≥ 1 on Scale for Suicidal Ideation (SSI) item 4 (i.e., active suicidal ideation within the past month) or report an interrupted, aborted, or actual suicide attempt within the preceding month on the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R).
Disqualifiers
Inability to comprehend and complete the consent and baseline screening questionnaires.
Current suicide or homicide risk meriting crisis intervention.
Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.
Currently engaged in evidence-based psychotherapy for PTSD (e.g., Cognitive Processing Therapy, Prolonged Exposure Therapy, Written Exposure Therapy).
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Processing Therapy
BehavioralRegardless of which assignment, participants will receive 10 sessions of Cognitive Processing Therapy (CPT) delivered daily Monday through Friday over two consecutive weeks. In CPT treatment participants will complete symptom checklists and learn a variety of skills to help with symptoms of PTSD.
Treatment groups
190 Participants
are divided into 2 treatment groupsGroup A: Safety Plan (TAU)Active comparator 1 intervention
Group B: Crisis Response Plan (CRP)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PTSD Checklist for DSM-5 (PCL-5)
The PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) is a 20-item self-report measure used to assess PTSD symptom severity and monitor clinical change over time. Each item is rated on a 5-point scale (0 = Not at all to 4 = Extremely), yielding a total score ranging from 0 to 80, with higher scores indicating worse PTSD symptom severity.
Time frame
From baseline to 12-months follow up2
Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
The Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) is a structured clinical interview assessing the presence and characteristics of suicidal and nonsuicidal thoughts and behaviors. The SITBI-R does not produce a single total score; instead, each item is coded dichotomously as 0 = "No" or 1 = "Yes" to indicate the presence of a given thought or behavior. Higher item values indicate the presence of the self-injurious thought or behavior being assessed.
Time frame
Baseline to 12 months posttreatmentSecondary outcomes
1
Scale for Suicide Ideation (SSI)
The Scale for Suicide Ideation is a 21-item self-report measure of past-week or worse-points suicidal ideation. The minimum score is 0, and the maximum score is 42. Higher scores are indicative of more severe suicidal ideation.
Time frame
Baseline through 12 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
University of Vermont Medical Center
Collaborator
The University of Texas Health Science Center at San Antonio
Collaborator
C.R.Darnall Army Medical Center
Collaborator
Source ClinicalTrials.gov