Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-27 @ 4:45 AM
Study NCT ID:
NCT07238192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mCPT+CRP
Brief Summary:
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.
Detailed Description:
This study is designed to learn whether adding Crisis Response Planning (CRP), a brief, personalized strategy for managing emotional crises, to massed Cognitive Processing Therapy (CPT) can reduce suicidal thoughts and behaviors among military personnel and veterans receiving treatment for posttraumatic stress disorder (PTSD). CPT is a well-established, evidence-based psychotherapy for PTSD, and CRP is an evidence-based intervention shown to reduce suicidal ideation and suicide attempts. By combining these two approaches, this study aims to improve outcomes for individuals who are experiencing both PTSD symptoms and recent suicidal thoughts or behaviors.
We will enroll active-duty service members and veterans who meet criteria for PTSD or subthreshold PTSD and who have experienced active suicidal ideation within the past week or a suicide attempt (actual, aborted, or interrupted) within the past month. Participants will be randomly assigned to one of two treatment conditions:
1. massed CPT plus Crisis Response Planning (CRP)
2. massed CPT plus usual care suicide risk management, which involves a standard safety planning procedure.
All participants will receive 10 daily sessions of massed CPT over two consecutive weeks. The suicide-risk intervention (CRP or usual-care safety planning) is introduced during the intake session and reviewed throughout CPT treatment.
The study has three main goals:
Aim 1 is to determine whether adding CRP to CPT reduces suicide attempts and suicidal ideation more effectively than usual care safety planning. We expect that participants who receive CRP will experience larger and faster reductions in suicidal thoughts and fewer suicide attempts during follow-up.
Aim 2 is to identify early indicators of treatment response and relapse. We will examine whether early improvements in suicide-related symptoms predict changes in suicidal ideation during treatment and whether these markers help identify individuals at higher risk for suicidal behavior after treatment.
Aim 3 is to understand which parts of CRP are most helpful to participants. We will explore how often participants use CRP outside of sessions, which components they find most beneficial, and how these factors relate to reductions in suicidal thinking and behavior.
This study builds on promising preliminary findings. In earlier research conducted by this team, CRP led to faster reductions in suicidal thoughts and fewer suicide attempts than usual care risk-management procedures when paired with massed CPT. Additional analyses have shown that early reductions in suicidal ideation during PTSD treatment may be especially important for long-term recovery from both suicide risk and PTSD symptoms. However, more research is needed to confirm these results in a larger sample and to better understand the mechanisms through which CRP may improve outcomes.
Participants will complete baseline assessments, 10 massed CPT sessions, ecological momentary assessment (EMA) surveys for four weeks, optional booster sessions, and follow-up assessments at 1, 3, 6, 9, and 12 months. The study will take place at the STRONG STAR clinical offices located at the Carl R. Darnall Army Medical Center (CRDAMC) at Fort Hood. Participants may be compensated for completing study assessments, EMA surveys, and other research activities.
By studying both clinical outcomes and early markers of change, this project aims to improve suicide-prevention strategies for military personnel and veterans and provide clinicians with better tools to identify and respond to suicide risk during PTSD treatment.
We will enroll active-duty service members and veterans who meet criteria for PTSD or subthreshold PTSD and who have experienced active suicidal ideation within the past week or a suicide attempt (actual, aborted, or interrupted) within the past month. Participants will be randomly assigned to one of two treatment conditions:
1. massed CPT plus Crisis Response Planning (CRP)
2. massed CPT plus usual care suicide risk management, which involves a standard safety planning procedure.
All participants will receive 10 daily sessions of massed CPT over two consecutive weeks. The suicide-risk intervention (CRP or usual-care safety planning) is introduced during the intake session and reviewed throughout CPT treatment.
The study has three main goals:
Aim 1 is to determine whether adding CRP to CPT reduces suicide attempts and suicidal ideation more effectively than usual care safety planning. We expect that participants who receive CRP will experience larger and faster reductions in suicidal thoughts and fewer suicide attempts during follow-up.
Aim 2 is to identify early indicators of treatment response and relapse. We will examine whether early improvements in suicide-related symptoms predict changes in suicidal ideation during treatment and whether these markers help identify individuals at higher risk for suicidal behavior after treatment.
Aim 3 is to understand which parts of CRP are most helpful to participants. We will explore how often participants use CRP outside of sessions, which components they find most beneficial, and how these factors relate to reductions in suicidal thinking and behavior.
This study builds on promising preliminary findings. In earlier research conducted by this team, CRP led to faster reductions in suicidal thoughts and fewer suicide attempts than usual care risk-management procedures when paired with massed CPT. Additional analyses have shown that early reductions in suicidal ideation during PTSD treatment may be especially important for long-term recovery from both suicide risk and PTSD symptoms. However, more research is needed to confirm these results in a larger sample and to better understand the mechanisms through which CRP may improve outcomes.
Participants will complete baseline assessments, 10 massed CPT sessions, ecological momentary assessment (EMA) surveys for four weeks, optional booster sessions, and follow-up assessments at 1, 3, 6, 9, and 12 months. The study will take place at the STRONG STAR clinical offices located at the Carl R. Darnall Army Medical Center (CRDAMC) at Fort Hood. Participants may be compensated for completing study assessments, EMA surveys, and other research activities.
By studying both clinical outcomes and early markers of change, this project aims to improve suicide-prevention strategies for military personnel and veterans and provide clinicians with better tools to identify and respond to suicide risk during PTSD treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HT94252410360 | OTHER_GRANT | U.S. Army Medical Research & Development Command | View |