Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD

NCT ID: NCT07238192

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-08-31

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.

Conditions

Posttraumatic Stress Disorder (PTSD); Suicidal Ideation; Suicide Attempt

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safety Plan (TAU)

Participants assigned to this arm will receive Safety Planning Treatment as Usual (TAU), a brief, structured intervention commonly used by mental health professionals to help individuals identify warning signs, coping strategies, and sources of support to reduce suicide risk.

Group Type: ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type: BEHAVIORAL

Regardless 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.

Crisis Response Plan (CRP)

Participants assigned to this arm will receive Crisis Response Planning (CRP), a structured intervention designed to help individuals identify and manage suicidal thoughts and behaviors through a collaborative, personalized plan. CRP uses a procedural format distinct from standard safety planning.

Group Type: EXPERIMENTAL

Cognitive Processing Therapy

Intervention Type: BEHAVIORAL

Regardless 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.

Interventions

Cognitive Processing Therapy

Regardless 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Active duty service member or veteran aged 18 or older eligible for military medical care.

2. Able to read, write, and speak English.

3. 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).

4. 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).

5. Regular use of an iPhone or Android smartphone.

Exclusion Criteria

1. Inability to comprehend and complete the consent and baseline screening questionnaires.

2. Current suicide or homicide risk meriting crisis intervention.

3. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.

4. Currently engaged in evidence-based psychotherapy for PTSD (e.g., Cognitive Processing Therapy, Prolonged Exposure Therapy, Written Exposure Therapy).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont Medical Center

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

C.R.Darnall Army Medical Center

FED

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Christina Bauder

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig J Bryan

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Central Contacts

C. Rosie Bauder, PhD, MPH

Role: CONTACT

rosie.bauder@osumc.edu

614-814-0119

Anna Crouser, MSW

Role: CONTACT

anna.crouser@osumc.edu

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

HT94252410360

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HT94252410360

Identifier Type: -

Identifier Source: org_study_id