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

NCT07238192 | Recruiting

• 1 other identifier: HT94252410360
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

PTSD; Cognitive Processing Therapy; military; suicide; Crisis Response Planning

Outcome Measures

Primary Outcomes (2)

• 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.

  From baseline to 12-months follow up

• 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.

  Baseline to 12 months posttreatment

Secondary Outcomes (1)

• Scale for Suicide Ideation (SSI)

  Baseline through 12 months follow-up

Study Arms (2)

Safety Plan (TAU)

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Processing Therapy

Crisis Response Plan (CRP)

EXPERIMENTAL

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.

Behavioral: Cognitive Processing Therapy

Interventions

Cognitive Processing Therapy 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); Safety Plan (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Regular use of an iPhone or Android smartphone.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: collaborator
• C.R.Darnall Army Medical Center: collaborator
• Ohio State University: lead
• University of Vermont Medical Center: collaborator

Study Sites (1)

Carl R. Darnall Army Medical Center

Fort Hood, Texas, 76544-9800, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Suicidal Ideation; Suicide, Attempted; Suicide

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Craig J Bryan

  University of Vermont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

C. Rosie Bauder, PhD, MPH

CONTACT

614-814-0119; rosie.bauder@osumc.edu

Anna Crouser, MSW

CONTACT

anna.crouser@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 20, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 24, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)