Recruiting

PTSD Treatment Strategies

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07176273

Conditions

Posttraumatic Stress Disorder

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Modular Cognitive Processing Therapy

Modular Prolonged Exposure Therapy

Step Down Treatment

Digital Interventions

Cognitive Processing Therapy (CPT)

Study Details

Brief summary:

By doing this research project, the investigators hope to learn which strategies work best to help veterans who are not benefiting from their first PTSD treatment or not completing between-session homework assignments regularly that might improve treatment response. The investigators also want to learn how best to match the right type and amount of treatment to each individual veteran. By conducting this research project, they hope to:

  • See if trying a different treatment strategy for veterans not responding to their first PTSD treatment would be more helpful
  • See if sending text message prompts between sessions encourages more completion of between-session homework

Conditions

Posttraumatic Stress Disorder

PTSD

Study ID

NCT07176273

Start date

Dec 12, 2025

Status verified date

Dec, 2025

Completion date

Aug 14, 2028

Anticipated

Primary completion date

May 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Veterans eligible for PE and CPT at the participating PTSD treatment-providing clinic who are
2. At least 18 years or older
3. Score ≥ 31 on the PCL-5 secondary to a Criterion A traumatic event
4. Own a mobile device that can be used for the therapy companion mobile app (Prolonged Exposure (PE) coach or Cognitive Processing Therapy (CPT) coach).

Exclusion Criteria:

1. Acute suicide risk requiring clinical intervention
2. Need for detoxification
3. Unmanaged psychosis or bipolar disorder
4. Severe cognitive impairment that makes it unlikely that participants can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
5. Current or past 12-month engagement in PE or CPT.

Study Design

Enrollment

302 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Early CPT Non-Responders Switch (Group A)

Early NON-RESPONDERS to CPT will SWITCH to PE

active comparator: Early CPT Non-Responders Modular (Group B)

Early NON-RESPONDERS to CPT will transition to MODULAR CPT

active comparator: Early CPT Responders Continue (Group C)

Early RESPONDERS to CPT will CONTINUE in their CPT treatment

active comparator: Early CPT Responders Step Down (Group D)

Early RESPONDERS to CPT will STEP DOWN to self-managed CPT

active comparator: Early PE Non-Responsers Switch (Group E)

Early NON-RESPONDERS to PE will SWITCH to CPT

active comparator: Early PE Non-Responders Modular (Group F)

Early NON-RESPONDERS to PE will transition to MODULAR PE

active comparator: Early PE Responders Continue (Group G)

Early RESPONDERS will CONTINUE in their PE treatment

active comparator: Early PE Responders Step Down (Group H)

Early RESPONDERS to PE will STEP DOWN to self-managed PE

Interventions

Modular Cognitive Processing Therapy

CPT is a first-line treatment for PTSD that includes the following core elements: (a) identification of "stuck points" in thinking that interfere with recovery and (b) using Socratic questioning and a series of Contains the same core elements of CPT, but content is repackaged into modules instead of sessions so that clinicians can select and dose treatment elements according to patient need. Modular CPT contains the same core elements of CPT, but content is repackaged into modules instead of sessions so that clinicians can select and dose treatment elements according to patient need.

Modular Prolonged Exposure Therapy

PE is a first-line treatment for PTSD that includes the following core elements: (a) in vivo exposure and (b) imaginal exposure to the trauma memory. Modular PE is comprised of the same elements of standard PE, but clinicians select and dose modules (i.e., imaginal exposure, in vivo exposure) based on individual patient need.

Step Down Treatment

Self-managed treatment will involve receiving a self-help version of the remaining treatment materials and ongoing use of the intervention companion app (CPT Coach or PE Coach).

Digital Interventions

The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).

Cognitive Processing Therapy (CPT)

CPT is a first-line treatment for PTSD that includes the following core elements: (a) identification of "stuck points" in thinking that interfere with recovery and (b) using Socratic questioning and a series of progressive worksheets to examine stuck points, develop balanced beliefs, and facilitate the experience of natural emotions.

Prolonged Exposure (PE)

PE is a first-line treatment for PTSD that includes the following core elements: (a) in vivo exposure and (b) imaginal exposure to the trauma memory. In imaginal exposure, participants repeatedly, systematically approach their trauma memory and related thoughts and feelings. In in vivo exposure, participants repeatedly, systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma.

Primary outcome measure

  • Posttraumatic Stress Disorder Checklist (PCL-5) [ Time Frame: 10 weeks, 20 weeks and 9 months ]

Central Contacts and Locations

Central contacts

Stefanie LoSavio, PhD

210-562-6700losavio@uthscsa.edu

Rebecca Sripada, PhD

734-222-7432Rebecca.sripada@va.gov

Locations

Augusta VA

Recruiting

Augusta, Georgia, United States, 30904

Contacts

J. Richard Monroe

734-222-7432vhaannadapt@va.gov

Ann Arbor VA

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Rebecca Sripada, PhD

734-222-7432vhaannadapt@va.gov

Salt Lake City VA

Recruiting

Salt Lake City, Utah, United States, 84148

Contacts

Erika Roberge

734-222-7432vhaannadapt@va.gov

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • Veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-12-19.