Adaptive, personalized PTSD care for veterans

Changing the Treatment Course: Clinical Trial of Sequenced Interventions to Optimize Treatment for Veterans With PTSD

This program will try different therapy sequences plus optional text-message homework reminders to see if switching treatments or sending prompts helps veterans with PTSD who aren't improving or are missing between-session homework.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 302 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (Academic / other)
• Locations: 4 sites (Augusta, Georgia and 3 other locations)
• Trial ID: NCT07176273 on ClinicalTrials.gov

What this trial studies

This interventional project uses a Hybrid Experimental Design with multiple, sequential randomizations to combine therapist-delivered and digital interventions on short and long timescales. Participants receive modular versions of Cognitive Processing Therapy or Prolonged Exposure, with options for stepped-down care and digital supports including app companions and text prompts. The design tests different sequences and combinations to identify which approaches improve response and homework completion for veterans who do not respond to initial PTSD treatment. Treatment is delivered within routine VA care settings across several sites to maximize real-world relevance and support implementable, personalized treatment rules.

Who should consider this trial

Good fit: Veterans aged 18 or older who are eligible for PE or CPT at a participating VA clinic, have a PCL-5 score of 31 or higher related to a Criterion A trauma, own a mobile device for the therapy app, and have not received PE or CPT in the past 12 months are ideal candidates.

Not a fit: Patients with acute suicide risk requiring immediate intervention, need for detoxification, unmanaged psychosis or bipolar disorder, severe cognitive impairment that limits participation, or those without a compatible mobile device are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could help veterans get the right PTSD therapy sooner and improve symptoms by tailoring treatment pathways and adding simple digital reminders to boost homework completion.

How similar studies have performed: CPT and PE are established first-line PTSD treatments and some prior work suggests reminders can improve homework adherence, but combining modular PE/CPT with multi-stage adaptive sequencing and digital prompts is a relatively novel approach.

Eligibility criteria

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.

Where this trial is running

Augusta, Georgia and 3 other locations

• Augusta VA — Augusta, Georgia, United States (Recruiting)
• Ann Arbor VA — Ann Arbor, Michigan, United States (Recruiting)
• Battle Creek VA — Battle Creek, Michigan, United States (Not_yet_recruiting)
• Salt Lake City VA — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Stefanie LoSavio, PhD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Stefanie LoSavio, PhD

Conditions Posttraumatic Stress Disorder; PTSD; Veterans