Shared decision making to pick PTSD therapy for active duty military

Implementing and Evaluating a Patient-Centered PTSD Treatment Program for Military Personnel

This project will try shared decision making to match active duty service members with one of three PTSD therapies (Prolonged Exposure, Cognitive Processing Therapy, or Written Exposure Therapy) and either daily or weekly sessions to see if that improves treatment start, completion, and symptom reduction.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (other)
• Locations: 2 sites (Fort Cavazos, Texas and 1 other locations)
• Trial ID: NCT06953687 on ClinicalTrials.gov

What this trial studies

This is a partially randomized preference trial using a shared decision making (SDM) pre-intervention to match active duty service members with an evidence-based PTSD therapy and with either massed (daily) or spaced (weekly) session schedules. Participants who meet DSM-5 PTSD criteria on the CAPS-5 will engage in SDM with clinicians and then receive Prolonged Exposure, Cognitive Processing Therapy, or Written Exposure Therapy. The study examines how patient characteristics and treatment preferences relate to treatment initiation, retention, and symptom outcomes, and also evaluates the impact of SDM on matching and engagement. Key exclusions include acute suicidality/homicidality, moderate-to-severe brain injury, severe alcohol problems, and active psychosis or mania.

Who should consider this trial

Good fit: Adult active duty military members (age 18+) who meet DSM-5 PTSD criteria on the CAPS-5 and are able to participate in outpatient cognitive behavioral therapy are the ideal candidates.

Not a fit: Those with acute suicidal or homicidal risk, moderate-to-severe traumatic brain injury, severe alcohol use requiring immediate care, or active psychosis/mania are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, shared decision making could increase the number of service members who start and complete effective PTSD therapy and improve symptom outcomes.

How similar studies have performed: Prolonged Exposure, Cognitive Processing Therapy, and Written Exposure Therapy have strong evidence for treating PTSD, but using shared decision making to match patients to these options is relatively novel and has limited direct trial data.

Eligibility criteria

Inclusion Criteria:

1. Adult active duty military service members aged 18 or older.
2. Meets diagnostic criteria for PTSD based on the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS-5).

Exclusion Criteria:

1. Acute suicidality or homicidality requiring immediate intervention, such as hospitalization.
2. Moderate to severe brain injury as assessed by the History of Head Injury Form
3. Severe alcohol consumption patterns as assessed using the Alcohol Use Disorders Identification Test and warranting immediate intervention as determined by clinical judgement.
4. Experiencing active psychosis or mania as determined by scores on the Prodromal Questionnaire and Mood Disorder Questionnaire in combination with clinical judgement.

Where this trial is running

Fort Cavazos, Texas and 1 other locations

• Carl R. Darnall Army Medical Center (CRDAMC) — Fort Cavazos, Texas, United States (RECRUITING)
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (RECRUITING)

Study contacts

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

Conditions: Post Traumatic Stress Disorder PTSD, Shared Decision Making, Patient Characteristics, Patient Treatment preference, Treatment engagement, Treatment outcomes