NCT06953687 · The University of Texas Health Science Center at San Antonio
Shared Decision Making in PTSD Treatment
What this study is about
The purpose of this research study is to learn about how Shared Decision Making, when used to decide treatment, impacts treatment engagement, retention, and outcomes for active duty military personnel seeking treatment for posttraumatic stress disorder (PTSD).
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The purpose of this research study is to learn about how Shared Decision Making, when used to decide treatment, impacts treatment engagement, retention, and outcomes for active duty military personnel seeking treatment for posttraumatic stress disorder (PTSD). Shared Decision Making between the service member and the therapists will be used to match patients to 1 of 3 different types of therapy for PTSD: (1) Prolonged Exposure (PE) therapy, (2) Cognitive Processing Therapy (CPT), or (3) Written Exposure Therapy (WET) in 1 of 2 different frequencies: (1) massed (daily) or (2) spaced (weekly).
Interventions
BEHAVIORAL
Prolonged Exposure Therapy
PE is a cognitive-behavioral treatment for PTSD that is typically delivered in ten 90-minute sessions . For the current study using a variable length approach, participants may complete up to 24 sessions. Based on emotional processing theory PE addresses trauma-related avoidance of thoughts, behaviors, and situations, as well as unhelpful beliefs about oneself, others, and the world that were learned as a result of trauma.
BEHAVIORAL
Cognitive Processing Therapy
CPT is a 12-session, cognitive behavioral PTSD treatment typically delivered in 60-minute sessions that can be personalized to include fewer or additional sessions. For the current study using a variable length approach, participants may complete up to 24 sessions. CPT is based in cognitive theory and posits that impeded recovery following trauma occurs due to unhelpful and unrealistic beliefs that may develop after trauma, leading to chronic anger, guilt, shame, and avoidance of trauma reminders. During CPT, patients learn about PTSD symptoms, impeded recovery and cognitive theory, and the connection between trauma-based thoughts and feelings.
BEHAVIORAL
Written Exposure Therapy
WET is a cognitive behavioral therapy for PTSD that typically consists of 5 weekly 50-minute sessions. For the current study using a variable length approach, participants may complete up to 7 sessions. WET is based on an extinction and emotional processing treatment model. First, patients learn about PTSD and the role of avoidance in maintaining PTSD symptoms. Next, patients are guided to write about their trauma for 30 minutes and afterwards, the therapist briefly checks in with the patient. This procedure is followed for the next 4 sessions, with guidance to first write about the trauma, and in later sessions to write about consequences of the trauma and the patient's current meaning of their lives. The goals of WET are to assist the patient in emotionally processing the event and reduce avoidance of trauma-related thoughts and memories, which facilities recovery.
OTHER
Shared Decision Making (SHARE)
The study will use the SHARE Approach to facilitate treatment planning and decision-making. SHARE stands for: 1. Seek the patient's participation 2. Help the patient explore and compare treatment options 3. Assess the patient's values and preferences 4. Reach a decision with the patient 5. Evaluate the patient's decision The Shared Decision Making Patient Preference Checklist will be used to determine the participant's preference for type of treatment, frequency of treatment sessions, and treatment delivery modality. Step 5 also includes following up with the patient and making changes if something it not working well for the patient.
Primary outcome measures
Completion of treatment initiation
Time frame: Baseline to Treatment Session 1 (approximately 2 weeks)
Percentage of participants initiate and complete at least one session of evidence-based Posttraumatic Stress Disorder (PTSD) treatment
Completion of all Treatment sessions
Time frame: Baseline to Posttreatment (between 2 months and 7 months, depending on treatment selected and speed of progress)
The percentage of participants who complete all manualized protocol sessions (i.e., 10 PE sessions, 12 CPT sessions, or 5 WET sessions) or (2) complete treatment early because they have achieved their treatment goals. This will be defined as achieving a 10 point reduction in on the PCL-5 and scoring below the diagnostic cutoff (a PCL- 5 score of ≤ 30), as well as the therapist and patient agreeing that treatment relevant goals have been met.
Preference for type of treatment
Time frame: Measured at Pre-Treatment Shared Decision-Making Session
Measured on a Likert Scale from 0= no preference to 10= extremely high preference
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
The PCL-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms in the past month on a scale from "0 = not at all" to "4 = extremely. Scores range from 0-80 with a higher score indicating more severe PTSD.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult active duty military service members aged 18 or older.
- 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
- Acute suicidality or homicidality requiring immediate intervention, such as hospitalization.
- Moderate to severe brain injury as assessed by the History of Head Injury Form
- Severe alcohol consumption patterns as assessed using the Alcohol Use Disorders Identification Test and warranting immediate intervention as determined by clinical judgement.
- Experiencing active psychosis or mania as determined by scores on the Prodromal Questionnaire and Mood Disorder Questionnaire in combination with clinical judgement.
Where
- Fort Cavazos, Texas
- San Antonio, Texas
Collaborators
United States Department of Defense
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2025 · Source of record for eligibility and locations