An interventional study of Prolonged Exposure Therapy and Cognitive Processing Therapy in Post Traumatic Stress Disorder PTSD, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Supportive care
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).
The primary objectives of the project are to evaluate the relationships between patient characteristics, patient treatment preferences, treatment engagement, and treatment outcomes for active duty services members engaging in a Shared Decision Making pre-intervention followed by evidence-based PTSD treatment. A secondary objective is to evaluate the impact of Shared Decision Making to match patients to evidence-based cognitive behavioral treatments for PTSD.
Aim 1: To conduct a partially randomized preference trial to examine the relationships between patient characteristics, treatment preferences, and treatment outcomes for active duty service members engaging in a Shared Decision Making pre-intervention followed by evidence-based treatment for PTSD.
Research Question 1: What are the PTSD treatment initiation rates and completion rates for active duty service members engaging in a Shared Decision Making pre-intervention prior to starting an evidence-based treatment for PTSD?
Research Question 2: Will patient characteristics (i.e., age, gender, military pay grade, racial-ethnic identity, deployment history) predict patient preference for a treatment type, session frequency, or treatment modality?
Research Question 3: Will strength of preference in a specific treatment type, session frequency, or treatment modality predict PTSD treatment initiation, treatment completion, or PTSD symptom reduction?
Aim 2: To evaluate the impact of Shared Decision Making on PTSD treatment completion and PTSD symptom reduction for active duty military personnel.
Hypothesis 1: Patients who engage in Shared Decision Making will show higher rates of treatment completion as compared to prior PTSD randomized controlled trials (RCTs) with active duty service members
Hypothesis 2: Patients who engage in Shared Decision Making will show larger reductions in PTSD symptoms from pre-to posttreatment as compared to benchmarked outcomes from prior PTSD RCTs with active duty service members. Treatment gains will be maintained over time, consistent with prior research.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily treatment sessions Monday-Friday for up to 24 sessions
Behavioral: Prolonged Exposure Therapy · Other: Shared Decision Making (SHARE)
Weekly treatment formula for up to 24 sessions
Behavioral: Prolonged Exposure Therapy · Other: Shared Decision Making (SHARE)
Daily treatment sessions Monday-Friday for up to 24 sessions
Behavioral: Cognitive Processing Therapy · Other: Shared Decision Making (SHARE)
Weekly treatment formula for up to 24 sessions
Behavioral: Cognitive Processing Therapy · Other: Shared Decision Making (SHARE)
Daily treatment sessions Monday-Friday for up to 24 sessions
Behavioral: Written Exposure Therapy · Other: Shared Decision Making (SHARE)
Weekly treatment formula for up to 24 sessions
Behavioral: Written Exposure Therapy · Other: Shared Decision Making (SHARE)
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.
Also known as: PE
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.
Also known as: CPT
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.
Also known as: WET
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.
Also known as: SHARE
Completion of treatment initiation
Percentage of participants initiate and complete at least one session of evidence-based Posttraumatic Stress Disorder (PTSD) treatment
Time frame: Baseline to Treatment Session 1 (approximately 2 weeks)
Completion of all Treatment sessions
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.
Time frame: Baseline to Posttreatment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Preference for type of treatment
Measured on a Likert Scale from 0= no preference to 10= extremely high preference
Time frame: Measured at Pre-Treatment Shared Decision-Making Session
Posttraumatic Stress Disorder Checklist (PCL-5)
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.
Time frame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Brief Inventory of Psycho-social Functioning
7-item self-report instrument measuring respondents' level of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. Respondents indicate the degree to which they had trouble in the last 30 days in each area on a 7-point scale ranging from 0 ("Not at all") to 6 ("Very much"). Scores range from 0-42 with a higher score indicating better level of psycho-social function.
Time frame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Patient Health Questionnaire 9 (PHQ-9)
9 items that assess both affective and somatic symptoms related to depression and depressive disorders; these 9 items correspond to the diagnostic criteria for Major Depressive Disorder. Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores on all items are summed to obtain a total severity score between 0-27. Scores reflect no significant depressive symptoms (0-4), mild depressive symptoms (5-9), moderate depressive symptoms (10-14), moderately severe depressive symptoms (15-19), and severe depressive symptoms (\>19)
Time frame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Generalized Anxiety Disorder 7 (GAD-7)
This is a 7-item measure that asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores on all items are summed to obtain a total severity score between 0-21. Scores reflect no significant anxiety symptoms (0-4), mild anxiety symptoms (5-9), moderate anxiety symptoms (10-14), and severe anxiety symptoms (\>15).
Time frame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Depressive Symptom Index - Suicidality Subscale (DSI-SS)
The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide occurring within the past two weeks. Scores on each item range from 0 to 3, with a total possible score from 0-12 with higher scores reflecting greater severity of suicidal ideation.
Time frame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Posttraumatic Cognitions Inventory (PTCI)
The PTCI is a 36-item ( rated on a 7-point scale: 1=totally disagree and 7=totally agree) questionnaire that was developed to determine how an individual views the trauma and its sequelae in an attempt to understand both how PTSD develops and is maintained It is comprised of three subscales (Negative Cognitions about the Self (Score range 21-147), Negative Cognitions about the World (Score range 7-49), and Self-Blame (Score range 5-35)). Items 13, 32 and 34 are experimental, so not included in the subscales) Each subscale score is summed and then divided by the number of items to provide an average. The 3 subscale averages are totaled to give a total score between 33-221. A higher score indicates greater endorsement of negative conditions.
Time frame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Plan to share: Yes — As a STRONG STAR study, presentations and publications produced as a result of this work will follow the STRONG STAR Standard Operating Procedure STRONG STAR-ADM-001-5.0. The investigators will share deidentified date with other researchers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: At completion of the study, summary results will be posted to ClinicalTrials.gov and after review and publication in a peer review journal.
Started May 2025 (actual). Primary completion is estimated for Sep 2027, 28 months after the start.
Of 73 non-industry interventional studies with no phase under Combat Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 28 months is above that.
Counting every sponsor, half of 79 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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