Post Traumatic Stress Disorder PTSDNCT06953687
Shared Decision Making in PTSD Treatment
A study testing Prolonged Exposure Therapy, Cognitive Processing Therapy and Written Exposure Therapy in people with Post Traumatic Stress Disorder PTSD, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder PTSD
- What is being tested?
- Prolonged Exposure Therapy, Cognitive Processing Therapy and Written Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 May 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Carl R. Darnall Army Medical Center (CRDAMC)
Fort Hood, Texas, 76544
Marielsy Pimentel, PsyD, 254-288-6474
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Vanessa Jacoby, PhD, 254-289-3468, jacobyv@uthscsa.edu
About this study
Official title: Implementing and Evaluating a Patient-Centered PTSD Treatment Program for Military Personnel
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).
Read the detailed description
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.
- Conditions
- Post Traumatic Stress Disorder PTSD
- Being tested
- Prolonged Exposure Therapy, Cognitive Processing Therapy, Written Exposure Therapy, Shared Decision Making (SHARE)
- Keywords
- Shared Decision Making, Patient Characteristics, Patient Treatment preference, Treatment engagement, Treatment outcomes
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure TherapyBehavioural
Also called PE
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.
Cognitive Processing TherapyBehavioural
Also called CPT
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.
Written Exposure TherapyBehavioural
Also called WET
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.
Shared Decision Making (SHARE)Other
Also called SHARE
The study will use the SHARE Approach to facilitate treatment planning and decision-making. SHARE stands for:
- Seek the patient's participation
- Help the patient explore and compare treatment options
- Assess the patient's values and preferences
- Reach a decision with the patient
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure (PE) Therapy Massed | Experimental | Daily treatment sessions Monday-Friday for up to 24 sessions Receives: Behavioral: Prolonged Exposure Therapy; Other: Shared Decision Making (SHARE) |
| Prolonged Exposure (PE) Spaced | Experimental | Weekly treatment formula for up to 24 sessions Receives: Behavioral: Prolonged Exposure Therapy; Other: Shared Decision Making (SHARE) |
| Cognitive Processing Therapy (CPT) Massed | Experimental | Daily treatment sessions Monday-Friday for up to 24 sessions Receives: Behavioral: Cognitive Processing Therapy; Other: Shared Decision Making (SHARE) |
| Cognitive Processing Therapy (CPT) spaced | Experimental | Weekly treatment formula for up to 24 sessions Receives: Behavioral: Cognitive Processing Therapy; Other: Shared Decision Making (SHARE) |
| Written Exposure Therapy (WET) Massed | Experimental | Daily treatment sessions Monday-Friday for up to 24 sessions Receives: Behavioral: Written Exposure Therapy; Other: Shared Decision Making (SHARE) |
| Written Exposure Therapy (WET) Spaced | Experimental | Weekly treatment formula for up to 24 sessions Receives: Behavioral: Written Exposure Therapy; Other: Shared Decision Making (SHARE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of treatment initiation
Percentage of participants initiate and complete at least one session of evidence-based Posttraumatic Stress Disorder (PTSD) treatment
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Secondary outcomes (5)
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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start9 May 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress Disorder PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-stage randomized preference design to examine relationship between patient characteristics, treatment preferences and treatment outcomes.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Vanessa Jacoby, PhD, Principal investigator, The University of Texas Health Science Center at San AntonioAlan L Peterson, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953687
- Sponsor's protocol ID
- STUDY00001302
- Other IDs
- HT9425-23-2-0016, HT94252320018
- Status last verified
- Aug 2026
- First submitted
- 22 Apr 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Resick PA, Wachen JS, Dondanville KA, LoSavio ST, Young-McCaughan S, Yarvis JS, Pruiksma KE, Blankenship A, Jacoby V, Peterson AL, Mintz J; STRONG STAR Consortium. Variable-length Cognitive Processing Therapy for posttraumatic stress disorder in active duty military: Outcomes and predictors. Behav Res Ther. 2021 Jun;141:103846. doi: 10.1016/j.brat.2021.103846. Epub 2021 Mar 25.
PubMed 33894644Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.
PubMed 29362795Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.
PubMed 35015065
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Evaluating a Patient-Centered PTSD Treatment Program for Military Personnel
- ClinicalTrials.gov ID
- NCT06953687
- Acronym / sponsor ID
- STUDY00001302
- Conditions
- Post Traumatic Stress Disorder PTSD
- Keywords
- Shared Decision Making, Patient Characteristics, Patient Treatment preference, Treatment engagement, Treatment outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 9 May 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Two-stage randomized preference design to examine relationship between patient characteristics, treatment preferences and treatment outcomes.
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure (PE) Therapy Massed | Experimental | Behavioral: Prolonged Exposure Therapy, Other: Shared Decision Making (SHARE)Daily treatment sessions Monday-Friday for up to 24 sessions |
| Prolonged Exposure (PE) Spaced | Experimental | Behavioral: Prolonged Exposure Therapy, Other: Shared Decision Making (SHARE)Weekly treatment formula for up to 24 sessions |
| Cognitive Processing Therapy (CPT) Massed | Experimental | Behavioral: Cognitive Processing Therapy, Other: Shared Decision Making (SHARE)Daily treatment sessions Monday-Friday for up to 24 sessions |
| Cognitive Processing Therapy (CPT) spaced | Experimental | Behavioral: Cognitive Processing Therapy, Other: Shared Decision Making (SHARE)Weekly treatment formula for up to 24 sessions |
| Written Exposure Therapy (WET) Massed | Experimental | Behavioral: Written Exposure Therapy, Other: Shared Decision Making (SHARE)Daily treatment sessions Monday-Friday for up to 24 sessions |
| Written Exposure Therapy (WET) Spaced | Experimental | Behavioral: Written Exposure Therapy, Other: Shared Decision Making (SHARE)Weekly treatment formula for up to 24 sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure TherapyAlso: PEPE 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. | Behavioural | Prolonged Exposure (PE) Spaced, Prolonged Exposure (PE) Therapy Massed |
| Cognitive Processing TherapyAlso: CPTCPT 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. | Behavioural | Cognitive Processing Therapy (CPT) Massed, Cognitive Processing Therapy (CPT) spaced |
| Written Exposure TherapyAlso: WETWET 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. | Behavioural | Written Exposure Therapy (WET) Massed, Written Exposure Therapy (WET) Spaced |
| Shared Decision Making (SHARE)Also: SHAREThe 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. | Other | Cognitive Processing Therapy (CPT) Massed, Cognitive Processing Therapy (CPT) spaced, Prolonged Exposure (PE) Spaced, Prolonged Exposure (PE) Therapy Massed, Written Exposure Therapy (WET) Massed, Written Exposure Therapy (WET) Spaced |
Primary outcome
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.
5 secondary outcomes
Brief Inventory of Psycho-social Functioning
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)
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)
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)
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)
Time frame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 33894644Resick PA, Wachen JS, Dondanville KA, LoSavio ST, Young-McCaughan S, Yarvis JS, Pruiksma KE, Blankenship A, Jacoby V, Peterson AL, Mintz J; STRONG STAR Consortium. Variable-length Cognitive Processing Therapy for posttraumatic stress disorder in active duty military: Outcomes and predictors. Behav Res Ther. 2021 Jun;141:103846. doi: 10.1016/j.brat.2021.103846. Epub 2021 Mar 25.
- Background: PubMed 29362795Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.
- Background: PubMed 35015065Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanessa Jacoby, PhD principal investigator
The University of Texas Health Science Center at San Antonio
Alan L Peterson, PhD principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure Therapy, Cognitive Processing Therapy and Written Exposure Therapy in people with Post Traumatic Stress Disorder PTSD, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Jacoby, PhD (254-289-3468, jacobyv@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of treatment initiation (time frame: Baseline to Treatment Session 1 (approximately 2 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06953687, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.