Shared Decision Making in PTSD Treatment

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).

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder PTSD
• Intervention / Treatment: Behavioral: Prolonged Exposure Therapy; Other: Shared Decision Making (SHARE); Behavioral: Cognitive Processing Therapy; Behavioral: Written Exposure Therapy

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa Jacoby, PhD; Phone Number: 254-289-3468; Email: jacobyv@uthscsa.edu
• Study Contact Backup: Name: Alan L Peterson, PhD; Phone Number: 210-562-6700; Email: petersona3@uthscsa.edu

Study Locations

• United States
  • Texas
    • Fort Cavazos, Texas, United States, 76544
      • Recruiting
      • Carl R. Darnall Army Medical Center (CRDAMC)
      • Contact: Rodney Merkley, PsyD; Phone Number: 254-553-6854
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center at San Antonio
      • Contact: Vanessa Jacoby, PhD; Phone Number: 254-289-3468; Email: jacobyv@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolonged Exposure (PE) Therapy Massed; Daily treatment sessions Monday-Friday for up to 24 sessions	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.; Other Names: PE; Other: Shared Decision Making (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.; Other Names: SHARE
Experimental: Prolonged Exposure (PE) Spaced; Weekly treatment formula for up to 24 sessions	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.; Other Names: PE; Other: Shared Decision Making (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.; Other Names: SHARE
Experimental: Cognitive Processing Therapy (CPT) Massed; Daily treatment sessions Monday-Friday for up to 24 sessions	Other: Shared Decision Making (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.; Other Names: SHARE; 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.; Other Names: CPT
Experimental: Cognitive Processing Therapy (CPT) spaced; Weekly treatment formula for up to 24 sessions	Other: Shared Decision Making (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.; Other Names: SHARE; 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.; Other Names: CPT
Experimental: Written Exposure Therapy (WET) Massed; Daily treatment sessions Monday-Friday for up to 24 sessions	Other: Shared Decision Making (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.; Other Names: SHARE; 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 Names: WET
Experimental: Written Exposure Therapy (WET) Spaced; Weekly treatment formula for up to 24 sessions	Other: Shared Decision Making (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.; Other Names: SHARE; 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 Names: WET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of treatment initiation	Percentage of participants initiate and complete at least one session of evidence-based Posttraumatic Stress Disorder (PTSD) treatment	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.	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 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.	Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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).	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.	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.	Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Vanessa Jacoby, PhD, The University of Texas Health Science Center at San Antonio; Principal Investigator: Alan L Peterson, PhD, The University of Texas Health Science Center at San Antonio

Publications and helpful links

General Publications

• Sloan 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.
• 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.
• Foa 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Shared Decision Making; Treatment outcomes; Treatment engagement; Patient Characteristics; Patient Treatment preference
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: STUDY00001302; HT9425-23-2-0016 (Other Grant/Funding Number: Department of Defense); HT94252320018 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No