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Shared Decision Making in PTSD Treatment

NCT06953687 · The University of Texas Health Science Center at San Antonio
In plain English

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Official title
Implementing and Evaluating a Patient-Centered PTSD Treatment Program for Military Personnel
About this study
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.
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.
Study design
Enrollment target: 200 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-05-09
Estimated completion: 2028-09
Last updated: 2025-06-22
Interventions
Behavioral: Prolonged Exposure TherapyBehavioral: Cognitive Processing TherapyBehavioral: Written Exposure TherapyOther: Shared Decision Making (SHARE)
Primary outcomes
  • Completion of treatment initiation (Baseline to Treatment Session 1 (approximately 2 weeks))
  • Completion of all Treatment sessions (Baseline to Posttreatment (between 2 months and 7 months, depending on treatment selected and speed of progress))
  • Preference for type of treatment (Measured at Pre-Treatment Shared Decision-Making Session)
Sponsor
The University of Texas Health Science Center at San Antonio · other
With: United States Department of Defense
Contacts & investigators
ContactVanessa Jacoby, PhD · contact · jacobyv@uthscsa.edu · 254-289-3468
ContactAlan L Peterson, PhD · contact · petersona3@uthscsa.edu · 210-562-6700
InvestigatorVanessa Jacoby, PhD · principal_investigator, The University of Texas Health Science Center at San Antonio
InvestigatorAlan L Peterson, PhD · principal_investigator, The University of Texas Health Science Center at San Antonio
All locations (2)
Carl R. Darnall Army Medical Center (CRDAMC)Recruiting
Fort Cavazos, Texas, United States
University of Texas Health Science Center at San AntonioRecruiting
San Antonio, Texas, United States
Shared Decision Making in PTSD Treatment · TrialPath