Clinical trial NCT06953687: Shared Decision Making in PTSD Treatment
Official title: Implementing and Evaluating a Patient-Centered PTSD Treatment Program for Military Personnel
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder PTSD
Keywords: Shared Decision Making
Patient Characteristics
Patient Treatment preference
Treatment engagement
Treatment outcomes
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2025-05-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-stage randomized preference design to examine relationship between patient characteristics, treatment preferences and treatment outcomes.
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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.

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.

Primary outcomes:
measure: Completion of treatment initiation
timeFrame: Baseline to Treatment Session 1 (approximately 2 weeks)
measure: Completion of all Treatment sessions
timeFrame: Baseline to Posttreatment (between 2 months and 7 months, depending on treatment selected and speed of progress)
measure: Preference for type of treatment
timeFrame: Measured at Pre-Treatment Shared Decision-Making Session
measure: Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Secondary outcomes:
measure: Brief Inventory of Psycho-social Functioning
timeFrame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
measure: Depressive Symptom Index - Suicidality Subscale (DSI-SS)
timeFrame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
measure: Posttraumatic Cognitions Inventory (PTCI)
timeFrame: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)
Other outcomes:
Locations:
city: Fort Cavazos
country: United States
facility: Carl R. Darnall Army Medical Center (CRDAMC)
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Vanessa Jacoby, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Alan L Peterson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.