Shared Decision Making in PTSD Treatment

NCT06953687 | Recruiting DMC

• 3 other identifiers: STUDY00001302HT9425-23-2-0016HT94252320018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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).

Conditions

Post Traumatic Stress Disorder PTSD

Keywords

Shared Decision Making; Patient Characteristics; Patient Treatment preference; Treatment engagement; Treatment outcomes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Brief Inventory of Psycho-social Functioning

  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)

  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)

  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)

  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)

  Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)

Study Arms (6)

Prolonged Exposure (PE) Therapy Massed

EXPERIMENTAL

Daily treatment sessions Monday-Friday for up to 24 sessions

Behavioral: Prolonged Exposure Therapy; Other: Shared Decision Making (SHARE)

Prolonged Exposure (PE) Spaced

EXPERIMENTAL

Weekly treatment formula for up to 24 sessions

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

Behavioral: Cognitive Processing Therapy; Other: Shared Decision Making (SHARE)

Cognitive Processing Therapy (CPT) spaced

EXPERIMENTAL

Weekly treatment formula for up to 24 sessions

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

Behavioral: Written Exposure Therapy; Other: Shared Decision Making (SHARE)

Written Exposure Therapy (WET) Spaced

EXPERIMENTAL

Weekly treatment formula for up to 24 sessions

Behavioral: Written Exposure Therapy; Other: Shared Decision Making (SHARE)

Interventions

Prolonged Exposure Therapy BEHAVIORAL

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

Prolonged Exposure (PE) Spaced; Prolonged Exposure (PE) Therapy Massed

Cognitive Processing Therapy BEHAVIORAL

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

Cognitive Processing Therapy (CPT) Massed; Cognitive Processing Therapy (CPT) spaced

Written Exposure Therapy BEHAVIORAL

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

Written Exposure Therapy (WET) Massed; Written Exposure Therapy (WET) Spaced

Shared Decision Making (SHARE) OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• United States Department of Defense: collaborator

Study Sites (2)

Carl R. Darnall Army Medical Center (CRDAMC)

Fort Cavazos, Texas, 76544, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 33894644 BACKGROUND

• 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.

  PMID: 29362795 BACKGROUND

• 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.

  PMID: 35015065 BACKGROUND

MeSH Terms

Conditions

Combat Disorders

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Jacoby, PhD

CONTACT

254-289-3468; jacobyv@uthscsa.edu

Alan L Peterson, PhD

CONTACT

210-562-6700; petersona3@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two-stage randomized preference design to examine relationship between patient characteristics, treatment preferences and treatment outcomes.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 1, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (2)