Shared Decision Making in PTSD Treatment

Part of paid clinical trials in Fort Cavazos, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06953687
Status
Recruiting
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Conditions

  • Post Traumatic Stress Disorder PTSD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.
  • 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.

Study Details

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).

Key Dates

Start date
May 9, 2025
Status verified
Jun 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Prolonged Exposure (PE) Therapy Massed
    Daily treatment sessions Monday-Friday for up to 24 sessions
  • Experimental: Prolonged Exposure (PE) Spaced
    Weekly treatment formula for up to 24 sessions
  • Experimental: Cognitive Processing Therapy (CPT) Massed
    Daily treatment sessions Monday-Friday for up to 24 sessions
  • Experimental: Cognitive Processing Therapy (CPT) spaced
    Weekly treatment formula for up to 24 sessions
  • Experimental: Written Exposure Therapy (WET) Massed
    Daily treatment sessions Monday-Friday for up to 24 sessions
  • Experimental: Written Exposure Therapy (WET) Spaced
    Weekly treatment formula for up to 24 sessions

Primary Outcome Measure

Completion of treatment initiation [ Time Frame: Baseline to Treatment Session 1 (approximately 2 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Carl R. Darnall Army Medical Center (CRDAMC)Fort CavazosTexas76544
Rodney Merkley, PsyD
254-553-6854
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Vanessa Jacoby, PhD
[email protected]
254-289-3468

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By research site
Carl R. Darnall Army Medical Center (CRDAMC)· Fort Cavazos, TXUniversity of Texas Health Science Center at San Antonio· San Antonio, TX

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