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Shared Decision Making in PTSD Treatment

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Not yet enrolling

Conditions

Post Traumatic Stress Disorder PTSD

Treatments

Behavioral: Cognitive Processing Therapy
Other: Shared Decision Making (SHARE)
Behavioral: Prolonged Exposure Therapy
Behavioral: Written Exposure Therapy

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT06953687
STUDY00001302
HT94252320018 (Other Grant/Funding Number)
HT9425-23-2-0016 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 6 patient groups

Prolonged Exposure (PE) Therapy Massed
Experimental group
Description:
Daily treatment sessions Monday-Friday for up to 24 sessions
Treatment:
Behavioral: Prolonged Exposure Therapy
Other: Shared Decision Making (SHARE)
Prolonged Exposure (PE) Spaced
Experimental group
Description:
Weekly treatment formula for up to 24 sessions
Treatment:
Behavioral: Prolonged Exposure Therapy
Other: Shared Decision Making (SHARE)
Cognitive Processing Therapy (CPT) Massed
Experimental group
Description:
Daily treatment sessions Monday-Friday for up to 24 sessions
Treatment:
Other: Shared Decision Making (SHARE)
Behavioral: Cognitive Processing Therapy
Cognitive Processing Therapy (CPT) spaced
Experimental group
Description:
Weekly treatment formula for up to 24 sessions
Treatment:
Other: Shared Decision Making (SHARE)
Behavioral: Cognitive Processing Therapy
Written Exposure Therapy (WET) Massed
Experimental group
Description:
Daily treatment sessions Monday-Friday for up to 24 sessions
Treatment:
Behavioral: Written Exposure Therapy
Other: Shared Decision Making (SHARE)
Written Exposure Therapy (WET) Spaced
Experimental group
Description:
Weekly treatment formula for up to 24 sessions
Treatment:
Behavioral: Written Exposure Therapy
Other: Shared Decision Making (SHARE)

Trial contacts and locations

2

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Central trial contact

Vanessa Jacoby, PhD; Alan L Peterson, PhD

Data sourced from clinicaltrials.gov

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