Anxiety & Depression Association of America

Shared Decision Making in PTSD Treatment

Purpose

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).

Condition

Post Traumatic Stress Disorder PTSD

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-stage randomized preference design to examine relationship between patient characteristics, treatment preferences and treatment outcomes.
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

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

Recruiting Locations

More Details

Status: Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio

Study Contact

Vanessa Jacoby, PhD
254-289-3468
jacobyv@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.