Shared Decision Making in PTSD Treatment

Официальное название

Implementing and Evaluating a Patient-Centered PTSD Treatment Program for Military Personnel

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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 reminder
• Поведенческое 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. T
• Другое 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 treat

Первичные конечные точки

• Completion of treatment initiation [Срок оценки: Baseline to Treatment Session 1 (approximately 2 weeks)]
• Completion of all Treatment sessions [Срок оценки: Baseline to Posttreatment (between 2 months and 7 months, depending on treatment selected and speed of progress)]
• Preference for type of treatment [Срок оценки: Measured at Pre-Treatment Shared Decision-Making Session]
• Posttraumatic Stress Disorder Checklist (PCL-5) [Срок оценки: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)]

Вторичные конечные точки (5)

• Brief Inventory of Psycho-social Functioning [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline to 1 month follow up assessment (between 2 months and 7 months, depending on treatment selected and speed of progress)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Carl R. Darnall Army Medical Center (CRDAMC) — Fort Cavazos
• University of Texas Health Science Center at San Antonio — San Antonio

Публикации

• 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
• 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. 2 PMID 29362795
• 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/jamanetwor PMID 35015065

Идентификаторы

NCT: NCT06953687 · STUDY00001302 · HT9425-23-2-0016 · HT94252320018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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