Behavioral Health Technician Delivered Written Exposure Therapy

Официальное название

Increasing Access to Evidenced-Based PTSD Treatment in the Military: Behavioral Health Technician Delivered Written Exposure Therapy

Обзор

This study has two main goals. First, it aims to test a treatment called written exposure therapy to see if it can help military service members who have posttraumatic stress disorder (PTSD). Second, it aims to test a new way of making this therapy more accessible in military clinics by utilizing task-sharing with Behavioral Health Technicians (BHTs). PTSD is a common and serious issue among service members. Written exposure therapy (WET) has been proven to be effective for improving PTSD that requires five therapy sessions delivered weekly. This study aims to determine: 1. How well does written exposure therapy help to reduce symptoms of posttraumatic stress for service members with PTSD? 2. Is sharing the therapy tasks with behavioral health technicians is a helpful approach for managing behavioral health clinic patient volume and improving patient outcomes? We plan to recruit a total of 40-59 staff participants, as well as 150 active-duty patient participants with PTSD. We will randomize patient participants to one of two treatment conditions: 1) treatment-as-usual (TAU) or 2) TAU and 5 sessions of WET. Staff and participants will be recruited from two military treatment facilities: 1) Fort Sam Houston in San Antonio (Brooke Army Medical Center) and 2) Camp Pendleton (Naval Hospital at Camp Pendleton). Consented patient participants will: * Complete a PTSD interview via telehealth with a study team member to determine if you are eligible for the study * Be randomly assigned to one of the following conditions: 1) TAU + WET or 2) TAU * Complete up to 8 weeks of behavioral health treatment (either TAU + WET or TAU) * Complete self-report measures before, during, and after treatment, and at a 3- and 6-month follow up assessment after the treatment period * Complete a posttreatment PTSD interview via telehealth with a study team member * A subset of participants will be asked to complete a brief treatment experience interview posttreatment Consented staff participants will: * Participate in an interview about your perceptions of and experiences supporting BHT-delivered WET with a study team member at the VAPAHCS * A subset of participants will also be asked to participate in a brief staff feedback interview approximately 6 months after their first interview

Вмешательства

• Поведенческое Written Exposure Therapy
  Written Exposure Therapy (WET) is a 5-session, trauma-focused intervention in which individuals write about their traumatic experience following scripted instructions.
• Поведенческое Treatment as Usual (TAU)
  Treatment as usual (TAU) will be available to all patient participants. Treatment as usual may include various forms of psychotherapy and or medication management.

Первичные конечные точки

• Clinician Administered PTSD Scale (CAPS-5) [Срок оценки: Change from baseline to immediately post treatment]

Вторичные конечные точки (12)

• Posttraumatic Stress Disorder Checklist (PCL-5) [Срок оценки: Change from baseline through 6 months post treatment]
• Insomnia Severity Index (ISI) [Срок оценки: Change from baseline through 6 months post treatment]
• Generalized Anxiety Disorder 7-Item (GAD-7) Scale [Срок оценки: Change from baseline through 6 months post treatment]
• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Change from baseline through 6 months post treatment]
• Life Events Checklist for DSM-5 (LEC-5) [Срок оценки: Baseline]
• Depressive Symptoms Index-Suicidality Subscale (DSI-SS). [Срок оценки: Change from baseline through 6 months post treatment]
• History of Head Injuries [Срок оценки: Baseline]
• Brief Inventory of Psychosocial Functioning (B-IPF). [Срок оценки: Changes from baseline through 6 months post treatment]
• Credibility/Expectancy Questionnaire (CEQ) [Срок оценки: Immediately after the first treatment session, and immediately after the final treatment session]
• Net Prompter Score [Срок оценки: Post treatment (~6 months post baseline)]
• Patient Satisfaction Survey [Срок оценки: Post treatment (~6 months post baseline)]
• Treatment Engagement [Срок оценки: Through study completion, an average of 2 years]

Критерии участия

Критерии включения

Patient participants:

• Adult active duty personnel ages ≥18
• Clinically significant PTSD symptoms (CAPS-5 ≥ 25).

Clinic staff participants: Individuals working as BHTs, clinic providers, and clinic leaders working at the behavioral health clinics participating in the study

Критерии исключения

Patient participants:

• Current suicide or homicide risk meriting crisis intervention
• Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate attention
• Inability to comprehend the baseline screening questionnaires
• Definite plans to leave the military within 10 weeks

Clinic staff participants:

None

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06789887 · MCA0011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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