Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress

Официальное название

Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial

Обзор

Populations facing health disparities include groups with significantly higher rates of posttraumatic stress disorder than the general population who frequently experience lived experience stress, which may complicate posttraumatic stress disorder symptom presentations. However, there are currently no posttraumatic stress disorder treatments designed to meet the unique needs of these individuals. The proposed study will pilot an adaptation of Cognitive Processing Therapy (a gold-standard treatment for posttraumatic stress disorder) that has been modified to incorporate the impact of lived experience stress as an additional treatment target. This project has the potential to advance our understanding of how to enhance Cognitive Processing Therapy in order to optimize posttraumatic stress disorder treatment response and mitigate health disparities.

Подробное описание

This study will occur in two phases.

Phase 1 will involve refining Cognitive Processing Therapy Lived Experience Adapted Protocol (CPT-LEAP) and includes beta testing of CPT-LEAP (n=6).

Phase 2 will involve a pilot RCT in which participants (n=52) will be randomized (1:1) to standard CPT or CPT-LEAP. The investigators anticipate 26 participants will be enrolled in each treatment arm.

Вмешательства

• Поведенческое Standard CPT
  CPT focuses on teaching skills to identify and challenge PTSD-maintaining maladaptive beliefs related to the trauma itself, the world, and oneself. Worksheets and assignments are given between each session.
• Поведенческое CPT-LEAP
  CPT-LEAP frames each session in relation to beliefs about both traumatic and lived experience stressors and their interactions and impacts, including not only beliefs about oneself, others, and the world, but also one's identity, and use of relevant examples throughout the protocol.

Первичные конечные точки

• Post traumatic stress disorder symptoms (PTSD) [Срок оценки: immediately after treatment, 3 months]

Критерии участия

Критерии включения

• Current diagnosis of PTSD
• Self-identification as a sexual or gender minority (SGM) individual
• Endorsement of SGM stress experiences with moderate distress
• For patients who take psychiatric medication, stable dose one month prior to enrollment
• Reside in Massachusetts.

Критерии исключения

• Current active suicidal or homicidal ideation with intent or plan
• Unstable bipolar disorder/current mania
• Unstable psychotic disorder/current psychosis
• Current severe substance use that warrants immediate medical attention
• Cognitive impairment or organic disorder (e.g., advanced dementia, severe traumatic brain injury) that impairs ability to complete CPT procedures
• Past completion of CPT or current trauma-focused treatment
• Unwillingness to consent to audio or video recording of assessment and treatment sessions

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

Лечение

Центры проведения

США · 1 центр

• VA Boston Healthcare System — Jamaica Plain

Идентификаторы

NCT: NCT07714083 · H-45022 · 1K23MH133986-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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