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Идёт набор NCT07106593

Treatment for PTSD and Tinnitus

Без фазы С лечением PTSD - Post Traumatic Stress Disorder Posttraumatic Stress Disorder (PTSD) Tinnitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cognitive Processing Therapy, CBT-t.
Кому может быть актуально
Состояния в реестре: PTSD - Post Traumatic Stress Disorder, Posttraumatic Stress Disorder (PTSD), Tinnitus. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Treatment of TBI-Related Tinnitus and Comorbid PTSD: Examination of Neurobiological Markers Related to Symptom Improvement

Обзор

In this study, researchers are examining the best sequence of interventions for posttraumatic stress disorder (PTSD) and tinnitus. Participants will either receive psychotherapy for PTSD first (Cognitive Processing Therapy; CPT), followed by treatment for tinnitus (Cognitive Behavioral Therapy for Tinnitus; CBT-t); or vice-versa. We also aim to identify changes in brain functioning after receiving therapy.

Подробное описание

After consenting to this study, study participants will be asked to speak with a study staff member about stressful or traumatic experiences, complete hearing assessments and questionnaires about exposure to traumatic events, PTSD symptoms, mental and physical health problems, such as depression and substance use, head injuries, and tinnitus. Participants who are able and willing may be asked to provide functional magnetic resonance imaging (MRI) scans before and after treatment. Participants will receive treatment for tinnitus and posttraumatic stress disorder (PTSD) in one of two ways: Cognitive Processing Therapy (CPT) first and then Cognitive Behavioral Therapy for Tinnitus (CBT-t) OR CBT-t first, followed by CPT.

Вмешательства

  • Поведенческое Cognitive Processing Therapy
    CPT (Resick, Monson, \& Chard, 2024) consists of 12 50-minute sessions conducted over a 6- to 12-week period (Resick, Monson, \& Chard, 2008). The three phases of CPT include psychoeducation, processing, and challenging beliefs and assumptions related to the trauma, oneself, and the world.
  • Поведенческое CBT-t
    The standard CBT-t protocol is gathered from the Progressive Tinnitus Management (PTM) program, and includes psychoeducation about how tinnitus can develop. CBT-t includes using behavioral principles to help manage tinnitus reactions, including the use of sounds: soothing sounds, background sound, and interesting sound. CBT-t teaches relaxation exercises, scheduling pleasant activities, and learn how to modify thoughts related to tinnitus. Therapists will also provide basic education on how to p

Первичные конечные точки

  • PTSD Checklist [Срок оценки: Baseline to 6-Month Follow-Up (approximately12 months)]
  • Tinnitus Functional Index [Срок оценки: Baseline to 6-Month Follow-Up (approximately12 months)]

Критерии участия

Критерии включения

  • Adult male and female active duty military personnel and veterans seeking treatment for PTSD
  • Diagnosis of PTSD
  • Person has experienced at least one mild traumatic brain injury (concussion)
  • Ability to speak and read English
  • Stable on any psychotropic medications
  • Meets criteria for chronic subjective and bothersome tinnitus
  • Chronic tinnitus is at least possibly related to head injury

Критерии исключения

  • Currently receiving other talk therapies
  • Severe hearing loss that would prevent the participant from benefiting from therapy
  • Current severe suicidal ideation
  • Psychiatric hospitalization in the last 12 months
  • Moderate to severe substance use that would prevent the participant form benefiting from therapy
  • Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization
  • Significant cognitive impairment
  • Moderate to severe brain damage
  • Neurobiological disorders
  • Temporomandibular joint disorders and/or Meniere's disease that cause acute pain

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The University of Texas Health Science Center at San Antonio — San Antonio

Идентификаторы

NCT: NCT07106593 · STUDY00001126 · HT9425-24-1-0988

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗