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Идёт набор NCT06288711

Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD

Без фазы С лечением Opioid Use Disorder Posttraumatic Stress Disorder

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: Prolonged exposure therapy, Financial incentives, Treatment as usual.
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder, Posttraumatic Stress Disorder. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD.

Подробное описание

Nearly 90% of individuals with opioid use disorder (OUD) report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD). Patients with co-occurring PTSD and OUD are at significantly greater risk for poor substance use and mental health outcomes vs. those with OUD alone. Although Prolonged Exposure (PE) therapy is a first-line treatment for PTSD, its efficacy is commonly undermined by poor attendance.

The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD. In this randomized trial, adults with PTSD (N = 135) who are currently maintained on MOUD will be randomly assigned to one of three conditions: (a) Treatment as usual (TAU), (b) Prolonged exposure therapy (PE), or (c) Prolonged exposure therapy + attendance-contingent financial incentives (PE+). Participants randomized to the TAU condition will continue to receive standard MOUD treatment from their current treatment provider and complete remotely-administered assessments of PTSD symptoms, psychosocial functioning and drug use with an evaluator trained in the administration of all study measures and blinded to treatment condition at intake, monthly during the 12-week intervention, and at 3- and 6-months post-study, but will not receive PTSD treatment. In addition to receiving continued MOUD treatment from their current provider and completing assessments as above, participants assigned to PE will also receive telemedicine-delivered PE consisting of 12 weekly, individual sessions with trained master's- or doctoral-level therapists. PE sessions consist of imaginal exposure (i.e., revisiting and recounting traumatic memories) and processing the memory (i.e., discussing thoughts and feelings related to revisiting the memory). Participants also complete homework assignments consisting of repeated listening to a recording of the imaginal exposure and repeated in vivo exposure to safe situations that have previously avoided because of trauma-related distress. Participants assigned to the PE+ condition will receive the procedures noted above for the PE condition plus attendance-contingent financial incentives delivered immediately following completion of telemedicine-delivered PE sessions via a digital payment delivery platform.

Вмешательства

  • Поведенческое Prolonged exposure therapy
    Twelve weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by therapists trained in prolonged exposure therapy.
  • Поведенческое Financial incentives
    Financial incentives contingent upon completion of prolonged exposure therapy sessions
  • Поведенческое Treatment as usual
    Continued standard buprenorphine or methadone maintenance treatment from current treatment provider.

Первичные конечные точки

  • Prolonged exposure therapy session attendance [Срок оценки: From baseline to week 12]
  • Prolonged exposure therapy completion [Срок оценки: From baseline to week 12]
  • Change in posttraumatic stress disorder symptom severity - clinician rated [Срок оценки: From baseline to week 12]
Вторичные конечные точки (8)
  • Change in non-prescribed drug use - objective [Срок оценки: From baseline to week 12 and 3, 6 months post-study]
  • Change in non-prescribed drug use - self-reported [Срок оценки: From baseline to week 12 and 3, 6 months post-study]
  • Change in opioid craving [Срок оценки: From baseline to week 12]
  • Medications for opioid use disorder treatment retention [Срок оценки: From baseline to week 12 and 3, 6 months post-study]
  • Prolonged exposure therapy acceptability [Срок оценки: From baseline to week 12]
  • Satisfaction with prolonged exposure therapy delivered via telemedicine [Срок оценки: From baseline to week 12]
  • Prolonged exposure therapy homework adherence [Срок оценки: From baseline to week 12]
  • Change in posttraumatic stress disorder symptom severity - self-reported [Срок оценки: From baseline to week 12]

Критерии участия

Критерии включения

  • >18 years old
  • Maintained on a stable methadone or buprenorphine dose for >1 month prior to the study
  • Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
  • Participants receiving psychotropic medications must be maintained on a stable dose for >1 month prior to enrollment.

Критерии исключения

  • Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
  • Cognitive impairment as evidenced by scores <22 on the Videoconference-based Mini Mental Status Examination (MMSE; Folstein, et al., 1975)
  • Enrolled in another ongoing evidence-based treatment for PTSD.
  • Pregnancy as verified by pregnancy test
  • No access to cellular service

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Vemont — Burlington

Идентификаторы

NCT: NCT06288711 · CHRBSS #STUDY00002538 · R01DA057308

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗