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Набор скоро начнётся NCT06318195

Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care.

Без фазы С лечением Post Traumatic Stress Disorder Acute 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: Condensed Internet delivered prolonged exposure (CIPE).
Кому может быть актуально
Состояния в реестре: Post Traumatic Stress Disorder, Acute 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
Швеция
Следующий шаг
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Официальное название

Internet Delivered Condensed Cognitive Behavioral Treatment (Prolonged Exposure) for Individuals Treated Within Somatic Trauma Care.

Обзор

The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment.

Подробное описание

The study is un-controlled with 250 participants that will undergo a brief trauma-focused Internet-based CBT treatment, delivered as a three-week treatment comprising of four modules (psychoeducation/rational, in vivo exposure, imaginal exposure and relapse prevention). The primary outcome is the PCL-5. Secondary outcomes are level of depression (PHQ-9), quality of life (WSAS) and predictors, moderators and mediators of clinically meaningful change in symptoms, dropout rate, rates of inclusion, attrition, adherence,and negative effects.

Self-reported, qualitative data from participants will be gathered at treatment completion to capture participants' experiences of participating in the intervention, as well as their views on how to further improve the intervention. The treatment effects will be evaluated using a within-group design with repeated measurements. Participants in the study will be will recruited from patients treated in the somatic trauma care at the Karolinska University Hospital in Stockholm, Sweden.

Вмешательства

  • Поведенческое Condensed Internet delivered prolonged exposure (CIPE)
    Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks.

Первичные конечные точки

  • Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) [Срок оценки: week -3, -2 and -1 before treatment start, immediately before start of treatment, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up.]
Вторичные конечные точки (2)
  • Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: week -3 before treatment start, immediately before start of treatment, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up.]
  • Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress. [Срок оценки: week -3 before treatment start, immediately before start of treatment, , weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up.]

Критерии участия

Критерии включения

  • Exposed to trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).
  • PCL-5 total sum score>10
  • ≥ 18 years
  • Situated in Sweden
  • Signed informed consent

Критерии исключения

  • Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
  • Unable to read and write in Swedish
  • Receiving other psychological trauma-focused treatment
  • Ongoing trauma-related threat (e.g., living with a violent spouse)
  • Not stable dose of antidepressant medication the last two weeks

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Швеция · 1 центр
  • Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet — Stockholm

Идентификаторы

NCT: NCT06318195 · 2023-06821-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗