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Набор по приглашению NCT07313280

Central Sensitization Syndromes and Post-Traumatic Stress in Women: Psychological Profile and Intervention

Без фазы С лечением Posttraumatic Stress Symptom Central Sensitization Chronic Pain Syndrome

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: CSS-PTSD psychological interventions.
Кому может быть актуально
Состояния в реестре: Posttraumatic Stress Symptom, Central Sensitization, Chronic Pain Syndrome. Базовые параметры: 18 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Psychological Profile Associated With the Complexity of Central Sensitization Syndromes, Comorbid With Trauma and Post-Traumatic Stress Disorder in Women: Testing the Effectiveness of a Person-Centered Psychological Intervention

Обзор

Central Sensitivity Syndromes (CSSs) are a group of conditions that are highly prevalent, particularly among women, and often occur alongside post-traumatic stress disorder (PTSD). This research project has two aims: Study 1) to investigate the psychological profiles of women with CSS-PTSD comorbidity; and Study 2) to design and evaluate the effectiveness of distinct interventions for each profile identified in Study 1.

Подробное описание

Central Sensitivity Syndromes (CSSs) are a group of conditions, including fibromyalgia and chronic pelvic pain, associated with symptoms such as perceived pain intensity, depression, anxiety, stress, sleep disturbances, and disability. These syndromes are highly prevalent, particularly among women, and often occur alongside post-traumatic stress disorder (PTSD). This condition stems from a variety of traumatic experiences and manifests as a range of symptoms in individuals with different psychological profiles. However, not all individuals who experience trauma develop PTSD or CSSs, nor do all individuals with CSSs have PTSD or exhibit the same symptom patterns. Transdiagnostic psychological variables may contribute to the development and maintenance of both conditions. Commonly observed factors in both CSSs and PTSD include emotional dysregulation, anxiety sensitivity, experiential avoidance, distress intolerance, and dissociation. These transdiagnostic vulnerability variables could be associated with each profile. Identifying these profiles may enable targeted interventions that address the underlying vulnerabilities driving CSS-PTSD comorbidity. By aligning treatment to individual vulnerability patterns, this approach aims to improve outcomes for women affected by CSS-PTSD.

Four PTSD profiles will be identified:

* Reactive (with prominent intrusions, avoidance, and hyperarousal). * Dysphoric (with anhedonia and negative affect). * Dissociative (with high negative and positive dissociative symptoms). * Mixed (with high levels of all PTSD symptoms). However, no studies have analysed how these transdiagnostic vulnerability variables (emotion dysregulation, anxiety sensitivity, experiential avoidance, distress intolerance, and dissociation) are grouped and shape the different PTSD symptom profiles in populations with either PTSD or comorbid CSS. Therefore, the analysis of the association between PTSD profiles and transdiagnostic variables is exploratory.

The treatments will be developed based on the variables associated with each profile identified in Study 1.

Вмешательства

  • Поведенческое CSS-PTSD psychological interventions
    The interventions will be developed based on the techniques previously developed within cognitive behavioural approaches, which have demonstrated efficacy in treating both conditions.

Первичные конечные точки

  • Change in anxiety sensitivity [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
  • Change in emotion dysregulation [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
  • Change in experiential avoidance [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
  • Change in distress intolerance [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
  • Change in dissociative symptoms [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
  • Change in daily symptom monitoring [Срок оценки: Treatment (periprocedural), 1-months follow-up.]
Вторичные конечные точки (6)
  • Change in Central Sensitization Indexes [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
  • Change in posttraumatic stress symptoms [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
  • Change in stress symptoms [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
  • Change in anxiety and depressive symptoms [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
  • Change in sleep disturbance [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
  • Change in pain interference [Срок оценки: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]

Критерии участия

Критерии включения

  • being a biological woman.
  • having a medical diagnosis of CSS.
  • scoring >36 on the Posttraumatic Stress Disorder Checklist for DSM-5, which indicates PTSD in people with chronic pain.
  • having the ability to understand and sign the informed consent form.

Критерии исключения

  • having a diagnosis of serious mental illness or neurodegenerative disease.
  • not being fluent in spoken and written Spanish.
  • undergoing treatment for an oncological, degenerative, or terminal disease.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Испания · 3 центра
  • Hospital Universitario Regional de Málaga_Hospital Civil — Málaga
  • Hospital Universitario Virgen de la Victoria — Málaga
  • Área de Gestión Sanitaria Este de Málaga-Axarquía — Málaga

Идентификаторы

NCT: NCT07313280 · PID2023-152784OA-I00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗