PACE Versus PE for CPTSD (PACE Trial)
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: PACE, PE.
- Кому может быть актуально
- Состояния в реестре: Complex 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
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Patient-centred Modular Cognitive Behavioural Therapy Versus Prolonged Exposure Therapy for Complex Post-traumatic Stress Disorder: a Randomised Trial
Обзор
The objective of this pragmatic trial is to evaluate the beneficial and harmful effects of Patient-centred Modular Cognitive Behavioural Therapy (PACE) compared with the standard post-traumatic stress disorder (PTSD) treatment, Prolonged Exposure (PE), for adults with an ICD-11 diagnosis of Complex post-traumatic stress disorder (CPTSD).
Подробное описание
This trial is designed as an investigator-initiated, multi-centre, parallel group, randomised clinical superiority trial of PACE versus standard PTSD treatment, PE, for ICD-11 CPTSD. The total sample size will be 228 participants. The trial will take place at the Danish Veteran Centre and two clinics in the Mental Health Services in Denmark. The participants will be adult military veterans and psychiatric outpatients with ICD-11 CPTSD. After giving their consent, participants will be randomly assigned (1:1) to receive either PACE or PE.
The experimental intervention will be 26 hours PACE (delivered as 26 1-hour sessions of weekly individual psychotherapy). The control intervention will be 25.5 hours PE therapy (17 sessions of weekly individual psychotherapy delivered for 90-minutes).
Outcome assessors, data managers, statisticians, and conclusion drawers will be blinded to group allocation. The primary outcome will be clinician-rated ICD-11 CPTSD symptom severity assessed with the International Trauma Interview (ITI) at 9 months after randomisation. Secondary outcomes include serious adverse events, suicide attempts, symptoms of depression, stress, and anxiety, alcohol use problems, mental well-being, and functional impairment assessed at 9 months after randomisation.
Вмешательства
- Другое PACE
26 hours PACE (delivered as 26 1-hour sessions of weekly individual psychotherapy). - Другое PE
25.5 hours PE therapy (17 sessions of weekly individual psychotherapy delivered for 90-minutes).
Первичные конечные точки
- ITI [Срок оценки: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)]
Вторичные конечные точки (7)
- SAE [Срок оценки: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)]
- Suicides and suicide attempts [Срок оценки: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)]
- DASS-21, depression [Срок оценки: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)]
- DASS-21, anxiety [Срок оценки: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)]
- AUDIT [Срок оценки: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)]
- WHO-5 [Срок оценки: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)]
- SDS [Срок оценки: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)]
Критерии участия
Критерии включения
- Age: ≥18 years.
- Referred to PTSD treatment (which requires absence of severe psychiatric comorbidity dominating the clinical presentation, hindering trauma-focused psychotherapy, assessed by the referring clinician at point of referral (e.g. major depressive disorder, ADHD, autism spectrum disorders, personality disorders, psychotic disorders, alcohol- or substance use, and aggressive behaviours)).
- Diagnosis of CPTSD according to ICD-11, assessed by the interviewing investigator using the ITI interview.
- Written informed consent.
Критерии исключения
- Current self-harm or severe suicidality defined as at least one self-harm episode or one suicide-attempt the last three months, as assessed by the interviewing investigator.
- Any other condition that markedly compromises the participant's ability to adhere to the treatment programme or follow-up, such IQ < 70 based on clinical judgement.
- Currently involved in legal proceedings concerning work accident compensation related to PTSD, or trial regarding child custody.
- Does not understand Danish or needs an interpreter.
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
Дания · 10 центров
- The Outpatient Clinic for PTSD, Department of Affective Disorders, Aarhus University Hospi — Aarhus
- The Outpatient Clinic for PTSD at Ballerup, Mental Health Centre Ballerup, Capital Region — Ballerup Municipality
- Danish Veterans Centre - Høvelte: Livgardens Kaserne, Høveltevej 117 — Birkerød
- Danish Veterans Centre - Svanemøllen: Svanemøllens Kaserne, Ryvangs Allé 1-3 — Copenhagen
- Danish Veterans Centre - Fredericia: Ryes Kaserne, Treldevej 110 — Fredericia
- Danish Veterans Centre - Holstebro: Jydske Dragonregiment, Dragonkasernen 1 — Holstebro
- Danish Veterans Centre - Karup: Flyvestation Karup, Herningvej 30 — Karup
- Danish Veterans Centre - Aalborg: Aalborg Kaserner, Gl. Høvej 34 — Nørresundby
- … и ещё 2 центра
Идентификаторы
NCT: NCT07371156 · PACE trial · H-25066014