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Идёт набор NCT05827406

A Useful Support System for Psychiatric Diagnostics and Follow-up in Adult Psychiatry and Primary Care (ASPP)

Наблюдательное Mental Disorder Symptoms and Signs

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Mental Disorder, Symptoms and Signs. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Ett Användbart Stödsystem för Psykiatrisk Diagnostik Och uppföljning Inom Vuxenpsykiatri Och Primärvård (ASPP)

Обзор

Psychiatric diagnostics involve collecting information about a patient's symptoms, age of onset, development over time, relation to external stress, and ability to function and experience suffering. This information is classified using ICD (World Health Organisation) and DSM (American diagnosis system). Currently, there is a lack of a scientifically evaluated system to support these diagnostics. This project seeks to develop and evaluate a set of self-assessment scales which collect and classify relevant data and serve as support for clinicians. These scales are made up of questions about typical psychiatric symptoms, which are assessed and evaluated using a statistical method (Item Response Theory). After testing and evaluation, a scale could consist of approximately 10 items or less. The scales are then tested together to see if the number of items and scales can be reduced further.

Подробное описание

Psychiatric diagnostics are based on the systematization of information that can be collected about a patient's symptoms and behavior. The information typically concerns the symptoms a patient exhibits, the age of onset for the symptoms, how they have developed over time, whether they are related to any type of external stress, and whether the symptoms cause suffering and/or functional impairment. The collected information can then be classified using diagnostic manuals. The official one is the WHO's International Classification of Diseases (ICD). The American diagnostic system DSM is also used.

Today, there is a lack of a scientifically evaluated (validated) support system for psychiatric diagnostics. With this project, we aim to develop and scientifically evaluate a set of self-assessment scales that can collect and systematize relevant information about patients' symptom profiles, age of onset, long-term course, any possible relation to external stress, and function and suffering, which can serve as support for clinicians in the diagnostic process. Some of the scales are also intended to be used for follow-up.

Assessment scales consist of sets of questions or statements, which in this context are called "items." They describe deviant psychological symptoms (psychopathology) as gradually increasing phenomena (dimensions). In the project, we develop sets of items based on the most common diagnostic areas within psychiatry and general medicine. These are then tested on patients and evaluated using a modern statistical method specialized for developing scales, called Item Response Theory (IRT). The first sets of items contain between approximately 30 and 60 items. After evaluation, only the best-performing items are retained. Testing is repeated on new patient groups until they function optimally. The goal is for each scale to consist of approximately 10 items. Thereafter, the reduced scales are tested together and evaluated with IRT to, if possible, reduce the number of scales and items.

Первичные конечные точки

  • Scalability H [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • Patients with psychiatric problems

Критерии исключения

  • None

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Швеция · 5 центров
  • Wemind — Stockholm
  • Prima vuxen — Stockholm
  • Gustavsbergs vårdcentral — Stockholm
  • Stuvsta vårdcentral — Stockholm
  • Psykiatri Sydväst — Stockholm

Публикации

  • Adler M, Liberg B, Andersson S, Isacsson G, Hetta J. Development and validation of the Affective Self Rating Scale for manic, depressive, and mixed affective states. Nord J Psychiatry. 2008;62(2):130-5. doi: 10.1080/08039480801960354. PMID 18569776
  • Adler M, Brodin U. An IRT validation of the Affective Self Rating Scale. Nord J Psychiatry. 2011 Dec;65(6):396-402. doi: 10.3109/08039488.2011.577187. Epub 2011 May 4. PMID 21539501
  • Adler M, Backlund L, Edman G, Osby U. Symptoms and treatment of bipolar patients in Sweden. Int J Psychiatry Clin Pract. 2012 Sep;16(3):170-7. doi: 10.3109/13651501.2011.653377. Epub 2012 Mar 21. PMID 22432978
  • Adler M, Hetta J, Isacsson G, Brodin U. An item response theory evaluation of three depression assessment instruments in a clinical sample. BMC Med Res Methodol. 2012 Jun 21;12:84. doi: 10.1186/1471-2288-12-84. PMID 22721257
  • Isacsson G, Adler M. Randomized clinical trials underestimate the efficacy of antidepressants in less severe depression. Acta Psychiatr Scand. 2012 Jun;125(6):453-9. doi: 10.1111/j.1600-0447.2011.01815.x. Epub 2011 Dec 19. PMID 22176585
  • Cameron IM, Scott NW, Adler M, Reid IC. A comparison of three methods of assessing differential item functioning (DIF) in the Hospital Anxiety Depression Scale: ordinal logistic regression, Rasch analysis and the Mantel chi-square procedure. Qual Life Res. 2014 Dec;23(10):2883-8. doi: 10.1007/s11136-014-0719-3. Epub 2014 May 22. PMID 24848597
  • Abe C, Liberg B, Song J, Bergen SE, Petrovic P, Ekman CJ, Sellgren CM, Ingvar M, Landen M. Longitudinal Cortical Thickness Changes in Bipolar Disorder and the Relationship to Genetic Risk, Mania, and Lithium Use. Biol Psychiatry. 2020 Feb 1;87(3):271-281. doi: 10.1016/j.biopsych.2019.08.015. Epub 2019 Aug 29. PMID 31635761
  • Liberg B, Rahm C, Panayiotou A, Pantelis C. Brain change trajectories that differentiate the major psychoses. Eur J Clin Invest. 2016 Jul;46(7):658-74. doi: 10.1111/eci.12641. Epub 2016 Jun 15. PMID 27208657

Идентификаторы

NCT: NCT05827406 · 2022-07160-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗