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

Mental Disorder Clinical Trial

— ASPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827406
• Other study ID #: 2022-07160-01
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: Mats O Adler, MD
• Phone: +46707717977
• Email: mats.adler[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with psychiatric problems

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Symptoms and Signs

Locations

Country	Name	City	State
Sweden	Gustavsbergs vårdcentral	Stockholm
Sweden	Prima vuxen	Stockholm
Sweden	Psykiatri Sydväst	Stockholm
Sweden	Stuvsta vårdcentral	Stockholm
Sweden	Wemind	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Liberg B, Klauser P, Harding IH, Adler M, Rahm C, Lundberg J, Masterman T, Wachtler C, Jonsson T, Kristoffersen-Wiberg M, Pantelis C, Wahlund B. Functional and structural alterations in the cingulate motor area relate to decreased fronto-striatal coupling — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scalability H	Scalability coefficient H (ranging from 0 to 1) of each subdimension as assessed with Mokken Item Response Theory. A minimal requirement of H = 0.4 is deemed necessary for inclusion in the DPS.	Day 1