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

Recruiting

• Conditions: Mental Disorder; Symptoms and Signs

• Registration Number: NCT05827406
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-04-21
• Study First Posted: 2023-04-25
• Study Start: 2023-05-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

• Patients with psychiatric problems

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scalability H	Day 1	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.

Trial Locations

Locations (5)

Stuvsta vårdcentral; 🇸🇪 Stockholm, Sweden

Psykiatri Sydväst; 🇸🇪 Stockholm, Sweden

Prima vuxen; 🇸🇪 Stockholm, Sweden

Wemind; 🇸🇪 Stockholm, Sweden

Gustavsbergs vårdcentral; 🇸🇪 Stockholm, Sweden