A Useful Support System for Psychiatric Diagnostics and Follow-up in Adult Psychiatry and Primary Care (ASPP)
NCT ID: NCT05827406
Last Updated: 2023-10-18
Study Results
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Basic Information
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RECRUITING
2200 participants
OBSERVATIONAL
2023-05-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Group 1: item set 1
A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 1) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We assume 50 % participation to receive 100 responses.
No interventions assigned to this group
Group 2: reduced item set 1
We analyze data from group 1 and optimize item set 1 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 1 fails to validate, we may need to change it and recruit additional groups to optimize it.
No interventions assigned to this group
Group 3: item set 2
A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 2) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment.
No interventions assigned to this group
Group 4: reduced item set 2
We analyze data from group 3 and optimize item set 2 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 2 fails to validate, we may need to change it and recruit additional groups to optimize it
No interventions assigned to this group
Group 5: item set 3
A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 3) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment.
No interventions assigned to this group
Group 6: reduced item set 3
We analyze data from group 5 and optimize item set 3 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 3 fails to validate, we may need to change it and recruit additional groups to optimize it
No interventions assigned to this group
Group 7: item set 4
A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 4) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment.
No interventions assigned to this group
Group 8: reduced item set 4
We analyze data from group 7 and optimize item set 4 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 4 fails to validate, we may need to change it and recruit additional groups to optimize it.
No interventions assigned to this group
Group 9: item set 5
A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 5) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment.
No interventions assigned to this group
Group 10: reduced item set 5
We analyze data from group 9 and optimize item set 5 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 5 fails to validate, we may need to change it and recruit additional groups to optimize it.
No interventions assigned to this group
Group 11: item set 6
A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 6) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment.
No interventions assigned to this group
Group 12: reduced item set 6
We analyze data from group 11 and optimize item set 6 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 6 fails to validate, we may need to change it and recruit additional groups to optimize it.
No interventions assigned to this group
Group 13: combined item sets
In this group, we aim to combine the optimized item sets in item sets 1-6. We recruit 1000 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the combined item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment.
No interventions assigned to this group
Group 14: reduced combined item sets
We analyze data from group 13 and optimize the combined item set for the best measurement with the least number of items and the least number of dimensions. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced combined item set fails to validate, we may need to change it and recruit additional groups to optimize it.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Mats Adler
Principal Investigator
Principal Investigators
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Mats O Adler, MD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet, Department of Clinical Neuroscience
Locations
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Wemind
Stockholm, , Sweden
Prima vuxen
Stockholm, , Sweden
Gustavsbergs vårdcentral
Stockholm, , Sweden
Stuvsta vårdcentral
Stockholm, , Sweden
Psykiatri Sydväst
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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 in major depressive disorder with psychomotor disturbances. Front Psychiatry. 2014 Dec 4;5:176. doi: 10.3389/fpsyt.2014.00176. eCollection 2014.
Other Identifiers
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2022-07160-01
Identifier Type: -
Identifier Source: org_study_id
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