M3VAS Validation in Polish Population

NCT ID: NCT06412562

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-09
• Study Completion Date: 2026-09-30

Brief Summary

Low mood and anhedonia represent the fundamental symptoms of major depressive disorder (MDD). Nevertheless, there is currently no standardized visual analogue scale available to assess the extent of both symptoms concurrently. The Maudsley 3-item Visual Analogue Scale (M3VAS) is a newly developed tool for participants to self-assess core symptoms of depression: mood quality, pleasure experience (anhedonia), and suicidality. Despite suicidality not being a primary symptom, it is included due to its critical relevance to safety. Participants will be instructed to rate the intensity and frequency of their experiences over the preceding two weeks by marking a 100 mm ungraded line. A researcher will then assign a numerical value based on the mark's position, utilizing the left edge as 0 and the right as 100. The total score range, combining the three symptoms, ranged from 0 (minimum) to 300 (maximum). The M3VAS exhibited good psychometric properties in British population. In this study, the objective is to assess the psychometric properties of the scale within the Polish population diagnosed with major depressive episode within major depressive disorder or bipolar disorder.

Conditions

Depressive Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Major Depressive Episode

Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Major Depressive Disorder (MDD) or Bipolar Disorder (BD), as determined by a psychiatrist.

The Maudsley 3-item Visual Analogue Scale (M3VAS)

Intervention Type: DIAGNOSTIC_TEST

Patients will be asked to complete The Maudsley 3-item Visual Analogue Scale (M3VAS) and 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16).

Interventions

The Maudsley 3-item Visual Analogue Scale (M3VAS)

Patients will be asked to complete The Maudsley 3-item Visual Analogue Scale (M3VAS) and 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16)

Eligibility Criteria

Inclusion Criteria

Diagnosis as provided by DSM-5 criteria:

Major depressive disorder (MDD) Bipolar disorder (BD)

Exclusion Criteria

Diagnosis as provided by DSM-5 criteria:

Psychotic disorders Current Mania or hypomania within bipolar disorder (BD)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Gdańsk

Gdansk, , Poland

Site Status: RECRUITING

Countries

Poland

Facility Contacts

Alina Wilkowska, MD, PhD

Role: primary

alina.wilkowska@gumed.edu.pl

+48 58 584 46 50

Aleksander Kwaśny, MD

Role: backup

+48 58 584 46 50

References

Moulton CD, Strawbridge R, Tsapekos D, Oprea E, Carter B, Hayes C, Cleare AJ, Marwood L, Mantingh T, Young AH. The Maudsley 3-item Visual Analogue Scale (M3VAS): Validation of a scale measuring core symptoms of depression. J Affect Disord. 2021 Mar 1;282:280-283. doi: 10.1016/j.jad.2020.12.185. Epub 2020 Dec 31.

Reference Type: BACKGROUND

PMID: 33418379 (View on PubMed)

Other Identifiers

M3VAS_PL

Identifier Type: -

Identifier Source: org_study_id