M3VAS Validation in Polish Population

Recruiting

• Conditions: Depressive Disorder
• Interventions: Diagnostic Test: The Maudsley 3-item Visual Analogue Scale (M3VAS)

• Registration Number: NCT06412562
• Lead Sponsor: Medical University of Gdansk

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-09
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Study First Posted: 2024-05-14
• Last Update Posted: 2024-05-14
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major Depressive Episode	The Maudsley 3-item Visual Analogue Scale (M3VAS)	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.

Primary Outcome Measures

Name	Time	Method
The Maudsley 3-item Visual Analogue Scale (M3VAS)	Baseline	To analyze internal consistency and factor analysis

Secondary Outcome Measures

Name	Time	Method
16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16)	Baseline	To analyze convergent validity with The Maudsley 3-item Visual Analogue Scale (M3VAS)

Trial Locations

Locations (1)

Medical University of Gdańsk; 🇵🇱 Gdańsk, Poland