M3VAS Validation in Polish Population

NCT06412562 | Recruiting

• 1 other identifier: M3VAS_PL
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

anhedonia; low mood; suicidality; depression; m3vas

Outcome Measures

Primary Outcomes (1)

• The Maudsley 3-item Visual Analogue Scale (M3VAS)

  To analyze internal consistency and factor analysis

  Baseline

Secondary Outcomes (1)

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

  Baseline

Study Arms (1)

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.

Diagnostic Test: The Maudsley 3-item Visual Analogue Scale (M3VAS)

Interventions

The Maudsley 3-item Visual Analogue Scale (M3VAS) 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).

Also known as: 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16)

Major Depressive Episode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients referred to the tertiary-reference unit for mood disorders with MDD or BD diagnosis, currently either with current depression or euthymic

You may qualify if:

• Diagnosis as provided by DSM-5 criteria:
• Major depressive disorder (MDD) Bipolar disorder (BD)

You may not qualify if:

• Diagnosis as provided by DSM-5 criteria:
• Psychotic disorders Current Mania or hypomania within bipolar disorder (BD)

Sponsors & Collaborators

• Medical University of Gdansk: lead
• King's College London: collaborator

Study Sites (1)

Medical University of Gdańsk

Gdansk, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 33418379 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder; Anhedonia; Consciousness Disorders; Suicidal Ideation; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: May 9, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

PL (1)