Musical Attention Control and Executive Function Training for Adults with MDD

February 27, 2025 updated by: Unity Health Toronto
The investigators have developed music-based cognitive training sessions derived from Neurologic Music Therapy (NMT) techniques. The music-based cognitive training sessions will address areas of attention and executive function, which appear to progress over time and worsen as an individual experiences more episodes of depression. The aim of this pilot is to test 8-weeks of music-based cognitive training to improve cognitive function among adults with major depressive disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Major Depressive Disorder (MDD) is a lifelong condition and is the leading cause of disability in the world. MDD is a multifaceted mood disorder and due to its complex nature, this mental health diagnosis affects emotional, behavioural, and cognitive processing. Cognitive dysfunction appears to progress over time and worsens as the individual experiences more episodes of depression. Because of this, it is critical to continue to investigate and formulate effective treatment that can target and improve not only depressive symptoms, but also address overall cognitive function. Thus, the investigators propose implementing music-based cognitive training derived from Neurologic Music Therapy (NMT) techniques to address cognitive dysfunction experienced by adults diagnosed with MDD. Music-based interventions, specifically from the NMT approach have been shown to physically change the human brain when working on cognition in areas of attention and executive function, however little is known of these applications with adults with MDD. The aim of this pilot is to test 8-weeks of music-based cognitive training to improve cognitive function among adults with MDD.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1M8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of MDD meeting the Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-V) criteria
  • Experiencing suicidal ideation in the past week (Beck Scale for Suicide Ideation >10)
  • Have received more than 12 sessions of psychotherapy
  • Stable medication use > 4 weeks
  • Ability to undergo music-based cognitive training sessions in English
  • Capable of giving informed consent

Exclusion Criteria:

  • The presence of cognitive impairment that would limit consent or understanding of neurologic music therapy
  • The presence of active psychosis
  • The presence of mood and suicidal symptom severity requiring immediate treatment
  • Hearing impairment
  • Participation in music therapy 6 months prior to study
  • Private music lessons for a period of 1 year prior to study
  • Unwilling or unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music-based cognitive training
Music-based cognitive training sessions are derived from two Neurologic Music Therapy techniques: Musical Attention Control Training (MACT) and Musical Executive Function Training (MEFT). MACT exercises will focus on sustained and selective attention to emphasise flexibility and adaptability of the auditory attention system. MEFT exercises will provide opportunity for decision making, problem solving, reasoning, comprehending, organising, initiating, inhibiting, evaluating, analysing, and creating.
Other: Music-based cognitive training
8-week music-based cognitive training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inhibition using the Go/No Go Task
Time Frame: From baseline to 8-weeks
This cognitive task measures response time, accuracy, commission errors, omission errors, and reaction time variability.
From baseline to 8-weeks
Change in working memory capacity using the Digit Span Forward and Backward Test
Time Frame: From baseline to 8-weeks
This cognitive task measures span length, correct recall, error rate, and reaction time.
From baseline to 8-weeks
Change in cognitive flexibility and executive control using the Shifting Attention test
Time Frame: From baseline to 8-weeks
This cognitive task measures the ability to shift attention between different stimuli, assessing the speed and accuracy with which the individual can shift their attention and switch between different rules.
From baseline to 8-weeks
Change in visual attention and task switching using the Trail Making A and B test
Time Frame: From baseline to 8-weeks

This cognitive task measures the time to complete the task and errors made.

In Trail Making Test A, a longer completion time and higher number of errors can indicate difficulties with processing speed and attention.

In Trail Making Test B, a longer completion time and a higher number of errors on Trail Making Test B, compared to Trail Making Test A, can indicate difficulties with cognitive flexibility, mental shifting, and attention.
From baseline to 8-weeks
Change in selective attention using the Stroop Test
Time Frame: From baseline to 8-weeks
This cognitive task measures the time to complete the task and errors made. A longer completion time and a higher number of errors can indicate difficulty with selective attention and mental flexibility.
From baseline to 8-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in suicidal ideation using the Beck Scale for Suicide Ideation (BSSI)
Time Frame: From baseline to 8-weeks
A 21-item self-report scale that quantifies suicidal ideation. The BSSI is a Likert-style questionnaire, where each item is rated on a scale from 0 to 3, with higher scores indicating a greater severity of suicidal thoughts and behaviours. The minimum possible score on the BSSI is 0, which would indicate the absence of suicidal ideation. The maximum possible score is 63, which would indicate a high level of severity of suicidal thoughts and behaviours.
From baseline to 8-weeks
Changes in affect using the Positive and negative affect schedule - short form (PNAS-SF)
Time Frame: From baseline to 8-weeks

A 10-item scale to assess the experience of positive and negative emotions/feelings. Each item is rated on a 5-point Likert scale, ranging from 1 (very slightly or not at all) to 5 (extremely).

The minimum possible score on the PNAS-SF for positive affect is 10, which would indicate the absence of positive affect. The maximum possible score is 50, which would indicate a high level of positive affect.

The minimum possible score on the PNAS-SF for negative affect is 10, which would indicate the absence of negative affect. The maximum possible score is 50, which would indicate a high level of negative affect.
From baseline to 8-weeks
Changes in depression symptoms using the Quick Inventory of Depressive Symptomatology - self-report (QIDS-SR).
Time Frame: From baseline to 8-weeks

A 16-item validated depression scale. Each item is rated on a 4-point Likert scale, ranging from 0 (not at all) to 3 (severe).

The minimum possible score on the QID-SR is 0, which would indicate the absence of depression. The maximum possible score is 48, which would indicate a high level of depression severity.
From baseline to 8-weeks
Changes in quality of life using the Quality of Life Scale (QOLS)
Time Frame: From baseline to 8-weeks

A validated 16-item scale to assess quality of life. Each item is rated on a 7-point Likert scale , ranging from 1 (terrible) to 7 (delighted).

The minimum possible score on the QOLS is 16, which would indicate poor quality of life. The maximum possible score is 112, which would indicate excellent quality of life.
From baseline to 8-weeks
Feasibility and acceptability of music-based cognitive training
Time Frame: From baseline to 8-weeks
Feasibility and Acceptability survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the music-based cognitive training intervention.
From baseline to 8-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Sakina Rizvi, PhD,MACP,RP, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2023

Primary Completion (Actual)

May 2, 2024

Study Completion (Actual)

May 2, 2024

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBCT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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