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Musical Attention Control and Executive Function Training for Adults With MDD

Primary Purpose

Major Depressive Disorder, Cognitive Dysfunction, Suicide

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Music-based cognitive training
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring music-based intervention, cognition, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Michael's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Music-based cognitive training

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in inhibition using the Go/No Go Task
This cognitive task measures response time, accuracy, commission errors, omission errors, and reaction time variability.
Change in working memory capacity using the Digit Span Forward and Backward Test
This cognitive task measures span length, correct recall, error rate, and reaction time.
Change in cognitive flexibility and executive control using the Shifting Attention test
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.
Change in visual attention and task switching using the Trail Making A and B test
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.
Change in selective attention using the Stroop Test
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.

Secondary Outcome Measures

Change in suicidal ideation using the Beck Scale for Suicide Ideation (BSSI)
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.
Changes in affect using the Positive and negative affect schedule - short form (PNAS-SF)
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.
Changes in depression symptoms using the Quick Inventory of Depressive Symptomatology - self-report (QIDS-SR).
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.
Changes in quality of life using the Quality of Life Scale (QOLS)
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.
Feasibility and acceptability of music-based cognitive training
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.

Full Information

First Posted
December 27, 2022
Last Updated
July 19, 2023
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05694156
Brief Title
Musical Attention Control and Executive Function Training for Adults With MDD
Official Title
Musical Attention Control and Executive Function Training for Adults With MDD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Cognitive Dysfunction, Suicide
Keywords
music-based intervention, cognition, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music-based cognitive training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Music-based cognitive training
Intervention Description
8-week music-based cognitive training
Primary Outcome Measure Information:
Title
Change in inhibition using the Go/No Go Task
Description
This cognitive task measures response time, accuracy, commission errors, omission errors, and reaction time variability.
Time Frame
From baseline to 8-weeks
Title
Change in working memory capacity using the Digit Span Forward and Backward Test
Description
This cognitive task measures span length, correct recall, error rate, and reaction time.
Time Frame
From baseline to 8-weeks
Title
Change in cognitive flexibility and executive control using the Shifting Attention test
Description
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.
Time Frame
From baseline to 8-weeks
Title
Change in visual attention and task switching using the Trail Making A and B test
Description
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.
Time Frame
From baseline to 8-weeks
Title
Change in selective attention using the Stroop Test
Description
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.
Time Frame
From baseline to 8-weeks
Secondary Outcome Measure Information:
Title
Change in suicidal ideation using the Beck Scale for Suicide Ideation (BSSI)
Description
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.
Time Frame
From baseline to 8-weeks
Title
Changes in affect using the Positive and negative affect schedule - short form (PNAS-SF)
Description
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.
Time Frame
From baseline to 8-weeks
Title
Changes in depression symptoms using the Quick Inventory of Depressive Symptomatology - self-report (QIDS-SR).
Description
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.
Time Frame
From baseline to 8-weeks
Title
Changes in quality of life using the Quality of Life Scale (QOLS)
Description
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.
Time Frame
From baseline to 8-weeks
Title
Feasibility and acceptability of music-based cognitive training
Description
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.
Time Frame
From baseline to 8-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sakina Rizvi, PhD,MACP,RP
Phone
416-864-6060
Ext
6489
Email
rizvisa@smh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sakina Rizvi, PhD,MACP,RP
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1M8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Tan, MA
Email
melissa.tan@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Sakina Rizvi, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27616997
Citation
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Results Reference
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Citation
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Citation
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PubMed Identifier
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Citation
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Musical Attention Control and Executive Function Training for Adults With MDD

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