Musical Attention Control and Executive Function Training for Adults With MDD

Study Overview
=================
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.

Official Title
-----------------
Musical Attention Control and Executive Function Training for Adults With MDD

Conditions
-----------------
Major Depressive Disorder, Cognitive Dysfunction, Suicide

Intervention / Treatment
-----------------
* Other: Music-based cognitive training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music-based cognitive training<br>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<br>* 8-week music-based cognitive training<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inhibition using the Go/No Go Task | 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 | 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 | 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 | 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 | 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) | 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) | 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). | 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) | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognition, music-based intervention, depression