Clinical trial NCT05694156: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Cognitive Dysfunction
Suicide
Keywords: music-based intervention
cognition
depression
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in inhibition using the Go/No Go Task
timeFrame: From baseline to 8-weeks
measure: Change in working memory capacity using the Digit Span Forward and Backward Test
timeFrame: From baseline to 8-weeks
measure: Change in cognitive flexibility and executive control using the Shifting Attention test
timeFrame: From baseline to 8-weeks
measure: Change in visual attention and task switching using the Trail Making A and B test
timeFrame: From baseline to 8-weeks
measure: Change in selective attention using the Stroop Test
timeFrame: From baseline to 8-weeks
Secondary outcomes:
measure: Change in suicidal ideation using the Beck Scale for Suicide Ideation (BSSI)
timeFrame: From baseline to 8-weeks
measure: Changes in affect using the Positive and negative affect schedule - short form (PNAS-SF)
timeFrame: From baseline to 8-weeks
measure: Changes in depression symptoms using the Quick Inventory of Depressive Symptomatology - self-report (QIDS-SR).
timeFrame: From baseline to 8-weeks
measure: Changes in quality of life using the Quality of Life Scale (QOLS)
timeFrame: From baseline to 8-weeks
measure: Feasibility and acceptability of music-based cognitive training
timeFrame: From baseline to 8-weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Sakina Rizvi, PhD,MACP,RP
role: PRINCIPAL_INVESTIGATOR
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