Musical Attention Control and Executive Function Training for Adults With MDD

Sponsor
Unity Health Toronto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05694156
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Music-based cognitive training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Musical Attention Control and Executive Function Training for Adults With MDD
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in cognitive function using neurocognitive tasks assessing areas of attention and executive function. [From baseline to 8-weeks]

    Standardised tests that assess memory, processing speed, attention, and executive function will be used. Go/No Go Task Digit Span Forward and Backward Shifting attention test Trail Making A and B Stroop Test

Secondary Outcome Measures

  1. Change in suicidal ideation using the Beck Scale for Suicide Ideation [From baseline to 8-weeks]

    A 21-item self-report scale that quantifies suicidal ideation.

  2. Changes in affect using the Positive and negative affect schedule - short form (PNAS-SF) [From baseline to 8-weeks]

    A 10-item scale to assess the experience of positive and negative emotions/feelings.

  3. Changes in depression symptoms using the Quick Inventory of Depressive Symptomatology - self-report (QIDS-SR). [From baseline to 8-weeks]

    A 16-item validated depression scale.

  4. Changes in quality of life using the Quality of Life Scale (QOLS) [From baseline to 8-weeks]

    A validated 16-item scale to assess quality of life

  5. Feasibility and acceptability of music-based cognitive training [From baseline to 8-weeks]

    A self-report questionnaire created in-house to address participant feedback on their experiences with specific aspects of music-based cognitive training.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Michael's Hospital Toronto Ontario Canada M5B 1M8

Sponsors and Collaborators

  • Unity Health Toronto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Unity Health Toronto
ClinicalTrials.gov Identifier:
NCT05694156
Other Study ID Numbers:
  • MBCT-01
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Unity Health Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2023