NCT05694156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

August 17, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2024

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

December 27, 2022

Last Update Submit

February 27, 2025

Conditions

Keywords

music-based interventioncognitiondepression

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Change in suicidal ideation using the Beck Scale for Suicide Ideation (BSSI)

    From baseline to 8-weeks

  • Changes in affect using the Positive and negative affect schedule - short form (PNAS-SF)

    From baseline to 8-weeks

  • Changes in depression symptoms using the Quick Inventory of Depressive Symptomatology - self-report (QIDS-SR).

    From baseline to 8-weeks

  • Changes in quality of life using the Quality of Life Scale (QOLS)

    From baseline to 8-weeks

  • Feasibility and acceptability of music-based cognitive training

    From baseline to 8-weeks

Study Arms (1)

Music-based cognitive training

EXPERIMENTAL

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

Interventions

8-week music-based cognitive training

Music-based cognitive training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1M8, Canada

Location

Related Publications (13)

  • Schoonees R, de Klerk JN, Murphy GP. The effect of prolactin on organ weights and zinc-65 uptake in male baboons. J Surg Oncol. 1970;2(2):103-6. doi: 10.1002/jso.2930020204. No abstract available.

    PMID: 4999943BACKGROUND
  • Pan Z, Park C, Brietzke E, Zuckerman H, Rong C, Mansur RB, Fus D, Subramaniapillai M, Lee Y, McIntyre RS. Cognitive impairment in major depressive disorder. CNS Spectr. 2019 Feb;24(1):22-29. doi: 10.1017/S1092852918001207. Epub 2018 Nov 23.

    PMID: 30468135BACKGROUND
  • McIntyre RS, Soczynska JZ, Woldeyohannes HO, Alsuwaidan MT, Cha DS, Carvalho AF, Jerrell JM, Dale RM, Gallaugher LA, Muzina DJ, Kennedy SH. The impact of cognitive impairment on perceived workforce performance: results from the International Mood Disorders Collaborative Project. Compr Psychiatry. 2015 Jan;56:279-82. doi: 10.1016/j.comppsych.2014.08.051. Epub 2014 Aug 23.

    PMID: 25439523BACKGROUND
  • Thaut MH, Gardiner JC, Holmberg D, Horwitz J, Kent L, Andrews G, Donelan B, McIntosh GR. Neurologic music therapy improves executive function and emotional adjustment in traumatic brain injury rehabilitation. Ann N Y Acad Sci. 2009 Jul;1169:406-16. doi: 10.1111/j.1749-6632.2009.04585.x.

    PMID: 19673815BACKGROUND
  • Hsu WC, Lai HL. Effects of music on major depression in psychiatric inpatients. Arch Psychiatr Nurs. 2004 Oct;18(5):193-9. doi: 10.1016/j.apnu.2004.07.007.

    PMID: 15529285BACKGROUND
  • Keilp JG, Gorlyn M, Russell M, Oquendo MA, Burke AK, Harkavy-Friedman J, Mann JJ. Neuropsychological function and suicidal behavior: attention control, memory and executive dysfunction in suicide attempt. Psychol Med. 2013 Mar;43(3):539-51. doi: 10.1017/S0033291712001419. Epub 2012 Jul 10.

    PMID: 22781400BACKGROUND
  • Lam RW, Kennedy SH, Mclntyre RS, Khullar A. Cognitive dysfunction in major depressive disorder: effects on psychosocial functioning and implications for treatment. Can J Psychiatry. 2014 Dec;59(12):649-54. doi: 10.1177/070674371405901206. No abstract available.

    PMID: 25702365BACKGROUND
  • Strait DL, Kraus N. Can you hear me now? Musical training shapes functional brain networks for selective auditory attention and hearing speech in noise. Front Psychol. 2011 Jun 13;2:113. doi: 10.3389/fpsyg.2011.00113. eCollection 2011.

    PMID: 21716636BACKGROUND
  • Strait DL, Slater J, O'Connell S, Kraus N. Music training relates to the development of neural mechanisms of selective auditory attention. Dev Cogn Neurosci. 2015 Apr;12:94-104. doi: 10.1016/j.dcn.2015.01.001. Epub 2015 Jan 13.

    PMID: 25660985BACKGROUND
  • Thaut MH, McIntosh GC, Hoemberg V. Neurobiological foundations of neurologic music therapy: rhythmic entrainment and the motor system. Front Psychol. 2015 Feb 18;5:1185. doi: 10.3389/fpsyg.2014.01185. eCollection 2014.

    PMID: 25774137BACKGROUND
  • Zatorre RJ. Musical pleasure and reward: mechanisms and dysfunction. Ann N Y Acad Sci. 2015 Mar;1337:202-11. doi: 10.1111/nyas.12677.

    PMID: 25773636BACKGROUND
  • Culpepper L, Lam RW, McIntyre RS. Cognitive Impairment in Patients With Depression: Awareness, Assessment, and Management. J Clin Psychiatry. 2017 Nov/Dec;78(9):1383-1394. doi: 10.4088/JCP.tk16043ah5c.

    PMID: 29345866BACKGROUND
  • Knight MJ, Baune BT. Executive Subdomains Are Differentially Associated With Psychosocial Outcomes in Major Depressive Disorder. Front Psychiatry. 2018 Jul 10;9:309. doi: 10.3389/fpsyt.2018.00309. eCollection 2018.

    PMID: 30042703BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorCognitive DysfunctionSuicideDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersCognition DisordersNeurocognitive DisordersSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Sakina Rizvi, PhD,MACP,RP

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 23, 2023

Study Start

August 17, 2023

Primary Completion

May 2, 2024

Study Completion

May 2, 2024

Last Updated

March 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations