Music-based Cognitive Training for Depression

Overseen By Sakina Rizvi, PhD,MACP,RP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Cognitive impairment, Active psychosis, Hearing impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist individuals with major depressive disorder through music-based cognitive training, also known as Neurologic Music Therapy or Music Therapy. The aim is to enhance attention and decision-making skills, which often decline with more episodes of depression. The sessions use music to exercise the brain, helping individuals improve focus and problem-solving abilities. It suits those diagnosed with major depressive disorder, who have had recent suicidal thoughts, and are currently in stable mental health treatment. As an unphased trial, this study provides a unique opportunity to explore innovative therapy options that could enhance mental health treatment.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop taking your current medications. In fact, you need to have stable medication use for more than 4 weeks to be eligible.

What prior data suggests that this music-based cognitive training is safe for individuals with depression?

Research has shown that neurologic music therapy, which includes music-based brain exercises, can improve thinking skills. However, limited information exists on its safety specifically for treating depression. Since it involves listening to and interacting with music, it is generally considered safe. Some studies have found that music therapy can lower stress and anxiety in people with depression, suggesting its safety. However, the overall quality of studies on using music to treat depression is considered low. While it appears safe, more research is needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for depression that often rely on medication or talk therapy, music-based cognitive training offers a novel approach by using music to directly engage cognitive processes. This treatment leverages two Neurologic Music Therapy techniques, Musical Attention Control Training and Musical Executive Function Training, to enhance attention, flexibility, problem-solving, and creativity. Researchers are excited about this method because it taps into the brain's auditory pathways, potentially offering an engaging and non-invasive alternative or complement to existing therapies.

What evidence suggests that music-based cognitive training is effective for depression?

Research has shown that music therapy can help reduce symptoms of depression. One study found that music therapy significantly lowered depression levels over several weeks. Other research supports that music therapy can boost mood, reduce anxiety, and improve sleep quality. Specifically, Neurologic Music Therapy (NMT) techniques, which include exercises for focus and decision-making, have enhanced thinking skills in people with major depression. This trial will evaluate music-based cognitive training, derived from NMT techniques, as a promising way to address depression and improve mental health. ^{1 2 6 7 8}

Who Is on the Research Team?

Sakina Rizvi, PhD,MACP,RP

Principal Investigator

Unity Health Toronto

Are You a Good Fit for This Trial?

This trial is for adults with Major Depressive Disorder (MDD) who've had over 12 psychotherapy sessions, can engage in English-language music-based cognitive training, have stable medication use for more than 4 weeks, and are experiencing suicidal thoughts. It's not suitable for those with active psychosis, severe mood issues needing urgent care, prior recent music therapy or lessons, or hearing problems.

Inclusion Criteria

I understand the study and can agree to participate.

Experiencing suicidal ideation in the past week (Beck Scale for Suicide Ideation >10)

Stable medication use > 4 weeks

Exclusion Criteria

The presence of active psychosis

Private music lessons for a period of 1 year prior to study

Unwilling or unable to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 weeks of music-based cognitive training sessions derived from Neurologic Music Therapy techniques to improve cognitive function

8 weeks

Follow-up

Participants are monitored for changes in cognitive function, affect, suicidal ideation, depression symptoms, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Music-based cognitive training

Trial Overview

The study tests an 8-week program of music-based cognitive training designed to improve attention and executive function in adults with MDD. The training uses techniques from Neurologic Music Therapy (NMT) aimed at addressing cognitive deficits that worsen with depression episodes.

How Is the Trial Designed?

Group I: Music-based cognitive training Experimental Treatment 1 Intervention

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.

Music-based cognitive training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Music Therapy for:

• Anxiety
• Depression
• Stress management
• Cognitive function improvement

Approved in European Union as Music Therapy for:

• Depression
• Anxiety disorders
• Stress-related disorders
• Cognitive rehabilitation

Approved in Canada as Music Therapy for:

• Mental health conditions
• Depression
• Anxiety
• Cognitive function enhancement

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Published Research Related to This Trial

In a study involving 56 participants, including 26 patients with treatment-resistant depression (TRD), ketamine infusions were found to significantly enhance belief updating after receiving good news compared to bad news, indicating a cognitive effect that may contribute to its rapid antidepressant response.

The study revealed that ketamine treatment led to asymmetrical learning rates, where patients updated their beliefs more positively after good news, which was linked to early improvements in depression symptoms, suggesting potential for integrating ketamine with psychotherapy for mood disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Early Ketamine Effects on Belief-Updating Biases in Patients With Treatment-Resistant Depression. Bottemanne, H., Morlaas, O., Claret, A., et al.[2022]

Participants with brain injuries who underwent four sessions of neurologic music therapy (NMT) showed significant improvements in executive function and emotional adjustment, along with reductions in depression, anxiety, and sensation seeking.

In contrast, control participants who rested instead of receiving NMT experienced declines in memory and positive affect, highlighting the potential benefits of NMT for cognitive and emotional rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic music therapy improves executive function and emotional adjustment in traumatic brain injury rehabilitation. Thaut, MH., Gardiner, JC., Holmberg, D., et al.[2009]

In a study involving 20 patients with major depression, intranasal ketamine (50 mg) demonstrated significant improvement in depressive symptoms within 24 hours compared to a placebo, with 44% of patients responding positively to the treatment.

The treatment was well tolerated, showing minimal adverse effects such as psychosis or dissociation, and did not cause significant changes in vital signs, suggesting it could be a safe option for patients with treatment-resistant depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of intranasal ketamine in major depressive disorder. Lapidus, KA., Levitch, CF., Perez, AM., et al.[2022]

Clinical trials over the past 15 years have explored the use of intravenous ketamine for treating depression, but many questions about its effectiveness and safety remain unanswered.

Concerns about ketamine include its potential for adverse effects, abuse, and addiction, which means its use for depression is still primarily limited to research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should ketamine be used for the clinical treatment of depression? Arunogiri, S., Keks, NA., Hope, J.[2018]

Intravenous (IV) racemic ketamine has strong evidence (Level 1) for its rapid antidepressant effects in adults with treatment-resistant depression (TRD), making it a viable third-line treatment option.

While single-dose IV ketamine is effective, the evidence for multiple infusions is limited (Level 3), and potential adverse effects such as dissociative symptoms and hypertension must be carefully monitored, especially for non-IV formulations which have even less evidence supporting their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Canadian Network for Mood and Anxiety Treatments (CANMAT) Task Force Recommendations for the Use of Racemic Ketamine in Adults with Major Depressive Disorder: Recommandations Du Groupe De Travail Du Réseau Canadien Pour Les Traitements De L'humeur Et De L'anxiété (Canmat) Concernant L'utilisation De La Kétamine Racémique Chez Les Adultes Souffrant De Trouble Dépressif Majeur. Swainson, J., McGirr, A., Blier, P., et al.[2021]

Neurologic music therapy (NMT), specifically using rhythmic auditory stimulation (RAS), has been shown to significantly improve gait and balance in elderly patients with Parkinson's disease and stroke, based on a review of 8 randomized controlled trials.

The studies indicate that RAS not only enhances mobility but also reduces the risk of falls in Parkinson's disease patients, highlighting its potential as an effective non-pharmacological rehabilitation technique for geriatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic Music Therapy in Geriatric Rehabilitation: A Systematic Review. Rusowicz, J., Szczepańska-Gieracha, J., Kiper, P.[2022]

Music therapy is increasingly recognized as a vital component in neurosurgical rehabilitation, focusing on various aspects of human processing such as auditory, motor, and cognitive functions, which can positively influence both musical and non-musical behaviors.

The therapy is applied in diverse clinical scenarios, including engaging patients in vegetative states, aiding communication in those with aphasia, and improving cognitive and spatial perception in patients with neuropsychological disorders, demonstrating its broad therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Merging pathways: music therapy in neurosurgical rehabilitation. Gilbertson, S., Ischebeck, W.[2019]

Neuroscientific research is reshaping the understanding of music therapy, highlighting how music affects brain function and behavior, which could enhance its effectiveness in treatment.

This shift from a social science perspective to a neuroscience-guided approach may elevate music therapy from a supplementary treatment to a primary therapeutic modality in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future of music in therapy and medicine. Thaut, MH.[2006]

A two-day per week Neurologic Music Therapy (NMT) service over 24 months was found to be feasible and well-accepted by patients, relatives, and staff, with high helpfulness ratings (patients: 3.34, relatives: 3.83, staff: 3.85 on a scale of 1 to 4).

Patients showed a non-significant trend towards improved mood after sessions, with a reduction in feelings of sadness and an increase in happiness, suggesting that NMT may enhance engagement in rehabilitation for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic music therapy in multidisciplinary acute stroke rehabilitation: Could it be feasible and helpful? Street, A., Zhang, J., Pethers, S., et al.[2021]

Intranasal (IN) ketamine treatment for depression was found to have significant acute side effects, including cardiovascular and neurological issues, at doses lower than 100 mg, leading to poor tolerability among participants.

The study indicated that the formulation and delivery method of IN ketamine were not effective, as participants struggled with self-administration and experienced variable absorption, suggesting that these factors greatly influence the treatment's safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated intranasal ketamine for treatment-resistant depression - the way to go? Results from a pilot randomised controlled trial. Gálvez, V., Li, A., Huggins, C., et al.[2022]

Music therapy has been shown to have therapeutic effects across various populations, including children with autism, adults with psychiatric illnesses, and elderly patients with Alzheimer's and Parkinson's disease.

Research indicates that music therapy can improve neurological function, such as helping patients regain control over walking after brain injuries and enhancing memory and social interaction in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of music therapy in medicine]. Zárate, P., Díaz, V.[2006]

Neurologic music therapy (NMT) combined with conventional cognitive rehabilitation (CCR) significantly improved cognitive functions in patients with multiple sclerosis (MS), particularly in long-term memory and recall tasks, compared to CCR alone.

Patients receiving NMT also experienced greater improvements in emotional status, motivation, mood, and overall quality of life, suggesting that NMT can be an effective complementary treatment for enhancing cognitive rehabilitation in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrative cognitive rehabilitation using neurologic music therapy in multiple sclerosis: A pilot study. Impellizzeri, F., Leonardi, S., Latella, D., et al.[2022]

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