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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Music-based Cognitive Training for Depression is an effective treatment?

The available research shows that Music-based Cognitive Training, also known as Neurologic Music Therapy (NMT), can be effective in improving mood and emotional adjustment. For example, one study found that NMT helped people with brain injuries improve their emotional adjustment and reduce feelings of depression and anxiety. Another study on stroke patients showed that NMT was considered helpful by patients, their relatives, and staff, and it improved patients' mood by making them feel happier. While these studies focus on conditions like brain injuries and strokes, they suggest that NMT can positively impact mood and emotional well-being, which is relevant for treating depression. ^{1 2 3 4 5}

What safety data exists for music-based cognitive training for depression?

The provided research does not contain safety data for music-based cognitive training, neurologic music therapy, or music therapy for depression. The studies focus on ketamine treatments for depression. ^{6 7 8 9 10}

Is music-based cognitive training a promising treatment for depression?

Yes, music-based cognitive training, also known as Neurologic Music Therapy, is a promising treatment for depression. It has been shown to improve emotional adjustment and reduce depression symptoms by using music to enhance brain function and emotional well-being. ^{2 3 5 11 12}

Research Team

Sakina Rizvi, PhD,MACP,RP

Principal Investigator

Unity Health Toronto

Eligibility Criteria

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 can participate in English-speaking music cognitive training.

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

Stable medication use > 4 weeks

Exclusion Criteria

I have hearing loss.

Unwilling or unable to provide informed consent

The presence of active psychosis

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Neurologic music therapy in multidisciplinary acute stroke rehabilitation: Could it be feasible and helpful? [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Neurologic music therapy improves executive function and emotional adjustment in traumatic brain injury rehabilitation. [2009]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Neurologic Music Therapy in Geriatric Rehabilitation: A Systematic Review. [2022]

4. Chile pubmed.ncbi.nlm.nih.gov

[Application of music therapy in medicine]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

An integrative cognitive rehabilitation using neurologic music therapy in multiple sclerosis: A pilot study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Repeated intranasal ketamine for treatment-resistant depression - the way to go? Results from a pilot randomised controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of intranasal ketamine in major depressive disorder. [2022]

8. United States 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Should ketamine be used for the clinical treatment of depression? [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Early Ketamine Effects on Belief-Updating Biases in Patients With Treatment-Resistant Depression. [2022]

11. Austria pubmed.ncbi.nlm.nih.gov

Merging pathways: music therapy in neurosurgical rehabilitation. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

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