Treating Major Depressive Disorder With Music and Low-frequency Rhythmic Sensory Stimulation

NCT02685982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-12-13

No results posted yet for this study

Summary

Major depressive disorder (MDD) is a highly prevalent and disabling disorder associated with persistent low mood, loss of the capacity to experience pleasure (i.e. anhedonia), reduced social functioning, and impaired quality of life. MDD is estimated to affect approximately 2% of Canadian women and 1% of Canadian men at any point in time. The World Health Organization affirms that depression is the leading cause of disability worldwide, with increasing global economic impact.

Standard treatments for depression include basic psychosocial support combined with antidepressant medication or psychotherapy. It has been observed, however, that only 50% of individuals respond to psychological treatment, and only 30-40% of patients achieve full remission after initial treatment with antidepressants. Music- and sound-related therapies have the potential to serve as adjuncts to, or facilitators of, medication.

In this study we will examine the effectiveness of a new therapeutic tool, known as Rhythmic Sensory Stimulation, as an adjunctive treatment for Major Depressive Disorder. Rhythmic Sensory Stimulation is a non-invasive brain stimulation technique that uses periodic pulses of light, sound, or tactile stimulus, to induce changes in the patterns of brain activity. Participants in this study will undertake 30 minutes of daily music intervention self-administered at home, for 5 days per week, for a total of 5 weeks. We will assess depression symptoms, sleep quality, quality of life, and brain activity pre- and post-treatment.

The results of the present study will help to better understand the effectiveness of Rhythmic Sensory Stimulation to the treatment of mood disorders, and contribute to the development of future studies to investigate the neural driving effects of therapies based on Rhythmic Sensory Stimulation.

Conditions

Interventions

DEVICE

Rhythmic Sensory Stimulation

The stimulation consists of 30 minutes of daily stimulation with specially composed relaxing music tracks embedded with gamma frequency sounds of 30-70 Hz range. In this study, the stimuli will be delivered with a portable sound device called Sound Oasis Vibroacoustic Therapy System (VTS-1000) unit, which is a low-voltage consumer product that has two built in mid to high frequency speakers and one built in low frequency (subwoofer-type) speaker. The low frequency sounds played by the subwoofer speaker is experienced as vibrotactile vibration. Although the Intervention of Interest in this study is the Rhythmic Sensory Stimulation with low-frequency sounds, the efficacy of the Sound Oasis VTS-1000 device to deliver the intervention will also be subject to observation.

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Sidney H Kennedy, MD · University Health Network, Toronto

  • Lee Bartel, PhD · University of Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-08-31
Completion
2017-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685982 on ClinicalTrials.gov