Treating Major Depressive Disorder With Music and Low-frequency Rhythmic Sensory Stimulation
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

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.
    

Detailed description: 
      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. Several recent
      systematic reviews have concluded that music is an effective therapeutic tool with
      significant results on improving global state, symptoms, and overall functioning, and is also
      well-accepted by patients.

      The goal of this project is to evaluate the effectiveness of music and rhythmic sensory
      stimulation with low-frequency sounds as an adjunctive therapy for depression. Through a
      systematic collection of clinical, behavioural and electrophysiological measures, the project
      also aims to determine the possible mechanisms that underlie the effects of music- and
      sound-based therapies on symptoms of MDD. In addition to measures of depression severity and
      symptoms, we are also interested in secondary behavioral measures addressing possible
      confounding variables, such as anhedonia, quality of life, and individual differences in how
      people experience reward and pleasure associated with music. These assessments will allow an
      initial investigation of the neural correlates of the therapeutic effects of music in the
      treatment of depression, which is greatly warranted to better understand the efficacy of
      music- and sound-based treatments.
    

Intervention name(s): Rhythmic Sensory Stimulation
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unipolar; Depression; Depressive Disorder; Behavioural Symptoms; Mood Disorder; Adjunctive Therapy; Music Therapy; Brain Stimulation