An interventional study of Rhythmic Sensory Stimulation in Major Depressive Disorder, sponsored by University Health Network, Toronto. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
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Exclusion Criteria:
Participants in this group will undertake 30 minutes of daily Rhythmic Sensory Stimulation, for 5 day per week, for a total of 5 weeks. The stimulation consists of specially composed relaxing music tracks embedded with gamma frequency sounds of 30-70 Hz range. The intervention is conducted at the participant's home using a portable device called Sound Oasis Vibroacoustic Therapy System (VTS) 1000 unit. This device is a low-voltage consumer product device that has built in low frequency (subwoofer-type) speakers. The low frequency sounds played by the subwoofer speaker is experienced as vibrotactile vibration that is synchronized with the relaxing musical track.
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.
Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline
Clinical response (≥ 50% reduction in MADRS scores from baseline)
Time frame: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)
No study locations are listed for this record.
Plan to share: Yes — Data will be stored and shared through Ontario Brain Institute platform (BRAIN-Code).
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto