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

• ClinicalTrials.gov Identifier: NCT02685982
• Recruitment Status: Completed
• First Posted: February 19, 2016
• Last Update Posted: December 13, 2017
• Sponsor: University Health Network, Toronto
• Collaborator: University of Toronto
• Information provided by (Responsible Party): University Health Network, Toronto

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Device: Rhythmic Sensory Stimulation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Examining the Effects of Music and Rhythmic Sensory Stimulation on Major Depressive Disorder
• Actual Study Start Date: April 2016
• Actual Primary Completion Date: August 2017
• Actual Study Completion Date: August 2017

Arms and Interventions

Arm

Intervention/treatment

Experimental: Rhythmic Sensory Stimulation; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline [ Time Frame: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) ]
   Clinical response (≥ 50% reduction in MADRS scores from baseline)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Outpatients 18 to 60 years of age.
• Meet DSM-IV-TR criteria for major depressive episode (MDE) in major depressive disorder (MDD) without psychotic features, as determined by clinician assessment.
• Episode duration > 3 months.
• MADRS score ≥ 15 (mild to severe symptoms intensity).
• Fluency in English, sufficient to complete the interviews and self-report questionnaires.
• Satisfactory hearing bilaterally based on self-report.

Exclusion Criteria:

• Any Axis I diagnosis (other than MDD), and MDD with psychotic features,that is considered the primary diagnosis.
• Fibromyalgia diagnosis (FIQR score ≥ 39).
• Bipolar-I or Bipolar-II diagnosis (HCL score ≥ 14).
• Presence of a significant Axis II diagnosis (borderline, antisocial), judged as being primary based on clinician assessment.
• High suicidal risk, defined by clinician judgment.
• Substance dependence/abuse in the past 6 months.
• Presence of significant neurological disorders, head trauma, or other unstable medical conditions.
• Acute and active inflammatory conditions, rheumatoid arthritis, osteoarthritis, autoimmune disease.
• History of epilepsy, seizures.
• Hemorrhaging or active bleeding.
• Hearing impairment.
• Thrombosis or heart diseases, including hypotension, arrhythmia, pacemaker, angina pectoris.
• Pregnant or breastfeeding.
• Recovering from recent accident with prolapsed vertebral disc, back or neck injury.
• Started psychological treatment within the past 3 months with the intent of continuing treatment.
• Patients who have changed medication or adjusted medication dosage within 4 weeks.

Contacts and Locations

Sponsors and Collaborators

University Health Network, Toronto

University of Toronto

Investigators

• Principal Investigator: Sidney H Kennedy, MD; University Health Network, Toronto
• Principal Investigator: Lee Bartel, PhD; University of Toronto

More Information

Additional Information:

CAN-BIND website 

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT02685982
• Other Study ID Numbers: 15-9799
• First Posted: February 19, 2016
• Last Update Posted: December 13, 2017
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data will be stored and shared through Ontario Brain Institute platform (BRAIN-Code).

Keywords provided by University Health Network, Toronto:

Unipolar; Depression; Depressive Disorder; Behavioural Symptoms; Mood Disorder; Adjunctive Therapy; Music Therapy; Brain Stimulation

Additional relevant MeSH terms:

Disease; Depressive Disorder; Depression; Depressive Disorder, Major; Pathologic Processes; Mood Disorders; Mental Disorders; Behavioral Symptoms