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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rhythmic Sensory Stimulation
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Unipolar, Depression, Depressive Disorder, Behavioural Symptoms, Mood Disorder, Adjunctive Therapy, Music Therapy, Brain Stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Rhythmic Sensory Stimulation

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline
    Clinical response (≥ 50% reduction in MADRS scores from baseline)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 11, 2016
    Last Updated
    December 11, 2017
    Sponsor
    University Health Network, Toronto
    Collaborators
    University of Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02685982
    Brief Title
    Treating Major Depressive Disorder With Music and Low-frequency Rhythmic Sensory Stimulation
    Official Title
    Examining the Effects of Music and Rhythmic Sensory Stimulation on Major Depressive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    August 2017 (Actual)
    Study Completion Date
    August 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Health Network, Toronto
    Collaborators
    University of Toronto

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    Unipolar, Depression, Depressive Disorder, Behavioural Symptoms, Mood Disorder, Adjunctive Therapy, Music Therapy, Brain Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rhythmic Sensory Stimulation
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Rhythmic Sensory Stimulation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline
    Description
    Clinical response (≥ 50% reduction in MADRS scores from baseline)
    Time Frame
    Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sidney H Kennedy, MD
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Lee Bartel, PhD
    Organizational Affiliation
    University of Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be stored and shared through Ontario Brain Institute platform (BRAIN-Code).
    Links:
    URL
    http://www.canbind.ca/
    Description
    CAN-BIND website

    Learn more about this trial

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

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