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

NCT02685982 | Completed DMC

• 1 other identifier: 15-9799
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline

  Clinical response (≥ 50% reduction in MADRS scores from baseline)

  Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)

Study Arms (1)

Rhythmic Sensory Stimulation

EXPERIMENTAL

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

Interventions

Rhythmic Sensory Stimulation DEVICE

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.

Rhythmic Sensory Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Toronto: collaborator

Related Links

• CAN-BIND website

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Sidney H Kennedy, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Lee Bartel, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 19, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 13, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share