Binaural Beat Music Combined With Rhythmic Photic Stimulation on Depression

NCT06540157 | Completed

• 1 other identifier: Asia0725
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Previous studies have suggested that non-pharmacological treatments, such as binaural beat music (BBM) and rhythmic photic stimulation (RPS), may help improve depressive symptoms and enhance quality of life. However, their effectiveness in elderly patients with depression remains unclear. Objectives: This study aims to investigate the effects of combining BBM and RPS on improving depression, quality of life, and heart rate variability (HRV) in elderly patients with depression. Methods: This study was conducted as a single-blind randomized controlled trial. Forty-eight elderly patients with depression were recruited from a long-term care institution in Taiwan and randomly assigned to either the BBM and RPS group or the Sham group. Participants received 20 minutes of intervention daily, Monday to Friday, for 12 consecutive weeks. During the intervention, participants in the BBM and RPS group listened to 10Hz BBM (embedded with classic old songs) and wore RPS glasses that provided 10Hz light stimulation. In contrast, participants in the Sham group listened to classic old songs and wore RPS glasses without the 10Hz light stimulation.

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

• Beck Depression Inventory (BDI)

  There were 21 questions in the BDI, and a self-rated method was used for participants to fill in their thoughts in the last 2 weeks. A 4-point Likert scale was used. The score range of each question was 0-3 points. A total score of 0-12 points was normal, 14-19 points was mild depression, 20-28 points was moderate depression, and 29-63 points was severe depression.

  On Day 84 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 10 minutes.

• World Health Organization Quality of Life-BREF (WHOQOL-BREF)

  The Taiwanese version of WHOQOL-BREF measured quality of life, containing 28 items scored on a 5-point Likert scale. It covered four domains: Physical Health (7 items), Psychological Health (6 items), Social Relationships (4 items), and Environment (9 items). Scores ranged from 4 to 20 points, with higher scores indicating better quality of life.

  On Day 84 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 10 minutes.

• HRV analyzer

  HRV (Heart Rate Variability) Measurements: Mean heart rate (bpm): This measures the average number of heartbeats per minute. SDNN (ms): Standard deviation of all RR intervals, representing the physiological health of the autonomic nervous system. A higher SDNN indicates better physiological health. nLF (Normalized Low Frequency, ms²): Reflects sympathetic nervous activity. A higher value indicates greater activity. nHF (Normalized High Frequency, ms²): Reflects parasympathetic nervous activity. A higher value indicates greater activity. LF/HF (ratio): A marker reflecting the balance between sympathetic and parasympathetic nervous activity.

  On Day 84 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 10 minutes.

Study Arms (2)

BBM and RPS group

EXPERIMENTAL

All participants received 20-minute interventions daily from Monday to Friday for 12 weeks.

Other: Binaural Beat Music (BBM) Combined with Rhythmic Photic Stimulation (RPS)

Sham group

SHAM COMPARATOR

All participants received 20-minute interventions daily from Monday to Friday for 12 weeks.

Other: Sham group

Interventions

Binaural Beat Music (BBM) Combined with Rhythmic Photic Stimulation (RPS) OTHER

Participants rested on a chair for 10 minutes before the intervention. Participants wore over-ear stereo headphones and RPS glasses, receiving 20 minutes of 10Hz BBM (embedded with classic old songs as mask music) and RPS. The BBM and RPS glasses were purchased from George Szeless's mindLightz.

BBM and RPS group

Sham group OTHER

Participants rested on a chair for 10 minutes before the intervention. Participants wore the same headphones and RPS glasses as the BBM and RPS group but listened to classic Taiwanese old songs without the 10Hz light stimulation from the RPS glasses.

Sham group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• A) Diagnosed with major depressive disorder by a psychiatrist and stable for more than six months; B) Aged 65 and above; C) No cognitive impairment, with a Mini-Mental State Examination (MMSE) score above 24 and able to understand the questionnaire content; D) No severe physical illnesses and no significant hearing impairments; E) Not using antidepressants within three months before and during the intervention.

You may not qualify if:

• A) History of mixed psychiatric disorders, including schizophrenia, bipolar disorder, and dementia; B) Experiencing acute illness (or pain) and unstable physiological conditions; C) History of epilepsy or potential for seizures; D) Substance abuse; E) Participation in electroconvulsive therapy or transcranial electrical stimulation within one month before and during the intervention.

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

Asia Univeraity

Taichung, WuFeng, 41354, Taiwan

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Shang-Yu Yang, PhD

  Asia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 6, 2024
• Study Start: February 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 25, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

TW (1)