Binaural Beat Music Combined With Rhythmic Photic Stimulation on Depression

NCT ID: NCT06540157

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-07-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

BBM and RPS group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Sham group

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

Group Type: SHAM_COMPARATOR

Sham group

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Sham group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cheng Kung University

OTHER

Sponsor Role: lead

Responsible Party

Yang Shang-Yu

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shang-Yu Yang, PhD

Role: STUDY_CHAIR

Asia University

Locations

Asia Univeraity

Taichung, WuFeng, Taiwan

Countries

Taiwan

Other Identifiers

Asia0725

Identifier Type: -

Identifier Source: org_study_id