Binaural Beat Music Combined With Rhythmic Photic Stimulation on Depression
NCT Number: NCT06540157
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: OTHER: Binaural Beat Music (BBM) Combined with Rhythmic Photic Stimulation (RPS)|OTHER: Sham group
Sponsor: National Cheng Kung University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-02-01
Completion Date: 2024-07-25
Locations: Asia Univeraity, Taichung, WuFeng, 41354, Taiwan

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.

Primary Outcome Measures: 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.