Clinical trial NCT06540157: Binaural Beat Music Combined With Rhythmic Photic Stimulation on Depression
Official title: Investigating the Effectiveness of Binaural Beat Music Combined With Rhythmic Photic Stimulation on Depression, Quality of Life, and Heart Rate Variability in Elderly Patients With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for this study were:

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:

* Exclusion criteria included:

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.

Primary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: 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.
measure: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 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.
measure: HRV analyzer
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia Univeraity
state: WuFeng
Study officials:
affiliation: Asia University
name: Shang-Yu Yang, PhD
role: STUDY_CHAIR
References: