Effects of 40-Hz Binaural Beat Music Combined With Rhythmic Photic Stimulation on Psychological Distress, Anxiety, Cognitive Function, and Electroencephalographic Spectral Activity in Patients With Schizophrenia Spectrum Disorders: A Sham-Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in Anxiety Severity as Measured by the Beck Anxiety Inventory (BAI)
研究概览
简要总结
This randomized, sham-controlled trial evaluated the effects of 40-Hz binaural beat music (BBM) combined with 40-Hz rhythmic photic stimulation (RPS) in adults with schizophrenia spectrum disorders. A total of 55 participants with schizophrenia or schizoaffective disorder were randomly assigned to either the BBM plus RPS group or a sham control group. Participants received 20-minute sessions three times per week for 12 consecutive weeks, for a total of 36 sessions. The primary outcome was anxiety measured using the Beck Anxiety Inventory (BAI). Secondary outcomes included psychological distress measured using the Five-item Brief Symptom Rating Scale (BSRS-5) and global cognitive function measured using the Mini-Mental State Examination (MMSE). Electroencephalographic (EEG) relative power across delta, theta, alpha, beta, and gamma frequency bands was also assessed as an exploratory physiological outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder according to DSM-5 criteria, made by a board-certified psychiatrist at least 1 year prior to enrollment.
- •Age 20 to 60 years.
- •Stable psychiatric symptoms, with no adjustment of major psychotropic medications for at least 2 consecutive months.
- •No severe hearing impairment.
- •4. Current participation in a day-care program, community rehabilitation center, or rehabilitation ward.
排除标准
- •Acute illness episode or unstable physical condition.
- •History of epilepsy or risk of seizures.
- •Substance abuse.
- •Impaired or disturbed consciousness.
结局指标
主要结局
Change in Anxiety Severity as Measured by the Beck Anxiety Inventory (BAI)
时间窗: Baseline and within 2 days after completion of the 12-week intervention
The Beck Anxiety Inventory (BAI) is a 21-item self-report measure used to assess the severity of anxiety symptoms. Each item is rated from 0 to 3, yielding a total score ranging from 0 to 63, with higher scores indicating greater anxiety severity. The primary outcome was the change in total BAI score from baseline to post-intervention.
次要结局
未报告次要终点
研究者
Yang Shang-Yu
Associate professor
National Cheng Kung University