Development of Mindfulness Through Adaptive Biofeedback Methods in the Treatment of Anxiety Disorders: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
研究概览
简要总结
This randomized controlled trial compared the effectiveness of a 10-day mindfulness training program using adaptive biofeedback (BFB) versus medication therapy (escitalopram 10 mg/day) versus combined treatment (BFB + medication) in inpatients with anxiety disorders (ICD-10 F40/F41). The primary outcomes were changes in anxiety (Hamilton Anxiety Rating Scale, HARS) and mindfulness (Five Facet Mindfulness Questionnaire, FFMQ) from baseline to post-treatment and at one-month follow-up.
详细描述
This was an open-label, randomized, parallel-group study conducted at the Department of Psychotherapy of [Blinded for Review] between July 2022 and February 2025. Adult inpatients (age 19-74 years) with a first-time diagnosis of anxiety disorder according to ICD-10 codes F40 and F41 were eligible. Exclusion criteria included photosensitive epilepsy, severe cognitive impairment, exacerbation of mental illness, lack of motivation, and inability to provide informed consent.
Participants were randomly assigned (simple unrestricted randomization) to one of three groups:
BFB group (n=76): 10 daily 60-minute individual sessions of mindfulness training using the "Reacor" adaptive biofeedback system, which records physiological parameters (heart rate, EEG alpha rhythm) and converts them into real-time auditory and visual signals.
Medication therapy (MT) group (n=46): escitalopram 10 mg once daily from day 1, continued through follow-up.
Combined therapy (CT) group (n=58): both BFB training and escitalopram 10 mg/day as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First time diagnosis of anxiety disorder (ICD 10 codes F40 or F41), Inpatient at the time of enrollment, Mild to moderate functional impairment according to the International Classification of Functioning, Disability and Health (ICF), Age 19-74 years, Willing and able to provide written informed consent
- •Non-inclusion criteria:
- •Photosensitive epilepsy, Severe intellectual, attentional, or memory impairment, Exacerbation of mental illness, Lack of motivation, Unwillingness or inability to provide written consent
排除标准
- •exacerbation of a severe mental and/or somatic disease, withdrawal of consent, inability to attend one or more individual sessions, refusal to do homework, inability to complete all three assessments