Efficacy of a Biofeedback Breathing System for Anxiety and Panic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Screen for Child Anxiety Related Disorders (SCARED) scale score
研究概览
简要总结
This study will test the efficiency of the Freespira Breathing System in youth.
详细描述
The Freespira Breathing System (FBS; www.freespira.com) developed by Palo Alto Health Sciences, Inc, is a portable home device , and has been employed in breathing biofeedback in adults with panic disorder (PD). The FBS has now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for cognitive behavioral therapy (CBT) or lower acceptability for long-term medication use for adolescent PD.
In this pilot intervention study, the efficacy of the FBS system in youth will be tested. In children adolescents, PD itself is less common than in adults, but when present, PD is commonly associated with and/or preceded by other anxiety conditions, including generalized anxiety disorder (GAD), social phobia (SoP) and separation anxiety (SAD). Thus, in children and adolescents, the breathing biofeedback intervention for panic, should include other anxiety disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCARED score ≥ 25 + prior clinical diagnosis of an anxiety disorder
- •Participants must be 9-17 years of age
- •If on psychotropic medication(s), participant must be on a stable dose for at least one month prior to study enrollment
排除标准
- •Anxiety has occurred exclusively during a major depressive episode, psychiatric illness, dementia, intellectual disability, or brain disease
- •Currently enrolled in another device or drug study or less than 30 days has elapsed since participation in such a study
- •Currently undergoing breathing biofeedback elsewhere
- •Demonstrate evidence of severe suicidal ideation or psychosis
- •There is an active condition of asthma
研究组 & 干预措施
Control Group
The device will be given to those in the control group after 8-week baseline period.
Device Group
The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device used for breathing biofeedback in adults with PD. FBS has now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for CBT or lower acceptability for long-term medication use for adolescent PD. In this pilot intervention study, the efficacy of the FBS system in youth will be tested.
干预措施: Freespira Breathing System (Device)
结局指标
主要结局
Screen for Child Anxiety Related Disorders (SCARED) scale score
时间窗: 8-weeks
The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
次要结局
- Panic Disorder Severity Scale for Adolescents (PDSS-A)(12 month Follow Up)
- SCARED anxiety scale score(12-month Follow Up)
- Clinician's Global Impression scale.(Week 8 Follow Up)
- End-tidal carbon dioxide (CO2)(4 weeks)
- Respiratory rate level(4 weeks)
- Child Yale Brown Obsessive-Compulsive Scale score(Week 8 Follow Up)
- Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)(Week 8)
- SCARED anxiety scale score(Baseline)
- SCARED anxiety scale score(Week 4 Follow Up)
- SCARED anxiety scale score(Week 8 Follow Up)
- SCARED anxiety scale score(6-month Follow Up)
- Panic Disorder Severity Scale for Adolescents (PDSS-A)(Baseline)
- Panic Disorder Severity Scale for Adolescents (PDSS-A)(Week 4 Follow Up)
- Child Yale Brown Obsessive-Compulsive Scale score(Baseline)
- Panic Disorder Severity Scale for Adolescents (PDSS-A)(Week 8 Follow Up)
- Panic Disorder Severity Scale for Adolescents (PDSS-A)(6-Month Follow Up)
- Clinician's Global Impression scale.(Baseline)
- Clinician's Global Impression scale.(Week 4 Follow Up)
- Child Yale Brown Obsessive-Compulsive Scale score(Week 4 Follow Up)