The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Freespira Breathing System.
- Who it may be relevant to
- Registry conditions: Anxiety, Panic Disorder. Basic parameters: 9 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of a Biofeedback Breathing System for Anxiety and Panic Disorders
Overview
This study will test the efficiency of the Freespira Breathing System in youth.
Detailed description
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.
Interventions
- Device Freespira Breathing System
Over an 8-week period the efficacy of the FBS system in youth will be tested, with those in the randomized active device group. The control group will not receive the device until completion of the 8 week baseline.
Primary outcome measures
- Screen for Child Anxiety Related Disorders (SCARED) scale score [Time frame: 8-weeks]
Secondary outcome measures (12)
- SCARED anxiety scale score [Time frame: Baseline]
- SCARED anxiety scale score [Time frame: Week 4 Follow Up]
- SCARED anxiety scale score [Time frame: Week 8 Follow Up]
- SCARED anxiety scale score [Time frame: 6-month Follow Up]
- SCARED anxiety scale score [Time frame: 12-month Follow Up]
- End-tidal carbon dioxide (CO2) [Time frame: 4 weeks]
- Respiratory rate level [Time frame: 4 weeks]
- Panic Disorder Severity Scale for Adolescents (PDSS-A) [Time frame: Baseline]
- Panic Disorder Severity Scale for Adolescents (PDSS-A) [Time frame: Week 4 Follow Up]
- Panic Disorder Severity Scale for Adolescents (PDSS-A) [Time frame: Week 8 Follow Up]
- Panic Disorder Severity Scale for Adolescents (PDSS-A) [Time frame: 6-Month Follow Up]
- Panic Disorder Severity Scale for Adolescents (PDSS-A) [Time frame: 12 month Follow Up]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Johns Hopkins University — Baltimore
Identifiers
NCT: NCT02998502 · IRB00097094