The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens

Not Applicable

Completed

• Conditions: Anxiety; Panic Disorder
• Interventions: Device: Freespira Breathing System

• Registration Number: NCT02998502
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Primary Completion: 2019-12-05
• Status Verified: 2020-11
• Study Completion: 2021-02-01
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Device Group	Freespira Breathing System	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.

Primary Outcome Measures

Name	Time	Method
Screen for Child Anxiety Related Disorders (SCARED) scale score	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.

Secondary Outcome Measures

Name	Time	Method
Panic Disorder Severity Scale for Adolescents (PDSS-A)	12 month Follow Up	Panic Disorder Severity Scale for Adolescents \[PDSS-A\] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
SCARED anxiety scale score	12-month Follow Up	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.
Clinician's Global Impression scale.	Week 8 Follow Up	Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score.; This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.
End-tidal carbon dioxide (CO2)	4 weeks	End-tidal CO2 at 4 weeks Measured using Freespira breathing system 4 minutes breathing session Parameters number of millimeters per mercury.
Respiratory rate level	4 weeks	Respiratory rate at 4 weeks Measured using Freespira breathing system 4 minutes breathing session. The parameters are number of breaths per minute.
Child Yale Brown Obsessive-Compulsive Scale score	Week 8 Follow Up	Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.
Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)	Week 8	Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States