Clinical trial NCT02998502: The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens
Official title: Efficacy of a Biofeedback Breathing System for Anxiety and Panic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Panic Disorder
Keywords: Obsessive Compulsive Disorder (OCD)
Anxiety
Pediatrics
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Palo Alto Health Sciences, Inc.
First posted: 2016-12-20
Enrollment: 73
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Screen for Child Anxiety Related Disorders (SCARED) scale score
timeFrame: 8-weeks
Secondary outcomes:
measure: SCARED anxiety scale score
timeFrame: Baseline
measure: SCARED anxiety scale score
timeFrame: Week 4 Follow Up
measure: SCARED anxiety scale score
timeFrame: Week 8 Follow Up
measure: SCARED anxiety scale score
timeFrame: 6-month Follow Up
measure: SCARED anxiety scale score
timeFrame: 12-month Follow Up
measure: End-tidal carbon dioxide (CO2)
timeFrame: 4 weeks
measure: Respiratory rate level
timeFrame: 4 weeks
measure: Panic Disorder Severity Scale for Adolescents (PDSS-A)
timeFrame: Baseline
measure: Panic Disorder Severity Scale for Adolescents (PDSS-A)
timeFrame: Week 4 Follow Up
measure: Panic Disorder Severity Scale for Adolescents (PDSS-A)
timeFrame: Week 8 Follow Up
measure: Panic Disorder Severity Scale for Adolescents (PDSS-A)
timeFrame: 6-Month Follow Up
measure: Panic Disorder Severity Scale for Adolescents (PDSS-A)
timeFrame: 12 month Follow Up
measure: Clinician's Global Impression scale.
timeFrame: Baseline
measure: Clinician's Global Impression scale.
timeFrame: Week 4 Follow Up
measure: Clinician's Global Impression scale.
timeFrame: Week 8 Follow Up
measure: Child Yale Brown Obsessive-Compulsive Scale score
timeFrame: Baseline
measure: Child Yale Brown Obsessive-Compulsive Scale score
timeFrame: Week 4 Follow Up
measure: Child Yale Brown Obsessive-Compulsive Scale score
timeFrame: Week 8 Follow Up
measure: Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)
timeFrame: Week 8
Other outcomes:
measure: Child Sheehan Disability Scale (CSDS)
timeFrame: Baseline
measure: Child Sheehan Disability Scale (CSDS)
timeFrame: Week 4 Follow Up
measure: Child Sheehan Disability Scale (CSDS)
timeFrame: Week 8 Follow Up
measure: Children's Depression Inventory ( CDI2)
timeFrame: Baseline
measure: Children's Depression Inventory ( CDI2)
timeFrame: Week 4 Follow Up
measure: Children's Depression Inventory ( CDI2)
timeFrame: Week 8 Follow Up
measure: Childhood Anxiety Sensitivity Index (CASI)
timeFrame: Baseline
measure: Childhood Anxiety Sensitivity Index (CASI)
timeFrame: Week 4 Follow Up
measure: Childhood Anxiety Sensitivity Index (CASI)
timeFrame: Week 8 Follow Up
measure: Junior Temperament and Character Inventory (JTCI)
timeFrame: Baseline
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Baseline
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Week 4 Follow Up
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Week 8 Follow Up
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: 12 month Follow Up
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Marco Grados, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: