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Trial record 59 of 179 for:    "Panic Disorder"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02998502
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Palo Alto Health Sciences, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study will test the efficiency of the Freespira Breathing System in youth.

Condition or disease Intervention/treatment Phase
Anxiety Panic Disorder Device: Freespira Breathing System Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of a Biofeedback Breathing System for Anxiety and Panic Disorders
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Control Group
The device will be given to those in the control group after 8-week baseline period.



Primary Outcome Measures :
  1. Primary outcome is a score of Screen for Child Anxiety Related Disorders (SCARED) scale, the anxiety measuring scale. [ Time Frame: 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 :
  1. SCARED anxiety scale score [ Time Frame: Visit 1 ]
    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.

  2. SCARED anxiety scale score [ Time Frame: Week 4 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.

  3. SCARED anxiety scale score [ Time Frame: Week 8 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.

  4. SCARED anxiety scale score [ Time Frame: 6-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.

  5. SCARED anxiety scale score [ Time Frame: 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.

  6. End-tidal carbon dioxide (CO2) [ Time Frame: 4 weeks ]
    End-tidal CO2 at 4 weeks Measured using Freespira breathing system 4 minutes breathing session Parameters number of millimeters per mercury.

  7. Respiratory rate level [ Time Frame: 4 weeks ]
    Respiratory rate at 4 weeks Measured using Freespira breathing system 4 minutes breathing session. The parameters are number of breaths per minute.

  8. Panic Disorder Severity Scale for Adolescents (PDSS-A) [ Time Frame: Visit 1 ]
    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.

  9. Panic Disorder Severity Scale for Adolescents (PDSS-A) [ Time Frame: Week 4 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.

  10. Panic Disorder Severity Scale for Adolescents (PDSS-A) [ Time Frame: Week 8 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.

  11. Panic Disorder Severity Scale for Adolescents (PDSS-A) [ Time Frame: 6-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.

  12. Panic Disorder Severity Scale for Adolescents (PDSS-A) [ Time Frame: 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.

  13. Clinician's Global Impression scale. [ Time Frame: Visit 1 ]

    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.


  14. Clinician's Global Impression scale. [ Time Frame: Week 4 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.


  15. Clinician's Global Impression scale. [ Time Frame: 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.


  16. Child Yale Brown Obsessive-Compulsive Scale score [ Time Frame: Visit 1 ]
    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.

  17. Child Yale Brown Obsessive-Compulsive Scale score [ Time Frame: Week 4 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.

  18. Child Yale Brown Obsessive-Compulsive Scale score [ Time Frame: 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.

  19. Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks) [ Time Frame: Week 8 ]
    Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)


Other Outcome Measures:
  1. Child Sheehan Disability Scale (CSDS) [ Time Frame: Visit 1 ]
    The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).

  2. Child Sheehan Disability Scale (CSDS) [ Time Frame: Week 4 Follow Up ]
    The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).

  3. Child Sheehan Disability Scale (CSDS) [ Time Frame: Week 8 Follow Up ]
    The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).

  4. Children's Depression Inventory ( CDI2) [ Time Frame: Consent Visit ]
    The Children's Depression Inventory (CDI and CDI2) is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. The CDI is a 27-item scale that is self-rated and symptom-oriented. The assessment is now in its second edition. The 27 items on the assessment are grouped into five major factor areas. Clients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.

  5. Children's Depression Inventory ( CDI2) [ Time Frame: Week 4 Follow Up ]
    The Children's Depression Inventory (CDI and CDI2) is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. The CDI is a 27-item scale that is self-rated and symptom-oriented. The assessment is now in its second edition. The 27 items on the assessment are grouped into five major factor areas. Clients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.

  6. Children's Depression Inventory ( CDI2) [ Time Frame: Week 8 Follow Up ]
    The Children's Depression Inventory (CDI and CDI2) is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. The CDI is a 27-item scale that is self-rated and symptom-oriented. The assessment is now in its second edition. The 27 items on the assessment are grouped into five major factor areas. Clients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.

  7. Childhood Anxiety Sensitivity Index (CASI) [ Time Frame: Visit 1 ]
    The Child Anxiety Sensitivity Index is an 18-item scale which measures anxiety sensitivity by asking children to state how aversely they view anxiety symptoms. The child is to mark either "none" (I), "some" (2), or "A Lot" (3) to each item. The child's total anxiety sensitivity score is the sum of his or her points.

  8. Childhood Anxiety Sensitivity Index (CASI) [ Time Frame: Week 4 Follow Up ]
    The Child Anxiety Sensitivity Index is an 18-item scale which measures anxiety sensitivity by asking children to state how aversely they view anxiety symptoms. The child is to mark either "none" (I), "some" (2), or "A Lot" (3) to each item. The child's total anxiety sensitivity score is the sum of his or her points.

  9. Childhood Anxiety Sensitivity Index (CASI) [ Time Frame: Week 8 Follow Up ]
    The Child Anxiety Sensitivity Index is an 18-item scale which measures anxiety sensitivity by asking children to state how aversely they view anxiety symptoms. The child is to mark either "none" (I), "some" (2), or "A Lot" (3) to each item. The child's total anxiety sensitivity score is the sum of his or her points.

  10. Junior Temperament and Character Inventory (JTCI) [ Time Frame: Visit 1 ]
    The Junior Temperament and Character Inventory (JTCI) was developed to assess the temperament ('novelty seeking', 'harm avoidance', 'reward dependence', 'persistence') and character ('self-directedness', 'cooperativeness', 'self-transcendence') dimensions of Cloninger's bio-social model of personality in children and adolescents. Each of the 108 statements can be answered "True" or "False". The parent is to decide which choice best fits the child they are describing in this questionnaire.

  11. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: Visit 1 ]
    The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.

  12. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: Week 4 Follow Up ]
    The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.

  13. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: Week 8 Follow Up ]
    The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.

  14. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: 12 month Follow Up ]
    The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998502


Contacts
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Contact: Marco A Grados, M.D., M.P.H. 443-287-2292 mgrados1@jhmi.edu
Contact: Mary Chen 443-390-8494 mchen117@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
Sponsors and Collaborators
Johns Hopkins University
Palo Alto Health Sciences, Inc.
Investigators
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Principal Investigator: Marco Grados, M.D., M.P.H. Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Informed Consent Form  [PDF] November 1, 2017


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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02998502     History of Changes
Other Study ID Numbers: IRB00097094
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
Obsessive Compulsive Disorder (OCD)
Anxiety
Pediatrics

Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Panic Disorder
Pathologic Processes
Mental Disorders