Back to resultsA Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study
Primary Purpose
Vocal Cord Dysfunction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques
Sponsored by
About this trial
This is an interventional treatment trial for Vocal Cord Dysfunction focused on measuring paradoxical vocal fold motion, cognitive-behavioral therapy
Eligibility Criteria
Inclusion Criteria:
- Adolescent patients presenting to West Virginia University, Charleston Division Sub-specialty Clinic for Pediatric Pulmonology with a clinical diagnosis of vocal cord dysfunction.
- Diagnosed with VCD within 12 months prior to study enrollment. between the ages of 13 and 18 years old.
- Currently symptomatic for VCD.
- Must have a baseline PFT to reference at the time of diagnosis. Additionally in patients who were diagnosed with VCD 6 months or more prior to study enrollment, current PFT results as part of routine care, are required.
- A parent or guardian must agree to participate in the four behavioral therapy sessions with his or her child.
Exclusion Criteria:
- Severe psychiatric disorders (ex. psychosis, suicidal ideation)
- Developmental delay
- Previous speech therapy for the treatment of VCD.
- Currently receiving psychological counseling.
- In open Child Protective Services cases.
Sites / Locations
- Department of Pediatric, West Virginia University-Charleston Division
Outcomes
Primary Outcome Measures
Change in frequency and intensity of VCD symptoms
Self-reported number of symptomatic episodes and mean intensity of episodes pre and post-CBT intervention will be compared. Symptom intensity will be measured using an 11 point Likert Scale for self-reported distress for each recorded VCD episode.
Secondary Outcome Measures
Change in pulmonary function testing (PFT) measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01916616
Brief Title
A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study
Official Title
A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2013 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
June 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CAMC Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vocal Cord Dysfunction (VCD) is characterized by involuntary closure of the vocal cords while inhaling. Children and adolescents with VCD may experience multiple symptoms, including difficulty breathing, coughing, wheezing, neck tightness, and voice changes. There is limited information on optimal management of VCD. In our proposed study, we will use cognitive-behavioral therapy (CBT) techniques to change how patients respond to their VCD symptoms. Measurements of airflow during breathing as well as symptom frequency and intensity will be examined prior to and following a series of four therapy sessions with a clinical psychologist that are focused on teaching patients strategies to decrease symptom reactivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord Dysfunction
Keywords
paradoxical vocal fold motion, cognitive-behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques
Intervention Description
At the four therapy sessions, subjects will work with the psychologist to identify the triggers of their VCD episodes, learn to self-monitor symptoms and reactions, and be taught breathing retraining/relaxation techniques. The goal is to decrease patterns of subjects' thinking or behaviors that exacerbate distress from VCD symptoms.
Primary Outcome Measure Information:
Title
Change in frequency and intensity of VCD symptoms
Description
Self-reported number of symptomatic episodes and mean intensity of episodes pre and post-CBT intervention will be compared. Symptom intensity will be measured using an 11 point Likert Scale for self-reported distress for each recorded VCD episode.
Time Frame
Post intervention at 1 to 3 weeks
Secondary Outcome Measure Information:
Title
Change in pulmonary function testing (PFT) measures
Time Frame
Post intervention at 1 to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adolescent patients presenting to West Virginia University, Charleston Division Sub-specialty Clinic for Pediatric Pulmonology with a clinical diagnosis of vocal cord dysfunction.
Diagnosed with VCD within 12 months prior to study enrollment. between the ages of 13 and 18 years old.
Currently symptomatic for VCD.
Must have a baseline PFT to reference at the time of diagnosis. Additionally in patients who were diagnosed with VCD 6 months or more prior to study enrollment, current PFT results as part of routine care, are required.
A parent or guardian must agree to participate in the four behavioral therapy sessions with his or her child.
Exclusion Criteria:
Severe psychiatric disorders (ex. psychosis, suicidal ideation)
Developmental delay
Previous speech therapy for the treatment of VCD.
Currently receiving psychological counseling.
In open Child Protective Services cases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Maupin, MD
Organizational Affiliation
WVU Charleston Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric, West Virginia University-Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study
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