A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study

Not Applicable

Completed

• Conditions: Vocal Cord Dysfunction

• Registration Number: NCT01916616
• Lead Sponsor: CAMC Health System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-05
• Study Start: 2013-09-01
• Primary Completion: 2015-06-30
• Study Completion: 2015-06-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in frequency and intensity of VCD symptoms	Post intervention at 1 to 3 weeks	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

Name	Time	Method
Change in pulmonary function testing (PFT) measures	Post intervention at 1 to 3 weeks

Trial Locations

Locations (1)

Department of Pediatric, West Virginia University-Charleston Division; 🇺🇸 Charleston, West Virginia, United States