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Clinical Trials/NCT01916616
NCT01916616
Completed
Not Applicable

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

CAMC Health System1 site in 1 country20 target enrollmentSeptember 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vocal Cord Dysfunction
Sponsor
CAMC Health System
Enrollment
20
Locations
1
Primary Endpoint
Change in frequency and intensity of VCD symptoms
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2013
End Date
June 30, 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
CAMC Health System
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in frequency and intensity of VCD symptoms

Time Frame: 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 Outcomes

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

Study Sites (1)

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