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

Vocal Cord Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916616
• Other study ID #: 1997292
• Status: Completed
• Phase: N/A
• Start date: September 1, 2013
• Est. completion date: June 30, 2015

Study information

• Verified date: March 2020
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vocal Cord Dysfunction

Intervention

Behavioral:
• Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques
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.

Locations

Country	Name	City	State
United States	Department of Pediatric, West Virginia University-Charleston Division	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post intervention at 1 to 3 weeks
Secondary	Change in pulmonary function testing (PFT) measures		Post intervention at 1 to 3 weeks