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

NCT ID: NCT01916616

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-01
• Study Completion Date: 2015-06-30

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.

Conditions

Vocal Cord Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Maupin, MD

Role: PRINCIPAL_INVESTIGATOR

WVU Charleston Division

Locations

Department of Pediatric, West Virginia University-Charleston Division

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

1997292

Identifier Type: -

Identifier Source: org_study_id