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

NCT01916616 | Completed

• 1 other identifier: 1997292
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

paradoxical vocal fold motion; cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in pulmonary function testing (PFT) measures

  Post intervention at 1 to 3 weeks

Interventions

Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques BEHAVIORAL

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.

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Department of Pediatric, West Virginia University-Charleston Division

Charleston, West Virginia, 25302, United States

Location

MeSH Terms

Conditions

Vocal Cord Dysfunction

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Kevin Maupin, MD

  WVU Charleston Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 5, 2013
• Study Start: September 1, 2013
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

US (1)