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OpenTrials
Completed

NCT Number: NCT01916616

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

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric, West Virginia University-Charleston Division

Charleston, West Virginia, 25302, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Change in pulmonary function testing (PFT) measures

    Time frame: Post intervention at 1 to 3 weeks

Sponsors and collaborators

Lead sponsor

CAMC Health System

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2013
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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