Vocal Cord DysfunctionNCT01916616
A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study
A study testing Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques and Cognitive Behavioral Therapy (CBT) in people with Vocal Cord Dysfunction, run by CAMC Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Vocal Cord Dysfunction
- What is being tested?
- Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2013to 30 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Pediatric, West Virginia University-Charleston Division
Charleston, West Virginia, 25302
About this 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.
- Conditions
- Vocal Cord Dysfunction
- Being tested
- Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques, Cognitive Behavioral Therapy (CBT)
- Keywords
- paradoxical vocal fold motion, cognitive-behavioral therapy
- Medical subject headings
- Vocal Cord Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniquesBehavioural
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.
Cognitive Behavioral Therapy (CBT)Behavioural
Four-session cognitive behavioral therapy program designed to reduce symptom reactivity and improve management of vocal cord dysfunction symptoms through psychoeducation, breathing retraining, cognitive restructuring, homework exercises, and caregiver involvement.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Adolescents with vocal cord dysfunction received four structured cognitive behavioral therapy sessions delivered by a clinical psychologist over approximately 4 to 12 weeks. Therapy included psychoeducation, symptom monitoring, diaphragmatic breathing retraining, cognitive restructuring, coping-skills development, and relapse prevention planning. Participants underwent assessment of systems and pulmonary function before and after completion of intervention. Receives: Behavioral: Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques; Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post intervention at 1 to 3 weeks
Secondary outcomes (1)
Change in pulmonary function testing (PFT) measures
Measured: Post intervention at 1 to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start1 Sep 2013
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Maupin, MD, Principal investigator, WVU Charleston Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916616
- Sponsor's protocol ID
- 1997292
- Status last verified
- Mar 2020
- First submitted
- 1 Aug 2013
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study
- ClinicalTrials.gov ID
- NCT01916616
- Acronym / sponsor ID
- 1997292
- Conditions
- Vocal Cord Dysfunction
- Keywords
- paradoxical vocal fold motion, cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques, Behavioral: Cognitive Behavioral Therapy (CBT)Adolescents with vocal cord dysfunction received four structured cognitive behavioral therapy sessions delivered by a clinical psychologist over approximately 4 to 12 weeks. Therapy included psychoeducation, symptom monitoring, diaphragmatic breathing retraining, cognitive restructuring, coping-skills development, and relapse prevention planning. Participants underwent assessment of systems and pulmonary function before and after completion of intervention. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniquesAt 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. | Behavioural | Cognitive Behavioral Therapy (CBT) |
| Cognitive Behavioral Therapy (CBT)Four-session cognitive behavioral therapy program designed to reduce symptom reactivity and improve management of vocal cord dysfunction symptoms through psychoeducation, breathing retraining, cognitive restructuring, homework exercises, and caregiver involvement. | Behavioural | Cognitive Behavioral Therapy (CBT) |
Primary outcome
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.
1 secondary outcome
Change in pulmonary function testing (PFT) measures
Time frame: Post intervention at 1 to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Maupin, MD principal investigator
WVU Charleston Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques and Cognitive Behavioral Therapy (CBT) in people with Vocal Cord Dysfunction, run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency and intensity of VCD symptoms (time frame: Post intervention at 1 to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.