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Functional DysphoniaNCT03576365

Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention

A study testing VOICE Intervention Arm and Information-Only Arm in people with Functional Dysphonia and Voice Disorders, run by University of Minnesota at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to pilot test a version of the intervention that has been tailored for participants with dysphonia. The study seeks to determine if the adapted intervention: a) increases perceived control over voice-related stressors and b) decreases stress and distress resulting from voice problems. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Functional Dysphonia, Voice Disorders, Dysphonia
What is being tested?
VOICE Intervention Arm and Information-Only Arm
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
2 sitesUnited States
Study dates
11 Apr 2016to 14 Jan 2025
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are seen at the Otolaryngology Clinic (University of Minnesota Health Clinics and Surgery Center, or Fairview Hospital Maple Grove or Southdale) with Muscle Tension Dysphonia
  • Patients between 18-80 years of age experiencing a voice problem
  • Scored high (>10) on the Voice Handicap Index (VHI-10)
  • Has the ability to complete informed consent process
  • Interested in using an online program/intervention
  • Has reliable access to internet

Who cannot join

  • Patients who have clinical need for concurrent treatment will be excluded to decrease confounding introduced by having multiple simultaneous interventions. This may include:
  • Concurrent laryngeal lesion requiring immediate operative or other intervention
  • Concurrent participation in speech therapy
  • Concurrent need for new medications that may directly affect voice-related symptoms
  • Participant has a Speech Language Pathology visit scheduled in two weeks or less from when they will start the program (if applicable)
  • Unable to read English (as determined by their ability to complete the clinic intake forms)
Show all 9Show fewer
  • Female and pregnant
  • Prisoner
  • Unable to provide informed consent (e.g., patients with dementia)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Minnesota Health Maple Grove Clinic

    Maple Grove, Minnesota, 55369

  • University of Minnesota Health Clinics and Surgeries Otolaryngology Clinic

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

The purpose of this study is to pilot test a version of the intervention that has been tailored for participants with dysphonia. The study seeks to determine if the adapted intervention: a) increases perceived control over voice-related stressors and b) decreases stress and distress resulting from voice problems. The study will also explore the usability and acceptability of the program. The goal is to help people with voice problems achieve better voice and quality of life outcomes.

Read the detailed description

In the investigator's voice clinic, a high prevalence of severe distress has been identified. Distress and voice handicap were positively correlated, and perceived control moderated the relationship. Perceived control is associated with less distress in a variety of medical conditions, has an impact beyond that of coping and personality, and can be increased via targeted intervention.

This is a randomized controlled trial. Participants will be randomly assigned to one of the two groups. Both groups involve completing surveys and receiving information online about voice problem.

Participants complete an initial baseline assessment focused on voice function and emotions, including items from the Perceived Control Scale, Voice Handicap Index-10, Perceived Stress Scale, Brief Symptom Inventory-18. Finally, the participants will complete some brief feedback questions about the material.

Next, twice a week for up to three weeks participants will complete check-ins from the online program. Participants in the intervention arm will complete self-guided exercises and brief assessment questions. Participants in the information-only arm will complete mini knowledge quizzes.

All participants will complete brief a post-intervention assessment parallel to the baseline assessment. Lastly, they will have an opportunity to provide final feedback on their experience.

Follow-up with each participant will occur one and three months after finishing the program. Questionnaires will be sent via email including Voice Handicap Index-10, Present Perceived Control-8, and questions regarding treatment adherence and voice outcomes.

Being tested
VOICE Intervention Arm, Information-Only Arm
Keywords
Perceived Control, Distress
Medical subject headings
Voice Disorders, Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VOICE Intervention ArmBehavioural

    Introductory and background information about voice problems and psychosocial distress

    • Examples of concerns raised by patients with voice problems (e.g., "I feel left out of conversations because of my voice problem")
    • Information about perceived control and how improving perceived control can lead to decreased distress
    • Examples of strategies that have helped patients identify controllable and uncontrollable aspects of their voice problems (e.g., "I learned to plan to take breaks to rest my voice between teaching classes")
    • Self-guided exercises designed to help improve perceived control and develop better management skills for voice problem symptoms

  • Information-Only ArmBehavioural

    General introduction of the program and background on voice related information in an interactive manner

    • Examples of what patients want to learn more about the voice (e.g., "I would like to learn more about how the voice works when it is healthy")
    • Information on the anatomy of the voice and how the voice works
    • Educational materials to help understand voice physiology and function
    • Self-guided learning exercises (e.g., "what are some things about vocal function that you would like to learn more about?")
Study groups in NCT03576365
Study groupRoleWhat they receive
VOICE Intervention ArmExperimentalParticipants participate in the online VOICE program to learn about perceived control and stress reduction to improve voice outcomes.
Receives: Behavioral: VOICE Intervention Arm
Information-Only ArmSham comparatorParticipants participate in the information only program to learn about voice problems, anatomy and physiology.
Receives: Behavioral: Information-Only Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Control

    Change from baseline assessment using a questionnaire, Perceived Present Control-8 (PPC-8).

    The PPC-8 questionnaire has 8 questions about perceptions of present control over their voice problem, assessed on a 4-point Likert-type scale, with scores of 1-4 (1=Strongly Disagree, 2=Disagree Somewhat, 3=Agree Somewhat, 4=Strongly Agree). Total scores range from 1-32. Higher scores indicate more perceived control over the patient's voice problems.

    Measured: 2 weeks

Secondary outcomes (3)

  1. Voice Handicap

    Change from baseline assessment using a questionnaire, Voice Handicap Index-10 (VHI-10).

    The VHI-10 questionnaire has 10 questions about voice problems and the effect it has on the patients life, assessed on a 4-point Likert-type scale, with scores of 0-4 (0=Never, 1=Almost Never, 2=Sometimes, 3=Almost Always, 4=Always). Total scores range from 0-40. Higher scores indicate a more problematic voice. The clinical cutoff for a problematic voice is a VHI-10 score of 10, where scores >10 indicate voice problems. A change of at least 6 points is clinically significant.

    Measured: 2 weeks

  2. Perceived Stress

    Change from baseline assessment using a questionnaire, Perceived Stress Scale-4 (PSS-4).

    The PSS-4 questionnaire has 4 questions about perceived stress, assessed on a 5-point Likert-type scale, with scores of 0-4 (0=Never, 1=Almost Never, 2=Sometimes, 3=Fairly Often, 4=Very Often). Total scores range from 0-16. Higher scores indicate more perceived stress in the patient's life.

    Measured: 2 Weeks

  3. Psychological Symptoms

    Change from baseline assessment using a questionnaire, Brief Symptom Inventory-18 (BSI-18).

    The BSI-18 questionnaire has 18 questions about psychological symptoms, assessed on a 5-point Likert-type scale, with scores of 0-4 (0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely). Total scores range from 0-72. Higher scores indicate more extreme psychological symptoms. Patients with "High Risk" psychological symptoms have a score of 57 (75 percentile) or greater.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2018
  2. Study start11 Apr 2016
  3. Primary completion14 Jan 2025
  4. Study completion14 Jan 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03576365
Sponsor's protocol ID
ENT-2017-25834
Other IDs
K23DC016335-01
Status last verified
Feb 2025
First submitted
10 May 2018
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rosen CA, Lee AS, Osborne J, Zullo T, Murry T. Development and validation of the voice handicap index-10. Laryngoscope. 2004 Sep;114(9):1549-56. doi: 10.1097/00005537-200409000-00009.

    PubMed 15475780

  • Frazier P, Keenan N, Anders S, Perera S, Shallcross S, Hintz S. Perceived past, present, and future control and adjustment to stressful life events. J Pers Soc Psychol. 2011 Apr;100(4):749-765. doi: 10.1037/a0022405.

    PubMed 21299308

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PubMed 6668417

  • Derogatis LR. BSI 18 (Brief Symptom Inventory 18): Administration, Scoring, and Procedures Manual. Bloomington, MN: NCS Pearson; 2000

  • Nguyen-Feng VN, Frazier PA, Liu Y, Feddema E, Wils B, Nikcevich E, Stockness A, Lim KO, Hu AC, Butcher L, Misono S. Online Intervention for Muscle Tension Dysphonia: A Pilot Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Feb 27;151(4):351-9. doi: 10.1001/jamaoto.2024.5255. Online ahead of print.

    PubMed 40014356

Questions about this trial

What is this clinical trial studying?

A study testing VOICE Intervention Arm and Information-Only Arm in people with Functional Dysphonia and Voice Disorders, run by University of Minnesota at 2 sites 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 6 inclusion and 9 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Perceived Control (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03576365, which also lists 5 linked publications.

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 10 Feb 2025.

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