An interventional study of VOICE Intervention Arm and Information-Only Arm in Functional Dysphonia, Voice Disorders and Dysphonia, sponsored by University of Minnesota. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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.
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.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's planned enrollment of 70 is above the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
Compared within Dysphonia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Voice Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who have clinical need for concurrent treatment will be excluded to decrease confounding introduced by having multiple simultaneous interventions. This may include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants participate in the online VOICE program to learn about perceived control and stress reduction to improve voice outcomes.
Behavioral: VOICE Intervention Arm
Participants participate in the information only program to learn about voice problems, anatomy and physiology.
Behavioral: Information-Only Arm
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
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?")
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.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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.
Time frame: 2 Weeks
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.
Time frame: 2 weeks
Intervention Module Acceptability
Examine the acceptability and usability of the adapted intervention based on feedback from participants via a questionnaire.
Time frame: Baseline and at 2 weeks
Patients' Adherence to Voice Therapy and Treatment
Examine treatment adherence indicators available in the participants' medical charts after intervention is completed (e.g.., did they attend recommended speech therapy sessions, how adherent were they to their speech therapy exercise regimens, how many visits did it take for them to reach treatment goals). This will be assessed through a medical chart review and reported as a percent of sessions attended, percent exercises completed, and number of visits. All measures will be given equal weight and be used together to assess treatment adherence.
Time frame: 2 weeks to 2 years
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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