Dysphonia, Functional Dysphonia, Voice Disorders
Conditions
Keywords
Perceived Control, Distress
Brief 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. 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.
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.
Interventions
BEHAVIORALVOICE Intervention 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
BEHAVIORALInformation-Only Arm
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?)
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are not aware of which treatment arm they are assigned.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Patients between 18-80 years of age experiencing a voice problem 3. Scored high (\>10) on the Voice Handicap Index (VHI-10) 4. Has the ability to complete informed consent process 5. Interested in using an online program/intervention 6. Has reliable access to internet
Exclusion criteria
1. Patients who have clinical need for concurrent treatment will be excluded to decrease confounding introduced by having multiple simultaneous interventions. This may include: 1. Concurrent laryngeal lesion requiring immediate operative or other intervention 2. Concurrent participation in speech therapy 3. Concurrent need for new medications that may directly affect voice-related symptoms 2. Participant has a Speech Language Pathology visit scheduled in two weeks or less from when they will start the program (if applicable) 3. Unable to read English (as determined by their ability to complete the clinic intake forms) 4. Female and pregnant 5. Prisoner 6. Unable to provide informed consent (e.g., patients with dementia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Control | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voice Handicap | 2 weeks | 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. |
| Perceived Stress | 2 Weeks | 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. |
| Psychological Symptoms | 2 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intervention Module Acceptability | Baseline and at 2 weeks | Examine the acceptability and usability of the adapted intervention based on feedback from participants via a questionnaire. |
| Patients' Adherence to Voice Therapy and Treatment | 2 weeks to 2 years | 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. |
Countries
United States
Outcome results
None listed