NCT03576365

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Dysphonia
• Voice Disorders
• Dysphonia

Interventions

Type	Name	Description
BEHAVIORAL	VOICE 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
BEHAVIORAL	Information-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?")

Timeline

• Start date: 2016-04-11
• Primary completion: 2025-01-14
• Completion: 2025-01-14
• First posted: 2018-07-03
• Last updated: 2025-02-10

Locations

2 sites across 1 country: United States