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

NCT03576365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-02-10

No results posted yet for this study

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.

Conditions

  • Functional Dysphonia
  • Voice Disorders
  • Dysphonia

Interventions

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?")

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH
  • University of Minnesota

    lead OTHER

Principal Investigators

  • Stephanie Misono, MD, MPH · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-11
Primary Completion
2025-01-14
Completion
2025-01-14

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576365 on ClinicalTrials.gov