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Clinical Trials/NCT03576365
NCT03576365
Completed
Not Applicable

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

University of Minnesota2 sites in 1 country70 target enrollmentApril 11, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Functional Dysphonia
Sponsor
University of Minnesota
Enrollment
70
Locations
2
Primary Endpoint
Perceived Control
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 11, 2016
End Date
January 14, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

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:
  • 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)
  • Female and pregnant
  • Unable to provide informed consent (e.g., patients with dementia)

Outcomes

Primary Outcomes

Perceived Control

Time Frame: 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 Outcomes

  • Voice Handicap(2 weeks)
  • Perceived Stress(2 Weeks)
  • Psychological Symptoms(2 weeks)

Study Sites (2)

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