Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention
Primary Purpose
Functional Dysphonia, Voice Disorders, Dysphonia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VOICE Intervention Arm
Information-Only Arm
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dysphonia focused on measuring Perceived Control, Distress
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
- Prisoner
- Unable to provide informed consent (e.g., patients with dementia)
Sites / Locations
- University of Minnesota Health Maple Grove ClinicRecruiting
- University of Minnesota Health Clinics and Surgeries Otolaryngology ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
VOICE Intervention Arm
Information-Only Arm
Arm Description
Participants participate in the online VOICE program to learn about perceived control and stress reduction to improve voice outcomes.
Participants participate in the information only program to learn about voice problems, anatomy and physiology.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03576365
First Posted
May 10, 2018
Last Updated
July 31, 2023
Sponsor
University of Minnesota
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03576365
Brief Title
Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention
Official Title
Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2016 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dysphonia, Voice Disorders, Dysphonia
Keywords
Perceived Control, Distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are not aware of which treatment arm they are assigned.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VOICE Intervention Arm
Arm Type
Experimental
Arm Description
Participants participate in the online VOICE program to learn about perceived control and stress reduction to improve voice outcomes.
Arm Title
Information-Only Arm
Arm Type
Sham Comparator
Arm Description
Participants participate in the information only program to learn about voice problems, anatomy and physiology.
Intervention Type
Behavioral
Intervention Name(s)
VOICE Intervention Arm
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Information-Only Arm
Intervention Description
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?")
Primary Outcome Measure Information:
Title
Perceived Control
Description
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
Secondary Outcome Measure Information:
Title
Voice Handicap
Description
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
Title
Perceived Stress
Description
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
Title
Psychological Symptoms
Description
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
Other Pre-specified Outcome Measures:
Title
Intervention Module Acceptability
Description
Examine the acceptability and usability of the adapted intervention based on feedback from participants via a questionnaire.
Time Frame
Baseline and at 2 weeks
Title
Patients' Adherence to Voice Therapy and Treatment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Prisoner
Unable to provide informed consent (e.g., patients with dementia)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Stockness, MPH
Phone
6513533018
Ext
33018
Email
nicho656@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Misono, MD, MPH
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Health Maple Grove Clinic
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Stockness, MPH
Phone
651-626-3018
Ext
63018
Email
voice@umn.edu
Facility Name
University of Minnesota Health Clinics and Surgeries Otolaryngology Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Stockness, MPH
Phone
651-626-3018
Ext
63018
Email
voice@umn.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15475780
Citation
Rosen CA, Lee AS, Osborne J, Zullo T, Murry T. Development and validation of the voice handicap index-10. Laryngoscope. 2004 Sep;114(9):1549-56. doi: 10.1097/00005537-200409000-00009.
Results Reference
background
PubMed Identifier
21299308
Citation
Frazier P, Keenan N, Anders S, Perera S, Shallcross S, Hintz S. Perceived past, present, and future control and adjustment to stressful life events. J Pers Soc Psychol. 2011 Apr;100(4):749-765. doi: 10.1037/a0022405. Erratum In: J Pers Soc Psychol. 2011 Apr;100(4):718.
Results Reference
background
PubMed Identifier
6668417
Citation
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Results Reference
background
Citation
Derogatis LR. BSI 18 (Brief Symptom Inventory 18): Administration, Scoring, and Procedures Manual. Bloomington, MN: NCS Pearson; 2000
Results Reference
background
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Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention
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