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

Not Applicable

Recruiting

• Conditions: Voice Disorders; Dysphonia; Functional Dysphonia
• Interventions: Behavioral: Information-Only Arm; Behavioral: VOICE Intervention Arm

• Registration Number: NCT03576365
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2016-04-11
• Study First Submitted: 2018-05-10
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-07-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Information-Only Arm	Information-Only Arm	Participants participate in the information only program to learn about voice problems, anatomy and physiology.
VOICE Intervention Arm	VOICE Intervention Arm	Participants participate in the online VOICE program to learn about perceived control and stress reduction to improve voice outcomes.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

University of Minnesota Health Maple Grove Clinic; 🇺🇸 Maple Grove, Minnesota, United States

University of Minnesota Health Clinics and Surgeries Otolaryngology Clinic; 🇺🇸 Minneapolis, Minnesota, United States