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

NCT03576365 | Completed

• 2 other identifiers: ENT-2017-25834K23DC016335-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Functional Dysphonia; Voice Disorders; Dysphonia

Keywords

Perceived Control; Distress

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (3)

• Voice Handicap

  2 weeks

• Perceived Stress

  2 Weeks

• Psychological Symptoms

  2 weeks

Other Outcomes (2)

• Intervention Module Acceptability

  Baseline and at 2 weeks

• Patients' Adherence to Voice Therapy and Treatment

  2 weeks to 2 years

Study Arms (2)

VOICE Intervention Arm

EXPERIMENTAL

Participants participate in the online VOICE program to learn about perceived control and stress reduction to improve voice outcomes.

Behavioral: VOICE Intervention Arm

Information-Only Arm

SHAM COMPARATOR

Participants participate in the information only program to learn about voice problems, anatomy and physiology.

Behavioral: Information-Only Arm

Interventions

VOICE Intervention Arm BEHAVIORAL

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

VOICE Intervention Arm

Information-Only Arm BEHAVIORAL

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?")

Information-Only Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

University of Minnesota Health Maple Grove Clinic

Maple Grove, Minnesota, 55369, United States

Location

University of Minnesota Health Clinics and Surgeries Otolaryngology Clinic

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (5)

• 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.

  PMID: 15475780 BACKGROUND

• 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.

  PMID: 21299308 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• Derogatis LR. BSI 18 (Brief Symptom Inventory 18): Administration, Scoring, and Procedures Manual. Bloomington, MN: NCS Pearson; 2000

  BACKGROUND

• Nguyen-Feng VN, Frazier PA, Liu Y, Feddema E, Wils B, Nikcevich E, Stockness A, Lim KO, Hu AC, Butcher L, Misono S. Online Intervention for Muscle Tension Dysphonia: A Pilot Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Feb 27;151(4):351-9. doi: 10.1001/jamaoto.2024.5255. Online ahead of print.

  PMID: 40014356 DERIVED

MeSH Terms

Conditions

Voice Disorders; Dysphonia

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephanie Misono, MD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not aware of which treatment arm they are assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: July 3, 2018
• Study Start: April 11, 2016
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)