Intensive Versus Traditional Voice Therapy

May 15, 2024 updated by: University of Wisconsin, Madison

Voice-related Outcomes in Response to Intensive Versus Traditional Therapy Programs

The purpose of this study is to determine if there are differences in treatment outcomes between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive voice therapy, consisting of 4-6 therapy sessions performed within one day.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of voice therapy is optimal long-term vocal quality and communication function with minimal recurrence. Traditional voice therapy for dysphonia typically consists of one to two therapy sessions each week with a single clinician for about 8 weeks. Another approach of voice therapy is intensive short-term therapy also known as "boot camp." This approach, borrows from the disciplines of neurobiology, exercise physiology, motor learning, and psychotherapy which describe desirable learning and behavior changes influenced by practice that involves high-intensity overload, variability, and specificity of training. A few studies have showed that "Boot Camp" model of intensive therapy resulted in comparable gains in voice quality and vibratory mechanics and may promote better patient satisfaction and attendance.

While such findings support the notion that intensive voice therapy may enhance voice therapy outcomes, no study to date has examined patient response to the "Boot Camp" approach to voice therapy. The investigators will compare the outcomes of traditional, weekly voice therapy and intensive voice therapy with multiple sessions in one day.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison Voice and Swallow Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with a Voice disorder
  • Diagnosed with benign vocal fold lesions and/or hyper-function
  • First/primary propose treatment modality is voice therapy
  • Patients who are appropriate for either standard of care treatment modality (traditional or intensive voice therapy)
  • Willingness to participate in either standard of care treatment modality
  • All races
  • Males and females
  • English speaking

Exclusion Criteria:

  • Younger than 18
  • Inability or unwillingness to participate in one of the standard of care treatment modalities
  • Laryngeal Surgery or procedures during course of study
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Weekly Voice Therapy
Participants are randomized to receiving weekly voice therapy sessions
Behavioral: Weekly Voice Therapy
Participants will be randomized to receive weekly voice therapy
Active Comparator: Intensive Voice Therapy
Participants are randomized to receiving multiple sessions of voice therapy in one day
Behavioral: Intensive Voice Therapy
Participants will be randomized to receive multiple sessions of voice therapy in one day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy and readiness scale Changes
Time Frame: Baseline compared to Immediately post voice therapy
Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
Baseline compared to Immediately post voice therapy
Self-efficacy and readiness scale Change
Time Frame: Baseline compared to 12 weeks post voice therapy
Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
Baseline compared to 12 weeks post voice therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Emerald J Doll, MS, CCC-SLP, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2016

Primary Completion (Actual)

March 12, 2024

Study Completion (Actual)

March 12, 2024

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0763
  • A539772 (Other Identifier: UW Madison)
  • SMPH/SURGERY/SPEECH (Other Identifier: UW Madison)
  • Protocol Version 12/2/2020 (Other Identifier: Minimal Risk IRB (Health Sciences), UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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