Intensive Versus Traditional Voice Therapy

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03129880
• Collaborator: (none)
• Enrollment: 73
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 83.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphonia	Behavioral: Weekly Voice Therapy; Behavioral: Intensive Voice Therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: For purposes of this study participants will be randomized into one of the following two groups: 4-6 weekly standard of care therapy sessions, once a week, for a maximum of six weeks 4-6 standard of care therapy sessions in one day Standard of care treatment may continue past patient enrollment in this study.For purposes of this study participants will be randomized into one of the following two groups:4-6 weekly standard of care therapy sessions, once a week, for a maximum of six weeks 4-6 standard of care therapy sessions in one day Standard of care treatment may continue past patient enrollment in this study.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Voice-related Outcomes in Response to Intensive Versus Traditional Therapy Programs
• Actual Study Start Date: Mar 13, 2016
• Anticipated Primary Completion Date: Mar 12, 2023
• Anticipated Study Completion Date: Mar 12, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Self-efficacy and readiness scale Changes [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)

2. Self-efficacy and readiness scale Change [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin-Madison Voice and Swallow Clinic	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT03129880
• Other Study ID Numbers: 2015-0763; A539772; SMPH/SURGERY/SPEECH; Protocol Version 12/2/2020
• First Posted: Apr 26, 2017
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Wisconsin, Madison: Voice disorder; Hoarseness; Phonation Disorders; Speech Disorders
• Additional relevant MeSH terms: Dysphonia

Study Results

No Results Posted as of Feb 8, 2022