Voice Therapy Per the Rehabilitation Treatment Specification System

NCT ID: NCT06152627

Last Updated: 2026-02-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-03
• Study Completion Date: 2027-06-29

Brief Summary

The goal of this study is to evaluate if using evidence-based, standard ingredient and target codes from the Rehabilitation Treatment Specification System - Voice Therapy (RTSS-Voice) in standard of care voice therapy documentation can improve outcomes for patients with muscle tension dysphonia (MTD). The main question it aims to answer is: Since the RTSS-Voice will help clinicians think about their treatment more specifically and in relation to nine evidence-based therapies, will its adoption be associated with improved outcomes? Clinicians across five voice centers will be asked to use the RTSS-Voice to document their voice therapy sessions for patients with MTD. Researchers will compare changes in outcomes between two groups of patients: those treated during the clinician's first year using the RTSS-Voice versus those treated during the clinician's second year using the RTSS-Voice.

Detailed Description

The purpose of this study is to evaluate if using evidence-based, standard ingredient and target codes from the Rehabilitation Treatment Specification System - Voice Therapy (RTSS-Voice) in standard of care voice therapy documentation can improve outcomes for patients with muscle tension dysphonia (MTD). RTSS-Voice adoption is likely to be associated with improved outcomes because it requires clinicians to think about their therapy in relation to nine evidence-based therapies (i.e., increased evidence-based practice) and more carefully consider the specific changes in targets directly related to specific clinical actions, i.e., improved clinical reasoning. Sixty patents will be enrolled per year (at minimum) from each of the five participating voice centers, i.e., 300 patients in Years 1 and 2 (total patients = 600). For each patient, outcomes will be collected before and after therapy including patient-reported vocal functioning, clinician-reported voice quality, an objective measure associated with overall voice quality (Cepstral Peak Prominence/CPP), and total number of sessions. Each voice center uses different patient-reported and clinician-reported measures. Thus, linear regression models will examine changes in outcomes during Year 1 versus Year 2 for each individual site. The different patient- and clinician-reported measures have been found to be highly correlated. Therefore, individual sites will also be pooled together in a mini meta-analysis. Standardized effect sizes (Cohen's d) will be calculated for each site, representing the effect of RTSS-Voice adoption. Using a fixed effects model, an average effect size across sites will be calculated, weighted by sample size. The average effect size across sites will then represent the overall effect of the implementation on vocal functioning, voice quality, CPP, and number of sessions. Power: The investigators anticipate a minimum of 60 patients per site, (total of 300 patients per year). For site-specific analyses, a sample size of 60 patients for each group (Year 1 versus Year 2) is associated with 80% power to detect the smallest clinically meaningful effect size: d = .5. The effect size d = .5 was chosen because it is the smallest effect that is "visible to the naked eye" associated with rejecting the null hypothesis and supporting the alternative hypothesis in rehabilitation treatment studies and used in multiple voice studies.

Conditions

Muscle Tension Dysphonia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

First Year of RTSS-Voice use

These 300 patients from five Voice Centers will receive standard of care voice therapy where their treating clinicians will be trained to use the RTSS-Voice in their documentation.

Standard of care voice therapy with novice clinician RTSS-Voice documentation

Intervention Type: BEHAVIORAL

Voice therapy is individually tailored to each patient and typically includes behavioral ingredients (e.g., applying pressure to the anterior neck, practice voicing in various ways, feedback on performance, provide information on the importance of therapy concepts) to modify the patient's auditory, somatosensory, vocal, musculoskeletal, respiratory, and mental functions. During this time, the treating clinicians will be trained to use the RTSS-Voice in their clinical documentation.

Second Year of RTSS-Voice use

These 300 patients from five Voice Centers will receive standard of care voice therapy where their treating clinicians have already been trained to use the RTSS-Voice in their documentation.

Standard of care voice therapy with expert clinician RTSS-Voice documentation

Intervention Type: BEHAVIORAL

Voice therapy is individually tailored to each patient and typically includes behavioral ingredients (e.g., applying pressure to the anterior neck, practice voicing in various ways, feedback on performance, provide information on the importance of therapy concepts) to modify the patient's auditory, somatosensory, vocal, musculoskeletal, respiratory, and mental functions. During this time, the treating clinicians will have completed their RTSS-Voice training and using the RTSS-Voice in their clinical documentation.

Interventions

Standard of care voice therapy with novice clinician RTSS-Voice documentation

Voice therapy is individually tailored to each patient and typically includes behavioral ingredients (e.g., applying pressure to the anterior neck, practice voicing in various ways, feedback on performance, provide information on the importance of therapy concepts) to modify the patient's auditory, somatosensory, vocal, musculoskeletal, respiratory, and mental functions. During this time, the treating clinicians will be trained to use the RTSS-Voice in their clinical documentation.

Intervention Type: BEHAVIORAL

Standard of care voice therapy with expert clinician RTSS-Voice documentation

Voice therapy is individually tailored to each patient and typically includes behavioral ingredients (e.g., applying pressure to the anterior neck, practice voicing in various ways, feedback on performance, provide information on the importance of therapy concepts) to modify the patient's auditory, somatosensory, vocal, musculoskeletal, respiratory, and mental functions. During this time, the treating clinicians will have completed their RTSS-Voice training and using the RTSS-Voice in their clinical documentation.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of primary Muscle Tension Dysphonia (pMTD)
• Patients with pMTD will be included regardless of subtype (e.g., functional aphonia, vocal fry, ventricular dysphonia) and they can have secondary diagnoses of reflux.

Exclusion Criteria

• Patients diagnosed with pMTD will be excluded if they have secondary diagnoses related to structural, neurological, or respiratory disorders such as laryngitis, obvious vocal fold nodules, polyps, cyst, granuloma, sulci, paradoxical vocal fold motion, chronic cough, confirmed or possible upper airway paralysis/paresis, dysphagia, polypoid corditis, keratosis, presbylarynx, leukoplakia, or history of radiation to the head/neck. Patients with pMTD will be included regardless of subtype (e.g., functional aphonia, vocal fry, ventricular dysphonia) and they can have secondary diagnoses of reflux.
• Non-English speakers. The RTSS-Voice's standard and operationalized categories are in English.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jarrad Van Stan

Associate Professor of Surgery and Speech-Language Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jarrad Van Stan, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Emory University

Atlanta, Georgia, United States

Site Status: RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

New York University

New York, New York, United States

Site Status: RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

University of Wisconsin

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jarrad Van Stan, PhD, CCC-SLP

Role: CONTACT

jvanstan@mgh.harvard.edu

617-643-8410

Facility Contacts

Amanda Gillespie, PhD, CCC-SLP

Role: primary

amanda.i.gillespie@emory.edu

404-778-3381

Jarrad Van Stan, PhD, CCC-SLP

Role: primary

jvanstan@mgh.harvard.edu

617-643-8410

Jeremy Wolfberg, MS, CCC-SLP

Role: backup

jwolfberg@mgb.org

Aaron Johnson, PhD, CCC-SLP

Role: primary

Aaron.Johnson@nyulangone.org

646-754-1207

Julie Barkmeier-Kreamer, PhD, CCC-SLP

Role: primary

JulieB.Kraemer@hsc.utah.edu

801-585-7143

Susan Thibeault, PhD, CCC-SLP

Role: primary

thibeault@surgery.wisc.edu

608-263-6751

Other Identifiers

2023P003127

Identifier Type: -

Identifier Source: org_study_id