Voice Therapy Per the Rehabilitation Treatment Specification System

Last updated: February 15, 2026
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Speech Disorders

Treatment

Standard of care voice therapy with non-standard documentation

Standard of care voice therapy with RTSS-Voice documentation

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

Clinical Study ID

NCT06152627
2023P003127
  • Ages > 14
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients diagnosed with pMTD will be excluded if they have secondary diagnosesrelated to structural, neurological, or respiratory disorders such as laryngitis,obvious vocal fold nodules, polyps, cyst, granuloma, sulci, paradoxical vocal foldmotion, chronic cough, confirmed or possible upper airway paralysis/paresis,dysphagia, polypoid corditis, keratosis, presbylarynx, leukoplakia, or history ofradiation to the head/neck. Patients with pMTD will be included regardless ofsubtype (e.g., functional aphonia, vocal fry, ventricular dysphonia) and they canhave secondary diagnoses of reflux.

  • Non-English speakers. The RTSS-Voice's standard and operationalized categories arein English.

Study Design

Total Participants: 600
Treatment Group(s): 4
Primary Treatment: Standard of care voice therapy with non-standard documentation
Phase:
Study Start date:
February 03, 2026
Estimated Completion Date:
June 29, 2027

Study 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.

Connect with a study center

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • New York University

    New York, New York 10017
    United States

    Site Not Available

  • New York University

    New York 5128581, New York 5128638 10017
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Utah

    Salt Lake City 5780993, Utah 5549030 84132
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Active - Recruiting

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