Voice Therapy via Telepractice & App for Voice Disorders

Overseen By Elizabeth U Grillo, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Chester University of Pennsylvania

Disqualifiers: Not a teacher, No smartphone

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

Due to the COVID-19 pandemic, telepractice has grown rapidly. To date, synchronous telepractice (i.e., in real-time videoconferencing) has been the focus of most research with asynchronous telepractice (i.e. information stored and accessed later) being used minimally only to record synchronous encounters. Descriptions of voice therapy concepts are minimally available in the literature with no standard reporting framework and no clinical efficacy or effectiveness data. Thus, the proposed study will address these barriers. First, an asynchronous method will be developed that will impact both in-person and telepractice services by offering repeated learning opportunities in the client's environment. The method includes ecological momentary intervention (EMI) through a daily voice therapy practice app, server, and web portal that is flexible in its programming to meet the needs of the client, offers performance feedback, and charts results over time. Second, voice therapy concepts will be tested improving our knowledge about such concepts that facilitate successful client-centered outcomes for both prevention and treatment of voice problems. The participants in the study will be teachers who have a high prevalence of voice problems, impact the healthcare system when treatment is needed, and negatively affect students' learning abilities in the classroom when communicating with a voice problem. Third, the Rehabilitation Treatment Specification System (RTSS) framework will be used to describe the voice therapy concepts. The concepts include: training multiple voices to meet all the clients' vocal needs, defining voice qualities by the anatomy and physiology of the voice production system, generalizing voice targets into hierarchical speech tasks, and using "new" vs "other/old" voice to help the client become their own clinician. Vocally healthy student teachers and professional teachers with voice complaints will be randomized into one of four voice therapy conditions delivered via telepractice. Both groups of teachers are needed to assess the concepts for prevention and treatment. Condition 2, which fully represents the proposed voice therapy concepts, will be superior to the other three conditions, which do not fully represent the concepts, by demonstrating a greater decrease in client-reported primary outcome measures of the Voice Handicap Index-10 and factor 1 and 2 of the Vocal Fatigue Index. Secondary outcomes of acoustic measures, Borg Category Ratio-10 scales for vocal and mental effort, and voice therapy satisfaction surveys will also be investigated. The results will be useful at a practical level by advancing asynchronous telepractice and by improving efficacy of voice therapy concepts. In addition, the results will lay the groundwork for future studies involving development of EMI platforms in other areas of speech-language pathology and testing additional voice therapy concepts that facilitate successful client-centered outcomes.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Voice Therapy via Telepractice & App for Voice Disorders?

Research shows that the Global Voice Therapy Model (GVTM) improved voice measures in adults with voice disorders, suggesting that similar voice therapy approaches can be effective. Additionally, Conversation Training Therapy (CTT) focuses on voice awareness and efficient production, which may contribute to its effectiveness in treating voice disorders. ^{1 2 3 4 5}

Is voice therapy via telepractice and app safe for humans?

The studies reviewed do not report any safety concerns for voice therapy methods like the Global Voice Therapy Model or Conversation Training Therapy, suggesting they are generally safe for human use. ^{1 4 6 7 8}

How is the Voice Therapy via Telepractice & App for Voice Disorders treatment different from other treatments for voice disorders?

This treatment is unique because it uses telepractice and app-based methods to deliver voice therapy, focusing on real-time conversation training without a traditional hierarchy. It emphasizes voice awareness and efficient production in natural conversations, making it more flexible and accessible compared to traditional in-person therapies. ^{4 9 10 11 12}

Research Team

Elizabeth U Grillo, Ph.D.

Principal Investigator

West Chester University

Eligibility Criteria

This trial is for student teachers planning to teach in the spring and professional teachers currently working with voice complaints. Participants must own an Android or iOS smartphone or tablet but haven't sought help for their voice issues.

Inclusion Criteria

Owner of either an android or iOS smartphone or tablet.

I am a working teacher with voice issues but haven't sought help.

I am a healthy education student planning to teach this spring.

Exclusion Criteria

This criterion means that people who are not professional teachers are eligible for the study.

Not a student teacher

Does not own a smartphone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo voice therapy through telepractice, utilizing both synchronous and asynchronous methods, including ecological momentary intervention via a daily voice therapy practice app.

15 weeks

Weekly sessions via telepractice

Follow-up

Participants are monitored for changes in voice quality and therapy satisfaction after treatment.

4 weeks

Treatment Details

Interventions

• Conversation Training Therapy
• Global Voice Prevention and Therapy Model
• Modified Conversation Training Therapy
• Modified Global Voice Prevention and Therapy Model

Trial Overview The study tests four different voice therapy methods delivered via telepractice, focusing on preventing and treating voice disorders in teachers. It uses a daily practice app for feedback and tracks progress over time.

Participant Groups

Group I: Modified Global Voice Prevention and Therapy Model Experimental Treatment 1 Intervention

Group II: Modified Conversation Training Therapy Experimental Treatment 1 Intervention

Group III: Global Voice Prevention and Therapy Model Experimental Treatment 1 Intervention

Group IV: Conversation Training Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

West Chester University of Pennsylvania

Lead Sponsor

Trials

6

Recruited

1,300+

Findings from Research

The Global Voice Therapy Model (GVTM) was effective in improving voice quality, as evidenced by significant changes in acoustic, aerodynamic, and perceptual voice measures in four adults with voice disorders.

Participants showed measurable improvements in their voice measures after therapy, indicating that GVTM can be a beneficial approach for individuals seeking voice therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical investigation of the Global Voice Therapy Model. Grillo, EU.[2022]

Patients receiving individual short-term intensive voice therapy (IVT-I) and long-term traditional voice therapy (TVT) reported similar satisfaction and perceived progress in their vocal quality, indicating that both approaches can be effective.

However, patients in the IVT-I and TVT groups were more satisfied than those in the group therapy (IVT-G), suggesting that individual therapy may be preferred for better patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Patient's Opinion Regarding Different Service Delivery Models for Voice Therapy. Meerschman, I., Van Lierde, K., Claeys, S., et al.[2021]

In a study of 56 patients with voice disorders, the Verbal Instructions Model voice therapy led to significantly greater long-term improvements in voice function, particularly in the physical and emotional aspects, compared to the Imitation Model.

Both therapy models improved voice function overall, but the Verbal Instructions Model showed better outcomes in self-rated Voice Handicap Index scores and voice quality at the end of therapy, indicating it may be more effective for patient learning and adaptation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice Therapy Outcome: A Comparison Between Imitation Model Voice Therapy and Verbal Instructions Model Voice Therapy. Ohlsson, AC., Li, Y., Gustavsson, I., et al.[2022]

Conversation Training Therapy (CTT) is a novel voice therapy approach that emphasizes voice awareness and efficient voice production through patient-driven conversational narratives, rather than following a traditional therapeutic hierarchy.

Developed with input from both expert speech-language pathologists and patients, CTT is grounded in motor learning theory and incorporates six key tenets to enhance spontaneous speech from the very first session.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of Conversation Training Therapy: A Concept Paper. Gartner-Schmidt, J., Gherson, S., Hapner, ER., et al.[2017]

A survey of 55 Speech Language Pathologists (SLPs) in India revealed that most have advanced degrees and primarily work in medical settings, indicating a strong educational background and professional environment for treating voice disorders.

There is a lack of uniformity in voice therapy methods among SLPs, with many modifying their approaches based on client needs, highlighting the necessity for developing standardized, indigenous protocols for voice therapy in India.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An E-Survey of Current Voice Therapy Practices Amongst Speech Language Pathologists (SLPs) in India. Venkatraman, Y., Ganesan, S., Mahalingam, S., et al.[2023]

The Comprehensive Voice Habilitation Program (CVHP) was developed specifically for individuals with hyperfunctional voice disorder (HFVD) in India, incorporating culturally adapted exercises and verified by voice experts, leading to significant improvements in voice quality and function.

Participants in the 6-week program showed notable changes in vocal fold movement and reductions in voice quality issues, demonstrating the efficacy of the tailored therapy approach for HFVD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An eclectic Voice Therapy Program for the Treatment of Hyperfunctional Voice Disorders (HFVD). Boominathan, P., Mahalingam, S., Arunachalam, R., et al.[2023]

The Global Voice Prevention Model (GVPM) was tested with 21 student teachers over 4 weeks, focusing on vocal education and training, and showed promise in improving voice measures using the VoiceEvalU8 app.

Preliminary results indicated changes in fundamental frequency and jitter%, suggesting that both in-person and telepractice conditions may effectively enhance vocal health compared to a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Online Telepractice Model for the Prevention of Voice Disorders in Vocally Healthy Student Teachers Evaluated by a Smartphone Application. Grillo, EU.[2022]

Conversation training therapy (CTT) significantly improved voice handicap perception (measured by the VHI-10) more than standard voice therapy approaches, with notable improvements observed after just 2 sessions compared to 4-8 sessions for traditional methods.

CTT also led to significant enhancements in various acoustic and aerodynamic voice measures, indicating that using spontaneous conversation as a therapeutic approach can effectively address voice disorders in adults with dysphonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Conversation Training Therapy for Patients With Benign Vocal Fold Lesions and Muscle Tension Dysphonia Compared to Historical Matched Control Patients. Gillespie, AI., Yabes, J., Rosen, CA., et al.[2020]

In a pilot study involving 10 transgender women, intensive voice feminization therapy delivered via telepractice resulted in significant improvements in voice characteristics and self-perceived femininity after 12 sessions over 4 weeks.

Participants showed enhanced acoustic measures and better scores on the Trans Woman Voice Questionnaire, indicating that telepractice can be an effective method for voice therapy, although further research with larger groups and control comparisons is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice Outcomes of Intensive Voice Feminization Therapy for Transgender Women Delivered via Telepractice: Pilot Study. Lin, CA., Chen, CH., Tsai, MJ., et al.[2023]

Meta-therapy is a structured approach to voice therapy that uses a standardized framework (Rehabilitation Treatment Specification System) to improve the understanding and delivery of vocal rehabilitation techniques.

The focus of meta-therapy is on changing patients' cognitions and beliefs about their voice, using clinician actions like verbal cues and analogies to shape their mental representations, which can enhance the effectiveness of voice treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping Meta-Therapy in Voice Interventions onto the Rehabilitation Treatment Specification System. Helou, LB., Gartner-Schmidt, JL., Hapner, ER., et al.[2022]

A pilot randomized controlled trial involving 34 participants demonstrated that smartphone-based ecological momentary assessment and intervention (EMA/I) is feasible and acceptable for individuals experiencing distressing voice-hearing, showing good engagement and satisfaction rates.

The study suggests that integrating EMA/I with traditional therapy may improve coping strategies and reduce the severity and negative impact of voice-hearing experiences, indicating potential clinical utility for these digital tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomised controlled trial of a brief coping-focused intervention for hearing voices blended with smartphone-based ecological momentary assessment and intervention (SAVVy): Feasibility, acceptability and preliminary clinical outcomes. Bell, IH., Rossell, SL., Farhall, J., et al.[2021]

A consensus protocol for telerehabilitation in speech therapy for voice disorders was established by experts from the French Society of Phoniatrics and Laryngology, validating 10 key statements on best practices after multiple voting rounds.

The protocol includes recommendations for various aspects of voice therapy and suggests a combination of telerehabilitation and in-office sessions, particularly beneficial for patients in rural areas, especially during or after pandemic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-rehabilitation in voice disorders during the pandemic: a consensus paper from the French Society of Phoniatrics and Laryngology. Baudouin, R., Hans, S., Guiche, M., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical investigation of the Global Voice Therapy Model. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Patient's Opinion Regarding Different Service Delivery Models for Voice Therapy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Voice Therapy Outcome: A Comparison Between Imitation Model Voice Therapy and Verbal Instructions Model Voice Therapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Development of Conversation Training Therapy: A Concept Paper. [2017]

5. India pubmed.ncbi.nlm.nih.gov

An E-Survey of Current Voice Therapy Practices Amongst Speech Language Pathologists (SLPs) in India. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

An eclectic Voice Therapy Program for the Treatment of Hyperfunctional Voice Disorders (HFVD). [2023]

7. United States pubmed.ncbi.nlm.nih.gov

An Online Telepractice Model for the Prevention of Voice Disorders in Vocally Healthy Student Teachers Evaluated by a Smartphone Application. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Conversation Training Therapy for Patients With Benign Vocal Fold Lesions and Muscle Tension Dysphonia Compared to Historical Matched Control Patients. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Voice Outcomes of Intensive Voice Feminization Therapy for Transgender Women Delivered via Telepractice: Pilot Study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Mapping Meta-Therapy in Voice Interventions onto the Rehabilitation Treatment Specification System. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot randomised controlled trial of a brief coping-focused intervention for hearing voices blended with smartphone-based ecological momentary assessment and intervention (SAVVy): Feasibility, acceptability and preliminary clinical outcomes. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Tele-rehabilitation in voice disorders during the pandemic: a consensus paper from the French Society of Phoniatrics and Laryngology. [2023]