Online Intervention for Muscle Tension Dysphonia A Pilot Randomized Clinical Trial

Importance Voice-related perceived control is the extent to which a person feels they can control their voice condition and/or their response to it. Given the interaction of psychological factors and voice outcomes, an intervention targeting psychological factors may be a helpful adjunct to clinical voice care. Objective To investigate the feasibility, acceptability, and potential efficacy of a perceived control intervention adapted for adult patients with muscle tension dysphonia and to compare its outcomes with those of a voice education program. Design, Settings, and Participants This was a pilot randomized clinical trial using mixed methods and including adults with muscle tension dysphonia from academic otolaryngology clinics from July 8, 2018, to December 8, 2019. Participants were randomized to the voice education program or the perceived control intervention, and feasibility and acceptability of both were assessed using quantitative and qualitative measures. Data analyses were performed from October 1, 2023, to March 5, 2024. Main Outcomes and Measures Voice-related impairment was measured using the Voice Handicap Index-10 (VHI-10). Psychological factors were measured using the voice-related Perceived Present Control Scale, Brief Symptom Inventory-18 (BSI), and Perceived Stress Scale-4. Open-ended participant responses were analyzed following consensual qualitative research methods. Results In all, 50 participants (mean [SD] age, 51.0 [15.9] years; 34 women [68%]); 27 were randomly assigned to receive the voice education program and 23 were randomly assigned to the perceived control intervention. Forty participants (80%) completed the study, which demonstrated the feasibility of both options. Outcomes of both the perceived control intervention and the voice education program were acceptable. Change in VHI-10 was heterogeneous, modest overall, and similar in the perceived control (-2.44; 95% CI, -4.25 to -0.63) and education (-2.94; 95% CI, -4.12 to -1.76) arms. Perceived control (secondary outcome) was higher, and exploratory outcomes (ie, somatic concerns, depression, anxiety, and perceived stress) were lower overall between pretest and posttest assessments. Qualitative analyses showed an overall decrease in negative voice-related emotions, fatigue, and negative self-image over the course of the perceived control intervention, and an interest in curated information in the voice education program. Conclusions and Relevance This pilot randomized clinical trial indicates that both the perceived control intervention and voice education program appear promising for further development. Online interventions are of interest to people with voice disorders, and future work may benefit from taking individual differences into account. Trial Registration ClinicalTrials.gov Identifier: NCT03576365