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Efficacy and Safety of CBT on Tinnitus

NCT06889259 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-21

No results posted yet for this study

Summary

Tinnitus, the perception of sound without external stimuli, affects 14% of the global population, posing a significant public health concern. This predominantly subjective condition often leads to psychological and physical distress, including anxiety, depression, and insomnia. As tinnitus prevalence rises due to aging populations and increased noise exposure, the need for effective treatments grows urgent.

Current approaches include pharmacological interventions, sound therapy, and cognitive behavioral therapy (CBT), with CBT recognized as most effective for addressing psychological distress. However, traditional therapies face accessibility barriers such as frequent in-person sessions and high costs.

Digital therapeutics, particularly mobile applications, offer promising solutions by providing scalable, accessible interventions. These allow patients to engage in therapy conveniently, accessing real-time, personalized content. Despite advancements, research on digital therapeutics combining CBT and sound therapy for tinnitus remains limited.

This study aims to address this gap by evaluating the clinical efficacy of a mobile application delivering personalized CBT and sound stimulation compared to conventional CBT, potentially contributing to more accessible and effective tinnitus treatment options.

Conditions

  • Tinnitus

Interventions

BEHAVIORAL

CBT based digital therapeutics

The mobile-based digital therapeutic intervention integrated video education, thought record sheets, and sound therapy. This comprehensive treatment was administered five times weekly. The program consisted of a total of 30 sessions.

BEHAVIORAL

Conventional CBT

The cognitive behavioral therapy program for tinnitus, based on a paper manual, was administered five times per week. The treatment regimen consisted of a total of 30 sessions,.

Sponsors & Collaborators

  • Korea University Guro Hospital

    lead OTHER

Principal Investigators

  • Jae-Jun Song · Korea University Guro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06889259 on ClinicalTrials.gov