Efficacy and Safety of CBT on Tinnitus

NCT06889259 | Completed DMC

• 1 other identifier: 2023GR0400
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Tinnitus handicap inventory

  The Tinnitus Handicap Inventory is a widely used 25-item self-report questionnaire designed to assess the impact of tinnitus on an individual's daily life. It evaluates functional, emotional, and catastrophic effects of tinnitus, with scores ranging from 0 to 100. Higher score means worse outcome。

  Baseline, 4weeks, 5weeks 6weeks

Study Arms (2)

CBT based digital therapeutics

ACTIVE COMPARATOR

CBT using digital therapeutics

Behavioral: CBT based digital therapeutics

Conventional CBT

SHAM COMPARATOR

Conventional CBT

Behavioral: Conventional CBT

Interventions

CBT based digital therapeutics BEHAVIORAL

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.

CBT based digital therapeutics

Conventional CBT BEHAVIORAL

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,.

Conventional CBT

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjective tinnitus more than 3mo
• age over 19
• Pure tone audiometry \< 60 decibel
• Tinnitus handicap inventory score \> 18

You may not qualify if:

• Objective tinnitus
• Otitis, labyrinthitis
• Depression, Anxiety, Insomnia or other psychiatric disorder
• Pregnancy

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jae-Jun Song

  Korea University Guro Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Multi-center, Randomized, single blind (subject), Parallel, Superiority, Confirmatory Trial

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 21, 2025
• Study Start: January 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)