Efficacy of Internet-based Cognitive Behavioral Therapy for Insomnia in Patients With Tinnitus and Insomnia

A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Insomnia Versus Patient Education in Patients With Tinnitus and Insomnia

This single-center, single-blind, randomized controlled trial is designed to evaluate the efficacy of therapist-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I) compared with patient education in patients with chronic subjective tinnitus and clinically significant insomnia. A total of 168 participants will be randomized in a 1:1 ratio to receive either an 8-week internet-based CBT-I intervention or an online patient education intervention. The primary outcome is the between-group mean difference in Tinnitus Handicap Inventory (THI) score at 2 months after randomization. Secondary outcomes include insomnia severity, subjective sleep parameters, tinnitus loudness, anxiety and depression symptoms, and dysfunctional beliefs and attitudes about sleep. Participants will be assessed at baseline, 1 month, 2 months, 3 months, and 5 months.

Inclusion Criteria:

• Adults aged between 18 and 65 years;
• Diagnosis of chronic subjective tinnitus persisting for at least 6 months;
• A score of 38 or higher on the Tinnitus Handicap Inventory (THI);
• An Insomnia Severity Index (ISI) score of 8 or higher;
• Ability to understand the study procedures and provide informed consent;
• Proficiency in reading and writing Chinese;
• Access to a smartphone for participation in the digital intervention.

Exclusion Criteria:

• Objective or pulsatile tinnitus;
• Specific otologic conditions requiring immediate medical treatment, such as sudden sensorineural hearing loss;
• Diagnosed organic sleep disorders, such as obstructive sleep apnea;
• Serious psychiatric disorders, including schizophrenia;
• Concurrent enrollment in another clinical trial targeting tinnitus or insomnia.