About this trial
clinical trial: The main aim of this study is to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Sound Therapy, both individually and in combination, in the management of patients with chronic subjective tinnitus and to evaluate their impact on decreasing tinnitus severity, psychological wellbeing and quality of life.
Patients will be randomly divided into three groups:
* Group A: patients will receive Sound Therapy. * Group B: patients will receive Cognitive Behavioral Therapy (CBT). * Group C: patients will receive Combined CBT + Sound Therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
o Age: 18-65 years.
Hearing level: Patients with normal hearing or mild to moderate sensorineural hearing loss (to ensure homogeneity of the sample) (National Institute for Health and Care Excellence, 2020)
Complaint: patients with chronic subjective tinnitus (> 3 months).
Psychological state: Patients with stable general and psychological condition.
Disqualifiers
o Age: <18, >65 years
Hearing level: Patients with severe hearing loss not suitable for sound therapy
Complaint: Objective tinnitus (vascular or muscular origin)
Psychological state: Patients with active psychiatric disorders requiring immediate intervention.
Trial design
Parallel
Treatments tested in this trial
Group A: sound therapy
BehavioralGroup A: Sound Therapy * Patients will receive individualized sound therapy using broadband noise or tinnitus maskers. * Daily use recommended for 2-4 hours/day. * Duration: 6 weeks. * Patient will be instructed on habituation-based listening techniques
Group B: Cognitive Behavioral Therapy
BehavioralGroup B: Cognitive Behavioral Therapy (CBT) • Structured CBT program consisting of 6 sessions over 6 weeks. Each session categorization: * Psychoeducation about tinnitus * Cognitive restructuring of negative thoughts * Relaxation techniques (breathing exercises, muscle relaxation) * Attention diversion strategies * Sleep hygiene education
Group C: Combined CBT + Sound Therapy
BehavioralGroup C: Combined Therapy • Patients will receive both sound therapy and CBT simultaneously following the same protocol as above.
Treatment groups
Trial outcomes
Primary outcomes
Primary outcome: Changes in tinnitus severity
Assessment of tinnitus severity using the Tinnitus Functional Index (TFI) . Higher scores indicate greater tinnitus severity. the TFI total score ranges from 0 to 100, with higher score s indicating greater tinnitus severity and functional impact
Secondary outcomes
chang in Visual Analog Scale (VAS) score
Assessment of tinnitus severity using the Visual Analog Scale (VAS) . the VAS score ranges from 0 to 10, with 0 indicate no tinnitus and 10 indicates the worst imaginable tinnitus. higher scores indicating greater tinnitus severity
change in Tinnitus Handicap Inventory (THI) score
Assessment of tinnitus-related handicap and quality of life using Tinnitus Handicap Inventory (THI). the THI total score ranges from 0 to 100, with higher scores indicating greater tinnitus-related handicap and poorer quality of life.
Sponsors and contacts
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