Trial of Management of Chronic Tinnitus by Sound Therapy and Cognitive Behavioral Therapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSohag University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Group A: sound therapy

    Behavioral

    Group 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

    Behavioral

    Group 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

    Behavioral

    Group C: Combined Therapy • Patients will receive both sound therapy and CBT simultaneously following the same protocol as above.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Group A: patients will receive Sound TherapyActive comparator 1 intervention
Group B: Group B: patients will receive Cognitive Behavioral Therapy (CBT).Active comparator 1 intervention
Group C: Group C: patients will receive Combined CBT + Sound Therapy.Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, immediately after completion of treatment , and 3 months after completion of treatment

Secondary outcomes

1

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

Time frame
Baseline, immediately after completion of treatment , and 3 months after completion of treatment
2

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.

Time frame
Baseline, immediately after completion of treatment , and 3 months after completion of treatment

Other outcomes

Sponsors and contacts

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