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Effect of Audiologist-guided Internet-based cognitive behavioral therapy for Tinnitus

Effectiveness of Audiologist-guided Internet-based cognitive behavioral therapy in Kannada for individuals with Tinnitus A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087487
Enrollment
90
Registered
2025-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H60-H95- Diseases of the ear and mastoid process

Interventions

Intervention1: Audiologist-guided Internet-based Cognitive Behavioral Therapy: Its an 8-week online intervention program. It is self-paced, and an audiologist is available throughout the program to mo

Sponsors

Keerthana R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i) Individuals who are living in India ii) Individuals with continuous and bothersome tinnitus for at least 3 months iii) Mild or higher degree of tinnitus distress in Tinnitus Functional Index (TFI) iv) Have completed schooling (12th standard) v) Ability to read and comprehend Kannada vi) Access to a computer and the Internet and the ability to browse and send e-mails

Exclusion criteria

Exclusion criteria: i) Tinnitus associated with conductive, neurological causes and objective tinnitus ii) Individuals under other interventions, including medical management for tinnitus iii) Score of 15 and above on the Patient Health Questionnaire (PHQ-9) for depression and Generalized Anxiety Disorder (GAD-7) for anxiety, indicating a high need for direct psychological intervention. iv) Individuals with a score of 25 or less in the Montreal Cognitive Assessment (MoCA) indicating the need for medical attention for mild cognitive impairment.

Design outcomes

Primary

MeasureTime frame
Tinnitus severity - i) Tinnitus Functional Index (TFI) ii) Visual Analogue scale (VAS)Timepoint: i) 3 Time points: Baseline, 8 weeks, 16 weeks ii) 6 time points: baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 16 weeks

Secondary

MeasureTime frame
i) Anxiety (Generalized Anxiety Disorder 7), Depression (Patient Health Questionnaire 9), sleep quality (Pittsburg Sleep Quality Index), Hearing & communication difficulty (Hearing Handicap Index), Overall quality of life (WHOQOL BREF)Timepoint: i) 3 time points: baseline, 8 weeks, 16 weeks;ii) Questionnaire for the impact of tinnitus on daily lifeTimepoint: ii) 6 Time points: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 16 weeks;iii) Neuropsychological correlates - Spectral power changes & EEG connectivity measuresTimepoint: iii) 2 Time points - Baseline, 8 weeks;iv) Satisfaction of program questionnaireTimepoint: iv) 1 Time point: 8 weeks

Countries

India

Contacts

Public ContactDr Hari Prakash P

Manipal Academy of Higher Education

hari.prakash@manipal.edu9886135522

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026