Date

2020-06-02

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Study sites: Colombo North Teaching Hospital, Ragama and Gampaha Hospital Stratified block randomization will be used. Participants will be grouped into strata according to age and gender, and allocated in blocks to either intervention or control groups. Random allocation will be done by an independent person who is not directly involved in the research. The participant, treating clinician or researcher will have no influence over randomisation or allocation. Patients assigned to the experimental group will receive four individual sessions of cognitive behavioral therapy (CBT) over 4 weeks, with each session lasting 45 minutes. The objectives of the CBT will be reducing selective attention and monitoring for tinnitus-related cues, reducing anxiety and hyperarousal, correcting counterproductive safety behaviors, correcting negative automatic thoughts, correcting distorted perceptions of tinnitus intensity and its impact on functioning and correcting inaccurate beliefs. The CBT will follow a structured manual which will comprise of these components: • Brief focused assessment • Education • Relaxation • Activity scheduling • Cognitive restructuring • Mindfulness CBT sessions will be conducted at a mutually convenient time at the hospital premises by audiologists and psychiatrists trained in CBT. In order to ensure all the participating therapists are following the manual, therapists will have regular group supervision during the study. The control group will receive standard care. Standard care involves audiological measurement and brief education. Subsequent assessment will be carried out at the end of the treatment (4 weeks) after 6 months. Assessment would include THI and GHQ-12 scores and psychoacoustic measurements. Outcome assessors and data analysts will be blinded to the intervention status of the participants.

Next Version

Patients assigned to this control group will receive only standard care. Standard care involves otoscopic examination and brief education during the standard care appointment. An experimental group will also receive otoscopic examination and they will receive four CBT individual sessions over 4 weeks