Date

2020-09-14

Protocol

Protocol changed

Item Changed

1. Scientific Title of Trial 2. What is the research question being addressed? 3. Intervention(s) planned 4. Inclusion criteria 5. Exclusion criteria 6. Secondary outcome(s) 7. Target number/sample size 8. Primary study sponsor/organization

Previous Version

1. Effectiveness of modified cognitive behavioral therapy (CBT) in reducing distress for patients with tinnitus who are receiving treatment at two tertiary care hospitals in Sri Lanka, a randomised controlled trial 2. Is modified cognitive behavioral therapy effective in reducing distress in patients with chronic tinnitus who are receiving treatment at 2 tertiary care hospitals of Sri Lanka? 3. Patients assigned to the experimental group will receive four individual sessions of cognitive behavioral therapy (CBT) over 4 weeks. The control group will receive standard care. Standard care involves audiological measurement and brief education. 4. Male and female consenting adult patients (Over the age of 18 years), Unilateral or bilateral tinnitus lasting for at least 6 months at the commencement of the study. 5. Inability to converse in the Sinhala language; Subjects who have not attained a basic educational level i.e. who are unable to complete the questionnaires alone; Individuals who have had previously received psychological treatment for their tinnitus; Subjects with otherwise treatable tinnitus; Subjects who had a history of psychotic disorders or dementia 6. Potential non-psychotic or psychological problems using General Health Questionnaire - 12 [At baseline and 6 months after initiation of the intervention] 7. 110 (55 in each arm) 8. Faculty of Medicine, University of Kelaniya, P.O Box 6 Thalagolla Road Ragama Sri Lanka, Tel: 0112961115, Fax: 0112958837, info.med@kln.ac.lk, http://medicine.kln.ac.lk/

Next Version

1. Effectiveness of Culturally Modified Cognitive Behavioral Therapy (CBT) for Patients with Tinnitus in Sri Lanka, a randomized control trial 2. Does culturally modified cognitive behavioural therapy is an effective treatment for patients with tinnitus in Sri Lanka? 3. 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 4. Consenting adult patients (Over the age of 18 years) who complain of chronic unilateral or bilateral tinnitus lasting for at least 6 months before examination in ENT clinics. 5. • People who are not conversant in Sinhala language and have not attained a basic educational level i.e. who are unable to complete the questionnaires alone; • Individuals must never have previously received psychological treatment for their tinnitus; • Subjects with otherwise treatable tinnitus were excluded (Patients with conductive pathologies such as impacted ear wax); • Subjects who had a history of psychotic disorders or dementia were excluded. 6. Potential non-psychotic or psychological problems using General Health Questionnaire - 12 [At baseline, 4 weeks after initiation and 24 weeks (6 months) after initiation of the intervention] 7. 90 (45 in each arm) 8. None