SLCTR Registration Number
Date of Registration
The date of last modification
Feb 02, 2018
Scientific Title of Trial
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
Public Title of Trial
Effectiveness of Cognitive Behavioral Therapy for Tinnitus
Disease of Health Condition(s) Studied
CBT for Tinnitus
Universal Trial Number
Any other number(s) assigned to the trial and issuing authority
P/257/10/2017 (ERC: Kelaniya)
What is the research question being addressed?
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?
Type of study
Randomized controlled trial
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.
Severity and handicap level of tinnitus using the Tinnitus Handicap Inventory
Primary outcome(s) - Time of assessment(s)
At baseline, 4 weeks after initiation and 24 weeks after initiation of the intervention
Potential non-psychotic or psychological problems using General Health Questionnaire - 12
Secondary outcome(s) - Time of assessment(s)
At baseline and 6 months after initiation of the intervention
Target number/sample size
110 (55 in each arm)
Countries of recruitment
Anticipated start date
Anticipated end date
State of ethics review approval
Approved by the Ethical Review Committee of Faculty of Medicine, University of Kelaniya on 24th November 2017 (Ref. P/257/10/2017)
None (Investigator funded)
Contact person for Scientific Queries/Principal Investigator
Dr. Asiri Rodrigo
Department of Psychiatry, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
Contact Person for Public Queries
Thilini Abayabandara Herath
Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.