Home » Trials » SLCTR/2018/005

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


SLCTR Registration Number


Date of Registration

02 Feb 2018

The date of last modification

Mar 03, 2019

Application Summary

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 or Health Condition(s) Studied


Scientific Acronym


Public Acronym


Brief title

CBT for Tinnitus

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

P/257/10/2017 (ERC: Kelaniya)

Trial Details

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


Study design


Randomized controlled trial


Double blinded


Standard therapy/practice





Study Phase

Phase 1-2

Intervention(s) planned

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.

Inclusion criteria

  1. Male and female consenting adult patients (Over the age of 18 years)
  2. Unilateral or bilateral tinnitus lasting for at least 6 months at the commencement of the study.

Exclusion criteria

  1. Inability to converse in the Sinhala language
  2. Subjects who have not attained a basic educational level i.e. who are unable to complete the questionnaires alone.
  3. Individuals who have had previously received psychological treatment for their tinnitus.
  4. Subjects with otherwise treatable tinnitus
  5. Subjects who had a history of psychotic disorders or dementia

Primary outcome(s)


Severity and handicap level of tinnitus using the Tinnitus Handicap Inventory


At baseline, 4 weeks after initiation and 24 weeks after initiation of the intervention


Secondary outcome(s)


Potential non-psychotic or psychological problems using General Health Questionnaire - 12


At baseline and 6 months after initiation of the intervention


Target number/sample size

110 (55 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

None (Investigator funded)

Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 6, Thalagolla Road, Ragama Sri Lanka
Email: erckelaniya@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. Asiri Rodrigo
Consultant Psychiatrist
Department of Psychiatry, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
Tel: 0112961115
Mob: 0777865791
Fax: 0112958837

Contact Person for Public Queries

Thilini Abayabandara Herath
Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.

Mob: 0712570862


Primary study sponsor/organization

Faculty of Medicine, University of Kelaniya

P.O Box 6 Thalagolla Road Ragama Sri Lanka
Tel: 0112961115
Fax: 0112958837

Secondary study sponsor (If any)


Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Not available

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results