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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

SLCTR/2018/005


Date of Registration

02 Feb 2018

The date of last modification

Feb 02, 2018



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 of Health Condition(s) Studied

Tinnitus


Scientific Acronym

None


Public Acronym

None


Brief title

CBT for Tinnitus


Universal Trial Number

U1111-1203-6218


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Standard therapy


Assignment

Parallel


Purpose

Treatment


Purpose

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


Primary outcome(s) - Time of assessment(s)

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


Secondary outcome

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

Sri Lanka


Anticipated start date

2018-02-05


Anticipated end date

2018-12-31


Recruitment status

Pending


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)


Funding source

None (Investigator funded)



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
asirir2000@yahoo.com

Contact Person for Public Queries

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

Mob: 0712570862

chatuima@gmail.com


Primary study sponsor/organization

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/

Secondary study sponsor (If any)

None