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
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SLCTR Registration Number
SLCTR/2018/005
Date of Registration
The date of last modification
Aug 31, 2021
Trial Status
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
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)
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/practice
Assignment
Parallel
Purpose
Treatment
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
Exclusion criteria
Primary outcome(s)
|
1.
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)
|
1.
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
2018-02-05
Anticipated end date
2018-12-31
Date of first enrollment
2020-10-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None (Investigator funded)
Regulatory approvals
Status
Approved
Date of Approval
2017-11-14
Approval number
P/257/10/2017
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 |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
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/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Yes
Protocol version and date
Version 4, Date 2020-01-21
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
