Online CBT for Tinnitus Among Canadian Adults: a Randomized Controlled Trial
NCT Number: NCT06584175
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tinnitus
Sponsor: Western University, Canada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-15
Completion Date: 2025-12-31

Summary:
The goal of this randomized controlled trial is to learn if guided Internet-delivered Cognitive Behavioural Therapy can treat tinnitus-related distress and its associated comorbidities such as anxiety, depression, insomnia, and quality of life among adult tinnitus patients in Canada. The main questions it aims to answer are:

* Does guided internet-delivered cognitive behavioural therapy for the treatment of tinnitus reduce tinnitus-related distress and tinnitus-associated comorbidities (depression, anxiety, insomnia, quality of life) among adult tinnitus patients aged 18-79 years in Canada from pre-treatment to post-treatment and 3-month follow-up?
* Do participants in the personalized ICBT treatment group show worse improvements in patient-reported outcomes from pre-treatment to post-treatment and 3-month follow-up than the standard ICBT control group?

The researchers will compare a personalized ICBT program to a standard ICBT program to investigate if participants in the personalized ICBT program will show no worse improvements in patient-reported outcomes from pre-treatment to post-treatment and 3-month follow-up than the active comparator, the standard ICBT program.

Participants will:

* Receive either a personalized ICBT program or a standard ICBT program delivered over 8 weeks consisting of 21 modules.
* Receive guided support of approximately 10-15 minutes per week by video chat or phone from a trained Guide over the 8-week duration of the program.
* Complete assessments at baseline, post-intervention, and 3-month follow-up through online REDCap surveys with automatic emails and telephone reminders.

Primary Outcome Measures: Tinnitus distress, The primary assessment measure to quantify distress will be the Tinnitus Functional Index (TFI). A 13-point change in TFI scores will be identified as a clinically meaningful/significant change. Low scores indicate low severity and high scores indicate high severity., baseline, post-treatment and 3-month follow-up
Secondary Outcome Measures: Depression, The Patient Health Questionnaire-9 (PHQ-9) for depression will be used to measure depression. Low scores indicate low severity and high scores indicate high severity., baseline, post-treatment and 3-month follow-up|Anxiety, Generalized Anxiety Disorder-7 (GAD-7) for anxiety will be used to measure anxiety. Low scores indicate low severity and high scores indicate high severity., baseline, post-treatment and 3-month follow-up|Insomnia, Insomnia Severity Index (ISI) for insomnia will be used to measure insomnia. Low scores indicate low severity and high scores indicate high severity., baseline, post-treatment and 3-month follow-up|Satisfaction with life, Satisfaction with Life Scales (SWLS) for satisfaction with life will be used to measure satisfaction with life. Low scores indicate low satisfaction and high scores indicate high satisfaction., baseline, post-treatment and 3-month follow-up|Hearing Handicap, Hearing Handicap Inventory for Adults Screening version (HHIA-S) will be used to measure hearing handicap. Low scores indicate low severity and high scores indicate high severity., baseline, post-treatment and 3-month follow-up|Cost effectiveness, Productivity Cost Questionnaire (iPCQ) will be used to measure cost-effectiveness., 3-month follow-up|Healthcare usage, Medical Consumption Questionnaire (iMCQ) will be used to measure health care usage, 3-month follow-up