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Guided ICBT for Adults With Tinnitus in Canada: A Randomized Controlled Trial

NCT06584175 NA NOT_YET_RECRUITING

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.

Details

Lead sponsorWestern University, Canada
PhaseNA
StatusNOT_YET_RECRUITING
Enrolment82
Start dateMon Sep 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionMon Aug 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Canada