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

NCT06584175 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-04-13

No results posted yet for this study

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.

Conditions

  • Tinnitus

Interventions

BEHAVIORAL

Internet Delivered Cognitive Behavioural Therapy

The tinnitus ICBT program consists of 1) an overview of tinnitus, depression, and anxiety; 2) managing unhelpful thoughts and learning problem solving strategies association with pain, anxiety, depression, and disability; 3) management of common symptoms associated with tinnitus, anxiety, and depression; 4) developing strategies to maintain activities while minimizing fatigue; and 5) strategies to improve quality of life through effective goal setting. Supplementary lessons can be accessed at any time (e.g., sleep, communication, problem solving, assertiveness training). Materials are presented in a didactic (i.e., text-based and audio with visual images) and case-enhanced learning format (i.e., stories demonstrate the application of skills). Case vignettes that specifically reflect the experiences of those with tinnitus are included.

Sponsors & Collaborators

  • Western University, Canada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-03-30
Completion
2026-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06584175 on ClinicalTrials.gov