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NCT Number: NCT06584175

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

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western University

London, Ontario, Canada

About this study

Tinnitus is a condition where people hear sounds like ringing or buzzing without an external sound producing source. Tinnitus affects millions globally and is linked to poor mental health, including depression, anxiety, and insomnia. Current treatments have limited success, and Cognitive Behavioral Therapy (CBT) is the most effective, though rarely available.

The study aims to test a personalized, internet-delivered CBT (ICBT) program for tinnitus sufferers in Canada. This program could offer a cost-effective, accessible treatment option. The study will compare a personalized ICBT program with a standard ICBT program to evaluate their effectiveness in reducing tinnitus distress and improving related conditions like depression, anxiety, insomnia and quality of life.

The study will involve 82 participants, who will be randomly assigned to either the personalized or standard ICBT group. Both groups will receive guided support over eight weeks. The research hopes to demonstrate that the personalized ICBT is as effective as the standard ICBT program, but with added benefits in convenience and cost.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults (18-79 years);
  • diagnosed with tinnitus for more than 6 months;
  • ability to read and write in English;
  • cognitive capacity to consent and participate in the therapeutic process;
  • able to access the technology required for the program (telephone, computer, internet);
  • Canadian residents;
  • A score of 25 or above on the Tinnitus Functional Index (TFI) suggesting the need for tinnitus care.

Exclusion criteria

  • have significant cognitive impairments that impact their ability to participate in the therapy;
  • are currently involved in another psychotherapeutic intervention on a regular basis;
  • present with severe mental health disorder that would be better treated in person (e.g., severe suicide ideation, severe substance abuse, recent history of psychosis, mania);
  • have tinnitus as a consequence of a medical disorder, still under investigation;
  • are reporting objective, pulsatile, or unilateral tinnitus, which have not been investigated medically;
  • are undergoing any tinnitus therapy concurrently with partaking in this study.

Treatment and study plan

Internet Delivered Cognitive Behavioural Therapy

Behavioral

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.

Primary outcomes

  1. Tinnitus distress

    Time frame: baseline, post-treatment and 3-month follow-up

    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.

Secondary outcomes

  1. Depression

    Time frame: baseline, post-treatment and 3-month follow-up

    The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression. Low scores indicate low severity and high scores indicate high severity.

  2. Anxiety

    Time frame: baseline, post-treatment and 3-month follow-up

    Generalized Anxiety Disorder-7 (GAD-7) will be used to measure anxiety. Low scores indicate low severity and high scores indicate high severity.

  3. Insomnia

    Time frame: baseline, post-treatment and 3-month follow-up

    Insomnia Severity Index (ISI) will be used to measure insomnia. Low scores indicate low severity and high scores indicate high severity.

  4. Satisfaction with life

    Time frame: baseline, post-treatment and 3-month follow-up

    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.

  5. Hearing Handicap

    Time frame: baseline, post-treatment and 3-month follow-up

    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.

  6. Cost effectiveness

    Time frame: 3-month follow-up

    Productivity Cost Questionnaire (iPCQ) will be used to measure cost-effectiveness.

  7. Healthcare usage

    Time frame: 3-month follow-up

    Medical Consumption Questionnaire (iMCQ) will be used to measure health care usage

Study contacts

Contact information is provided by the study sponsor or research team.

Frank Ocran, MSc.

CONTACT

[email protected]

2265037582

Swati Mehta, PhD

CONTACT

[email protected]

5196858500 ext. 42359

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

Guided Internet-Delivered Cognitive Behavioural Therapy for Adults With Tinnitus in Canada: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2024
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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