TinnitusNCT06584175
Guided ICBT for Adults With Tinnitus in Canada: A Randomized Controlled Trial
A study testing Internet Delivered Cognitive Behavioural Therapy in people with Tinnitus, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Internet Delivered Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Internet-Delivered Cognitive Behavioural Therapy 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?
Read more
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.
Read the detailed description
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.
- Conditions
- Tinnitus
- Being tested
- Internet Delivered Cognitive Behavioural Therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet Delivered Cognitive Behavioural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized ICBT | Experimental | Before initiation of the program, participants in the personalized ICBT group will collaboratively work with the Guide to determine which modules of the ICBT program best meet the participant's needs/goals. The ICBT program contains a total of 21 modules. Once modules have been selected, the Guide will develop a personalized program for the participant. The participant will then be enrolled into the personalized program. Participants in this group will receive guided support by video chat or phone each week (based on participant's preference) by a trained Guide over the 8-week duration of the program. Weekly contact will include motivating participants to complete the weekly lessons and assistance on the practicing/application of the skills. The Guide will spend approximately 10-15 minutes per week with each participant. Receives: Behavioral: Internet Delivered Cognitive Behavioural Therapy |
| Standard ICBT | Active comparator | Participants in the standard group will receive the ICBT program (containing 21 modules) as is. No personalization will be provided. Similar to the personalized ICBT group, participants will receive guided support by video chat or phone each week (based on participant's preference) by a trained Guide over the 8-week duration of the program. Weekly contact will include motivating participants to complete the weekly lessons and assistance on the practicing/application of the skills. The Guide will spend approximately 10-15 minutes per week with each participant. Receives: Behavioral: Internet Delivered Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, post-treatment and 3-month follow-up
Secondary outcomes (7)
Depression
The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression. Low scores indicate low severity and high scores indicate high severity.
Measured: baseline, post-treatment and 3-month follow-up
Anxiety
Generalized Anxiety Disorder-7 (GAD-7) will be used to measure anxiety. Low scores indicate low severity and high scores indicate high severity.
Measured: baseline, post-treatment and 3-month follow-up
Insomnia
Insomnia Severity Index (ISI) will be used to measure insomnia. Low scores indicate low severity and high scores indicate high severity.
Measured: 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.
Measured: 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.
Measured: baseline, post-treatment and 3-month follow-up
Cost effectiveness
Productivity Cost Questionnaire (iPCQ) will be used to measure cost-effectiveness.
Measured: 3-month follow-up
Healthcare usage
Medical Consumption Questionnaire (iMCQ) will be used to measure health care usage
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start15 Sep 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584175
- Sponsor's protocol ID
- 123792
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Internet-Delivered Cognitive Behavioural Therapy for Adults With Tinnitus in Canada: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06584175
- Acronym / sponsor ID
- 123792
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized ICBT | Experimental | Behavioral: Internet Delivered Cognitive Behavioural TherapyBefore initiation of the program, participants in the personalized ICBT group will collaboratively work with the Guide to determine which modules of the ICBT program best meet the participant's needs/goals. The ICBT program contains a total of 21 modules. Once modules have been selected, the Guide will develop a personalized program for the participant. The participant will then be enrolled into the personalized program. Participants in this group will receive guided support by video chat or phone each week (based on participant's preference) by a trained Guide over the 8-week duration of the program. Weekly contact will include motivating participants to complete the weekly lessons and assistance on the practicing/application of the skills. The Guide will spend approximately 10-15 minutes per week with each participant. |
| Standard ICBT | Active comparator | Behavioral: Internet Delivered Cognitive Behavioural TherapyParticipants in the standard group will receive the ICBT program (containing 21 modules) as is. No personalization will be provided. Similar to the personalized ICBT group, participants will receive guided support by video chat or phone each week (based on participant's preference) by a trained Guide over the 8-week duration of the program. Weekly contact will include motivating participants to complete the weekly lessons and assistance on the practicing/application of the skills. The Guide will spend approximately 10-15 minutes per week with each participant. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet Delivered Cognitive Behavioural TherapyThe 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. | Behavioural | Personalized ICBT, Standard ICBT |
Primary outcome
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.
7 secondary outcomes
Depression
Time frame: baseline, post-treatment and 3-month follow-up
Anxiety
Time frame: baseline, post-treatment and 3-month follow-up
Insomnia
Time frame: baseline, post-treatment and 3-month follow-up
Satisfaction with life
Time frame: baseline, post-treatment and 3-month follow-up
Hearing Handicap
Time frame: baseline, post-treatment and 3-month follow-up
Cost effectiveness
Time frame: 3-month follow-up
Healthcare usage
Time frame: 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet Delivered Cognitive Behavioural Therapy in people with Tinnitus, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Swati Mehta, PhD (5196858500 ext. 42359, swati.mehta@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus distress (time frame: baseline, post-treatment and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.