Guided ICBT for Tinnitus

Overseen By Frank Ocran, MSc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Severe mental health, Cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently involved in another regular psychotherapeutic intervention or undergoing any tinnitus therapy.

Is Guided Internet-delivered Cognitive Behavioural Therapy (ICBT) safe for humans?

Research on Guided Internet-delivered Cognitive Behavioural Therapy (ICBT) for tinnitus has not reported any unwanted events or safety concerns, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How is Guided Internet-delivered Cognitive Behavioural Therapy (ICBT) for tinnitus different from other treatments?

Guided ICBT for tinnitus is unique because it is delivered over the Internet, making it more accessible to people who may not have easy access to face-to-face therapy. It involves guidance from a specialist, such as an audiologist, and focuses on reducing the distress caused by tinnitus through cognitive and behavioral techniques. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Guided Internet-delivered Cognitive Behavioural Therapy for tinnitus?

Research shows that Guided Internet-delivered Cognitive Behavioural Therapy (ICBT) is effective for reducing tinnitus distress, with positive long-term outcomes observed one year after treatment. Additionally, ICBT is considered an evidence-based intervention for tinnitus, indicating its overall effectiveness. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-79 in Canada who have had tinnitus for over 6 months, can read and write English, are mentally able to consent and participate, have the needed tech (phone, computer, internet), and score at least 25 on the TFI indicating they need tinnitus care.

Inclusion Criteria

I can read and write in English.

I have access to a phone, computer, and internet.

I am a resident of Canada.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a personalized or standard ICBT program delivered over 8 weeks, consisting of 21 modules with guided support of 10-15 minutes per week by video chat or phone.

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment through online surveys at 3-month follow-up.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Guided Internet-delivered Cognitive Behavioural Therapy

Trial Overview The study tests if guided Internet-delivered Cognitive Behavioural Therapy helps with distress from tinnitus and related issues like anxiety or poor sleep. It compares a personalized ICBT program against a standard one over an 8-week course with weekly guide support.

How Is the Trial Designed?

Group I: Personalized ICBT Experimental Treatment 1 Intervention

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.

Group II: Standard ICBT Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Published Research Related to This Trial

Internet-based cognitive behavioral therapy (ICBT) for tinnitus was successfully translated into Spanish, showing a large effect size (d = 0.90) in reducing tinnitus severity among 32 participants, indicating its potential effectiveness for Spanish speakers.

While the intervention was feasible, with no withdrawals, engagement and compliance were not optimal, suggesting the need for improvements in these areas and further research through a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioural therapy for tinnitus in Spanish: a global feasibility trial. Beukes, EW., Munzo, MF., Andersson, G., et al.[2022]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term efficacy of audiologist-guided Internet-based cognitive behaviour therapy for tinnitus in the United States: A repeated-measures design. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Internet-based cognitive-behavioural therapy for tinnitus: secondary analysis to examine predictors of outcomes. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioural therapy for tinnitus in Spanish: a global feasibility trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Dismantling internet-based cognitive behavioral therapy for tinnitus. The contribution of applied relaxation: A randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Long-Term Efficacy of Audiologist-Guided Internet-Based Cognitive Behavior Therapy for Tinnitus. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Internet-based guided self-help versus group cognitive behavioral therapy for chronic tinnitus: a randomized controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Audiologist-Guided Internet-Based Cognitive Behavior Therapy for Adults With Tinnitus in the United Kingdom: A Randomized Controlled Trial. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Development and technical functionality of an Internet-based intervention for tinnitus in the UK. [2022]