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

NCT06584175 | Not Yet Recruiting

• 1 other identifier: 123792
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, post-treatment and 3-month follow-up

Secondary Outcomes (7)

• Depression

  baseline, post-treatment and 3-month follow-up

• Anxiety

  baseline, post-treatment and 3-month follow-up

• Insomnia

  baseline, post-treatment and 3-month follow-up

• Satisfaction with life

  baseline, post-treatment and 3-month follow-up

• Hearing Handicap

  baseline, post-treatment and 3-month follow-up

Study Arms (2)

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.

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.

Behavioral: Internet Delivered Cognitive Behavioural Therapy

Interventions

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.

Personalized ICBT; Standard ICBT

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Western University

London, Ontario, Canada

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Swati Mehta, PhD

CONTACT

5196858500; swati.mehta@sjhc.london.on.ca

Frank Ocran, MSc.

CONTACT

2265037582; focran@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 4, 2024
• Study Start: September 15, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 13, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)