Clinical trial NCT06584175: Guided ICBT for Adults With Tinnitus in Canada: A Randomized Controlled Trial
Official title: Guided Internet-Delivered Cognitive Behavioural Therapy for Adults With Tinnitus in Canada: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tinnitus
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. have significant cognitive impairments that impact their ability to participate in the therapy;
2. are currently involved in another psychotherapeutic intervention on a regular basis;
3. 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);
4. have tinnitus as a consequence of a medical disorder, still under investigation;
5. are reporting objective, pulsatile, or unilateral tinnitus, which have not been investigated medically;
6. are undergoing any tinnitus therapy concurrently with partaking in this study.

Primary outcomes:
measure: Tinnitus distress
timeFrame: baseline, post-treatment and 3-month follow-up
Secondary outcomes:
measure: Depression
timeFrame: baseline, post-treatment and 3-month follow-up
measure: Anxiety
timeFrame: baseline, post-treatment and 3-month follow-up
measure: Insomnia
timeFrame: baseline, post-treatment and 3-month follow-up
measure: Satisfaction with life
timeFrame: baseline, post-treatment and 3-month follow-up
measure: Hearing Handicap
timeFrame: baseline, post-treatment and 3-month follow-up
measure: Cost effectiveness
timeFrame: 3-month follow-up
measure: Healthcare usage
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
References: