Ignite Creation Date:
2024-10-25 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584175
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Online CBT for Tinnitus in Adults a Canadian Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Guided Internet-Delivered Cognitive Behavioural Therapy for Adults with Tinnitus in Canada a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None