Guided ICBT for Adults With Tinnitus in Canada: A Randomized Controlled Trial
ConditionTinnitus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorWestern University, Canada
About 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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Internet Delivered Cognitive Behavioural Therapy
Treatment groups
82 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov