Actively Recruiting
Internet-Based Mindfulness-Based Cognitive Therapy (iMBCT) for Chronic Tinnitus Patients: a Randomized Controlled Trial Protocol
Led by University of Warsaw · Updated on 2025-09-25
78
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Warsaw
Lead Sponsor
M
Medical University of Warsaw
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an internet-based Mindfulness-Based Cognitive Therapy (MBCT) program designed to help adults experiencing distress related to chronic tinnitus, a condition that causes perception of sound without an external source and can be associated with anxiety, depression, and reduced quality of life. This study compares the six-week online MBCT program to a wait-list control group and aims to measure changes in tinnitus distress, anxiety, depression, mindfulness traits, and self-compassion before and after the intervention, as well as at one and six months following treatment. Participants in the study are randomly assigned to either receive the six-week online MBCT program or be placed on a wait-list. The MBCT program consists of six sequential modules delivered through a secure web platform, including guided mindfulness meditations, body scan, mindful movement, and cognitive-behavioral exercises. Participants access audio recordings, written materials, and reflective tasks without therapist guidance. Those in the wait-list group do not receive active intervention during the six-week period but complete all study assessments at the same time points and are offered the program afterward. During the study, participants complete assessments through an online platform at screening, baseline, post-intervention (week 6), one month later, and six months later. Researchers measure tinnitus distress, anxiety, depression symptoms, acceptance of tinnitus, self-compassion, mindfulness, and emotion regulation. The study includes regular monitoring and provides support if participants experience crisis, with referrals to clinical services as needed. Total participation covers initial screening through six months of follow-up.
CONDITIONS
Brief Title
Internet-Based Mindfulness-Based Cognitive Therapy (iMBCT) for Chronic Tinnitus Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness and ability to participate in online therapy
- Polish language proficiency
- 18 years or older
- Suffering from chronic tinnitus for at least 3 months
- A score of 6532 on the TFI (Tinnitus Functional Index)
You will not qualify if you...
- Mentally incapable patients
- Patients who have already completed structured mindfulness training
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (online)
Duration - 6 weeks
Participants undergo a 6-week internet-delivered Mindfulness-Based Cognitive Therapy (iMBCT) program consisting of six online modules with mindfulness meditations and cognitive-behavioral exercises. Participants complete the program independently without therapist guidance.
Assessments at baseline and post-intervention (online)
Duration - Up to 6 months post-treatment
Participants complete follow-up assessments to evaluate maintenance of treatment effects on tinnitus distress, anxiety, and depression at 1 month and 6 months after the intervention.
2 online visits (1-month and 6-month follow-ups)
Trial Site Locations
Total: 1 location
1
Faculty of Psychology, University of Warsaw
Warsaw, Poland, 00-927
Actively Recruiting
Research Team
P
Paweł Holas, MD PhD
W
Weronika Joanna Caban, student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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