Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07183826

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

You will not qualify if you...

  • Mentally incapable patients
  • Patients who have already completed structured mindfulness training

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (online)

Treatment

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)

Follow-up

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

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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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