Internet-Based Mindfulness-Based Cognitive Therapy (iMBCT) for Chronic Tinnitus Patients

NCT ID: NCT07183826

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-06-19

Brief Summary

This study tested a 6-week, internet-based Mindfulness-Based Cognitive Therapy (MBCT) program designed to help people experiencing distress related to chronic tinnitus. Tinnitus is condition that can cause anxiety, depression, and negatively impact the quality of life.

The investigators compare the online MBCT program to a wait-list group. Study aims to measure tinnitus distress, symptoms of anxiety, depression, mindfulness traits, and self-compassion before the program, right after, one month later, and six months later.

Detailed Description

Tinnitus, the perception of sound without an external source, affects about 10-15% of people worldwide, with 2-3% experiencing severe distress. Large studies estimate that around 14% of adults report tinnitus, and about 2% suffer from a disabling form. In Europe, roughly one in seven adults is affected. Tinnitus often occurs alongside anxiety, depression, insomnia, and reduced quality of life. Even mild tinnitus has been linked to poorer sleep and higher levels of anxiety and depression.

Despite extensive research, there is no universal medical cure for tinnitus. As a result, treatment increasingly focuses on psychological and behavioral methods that aim to reduce distress and promote habituation. Cognitive Behavioral Therapy (CBT) is the current gold standard, reliably easing distress and improving coping, though it is not effective for everyone and access remains limited. This has led to growing interest in mindfulness-based approaches, such as Mindfulness-Based Cognitive Therapy (MBCT), which combine mindfulness practices with cognitive strategies focused on acceptance rather than control of symptoms.

Mindfulness-based treatments target the negative thoughts, catastrophic interpretations, and avoidance behaviors that sustain tinnitus distress. Acceptance of tinnitus has been shown to improve quality of life and reduce depression and distress. By fostering non-judgmental awareness of the present moment, MBCT helps patients shift from struggling against tinnitus toward acceptance.

Clinical research shows that mindfulness approaches can reduce tinnitus severity, psychological distress, and negative thinking. Trials demonstrate that MBCT and Mindfulness-Based Stress Reduction (MBSR) are effective, with some studies finding MBCT more beneficial than relaxation therapies, and benefits lasting for months. Online versions of mindfulness-based tinnitus programs have also proven feasible and helpful, particularly during the COVID-19 pandemic. Ongoing studies directly comparing MBCT with CBT further highlight the expanding role of mindfulness in tinnitus care.

Mindfulness-Based Cognitive Therapy (MBCT) MBCT is an eight-week, group-based psychological program originally developed to prevent relapse in recurrent depression. It combines mindfulness meditation practices with cognitive-behavioral therapy strategies, fostering non-judgmental awareness of present-moment experience, greater cognitive flexibility, and reduced reactivity to negative thoughts and emotions.

Mechanistic research suggests that MBCT works by:

Increasing cognitive defusion - the ability to step back from and observe thoughts without automatically believing or reacting to them. Reducing experiential avoidance - the tendency to suppress or avoid difficult emotions and sensations. Enhancing self-compassion - a kinder, more understanding stance toward oneself in times of suffering.

Internet-Delivered MBCT (iMBCT) Internet-delivered psychological interventions (IPIs) have the potential to greatly expand access to evidence-based care. Online MBCT (iMBCT) can be delivered synchronously (live sessions with a facilitator) or asynchronously (self-paced, unguided), with evidence supporting effectiveness in reducing distress and improving resilience. Unguided iMBCT programs are especially promising for public health implementation due to their low delivery cost and scalability, but high-quality trials in specific clinical groups remain rare.

Study Objectives The main objective of the planned research is to evaluate the effectiveness of an iMBCT intervention for tinnitus distress, depression, and anxiety symptoms among chronic tinnitus patients.

More specific objectives are as follows: (1) evaluate the effectiveness of the intervention relative to waiting-list according to self-reported measures; (2) conduct an examination of predictors and mediators of treatment response; (3) evaluate the maintenance of tinnitus distress alleviation as well as anxiety and depression symptoms at 1-month and 6-month follow-up.

Study design and setting This study is a two-arm, parallel-group, randomized controlled trial (RCT) comparing iMBCT with a waiting list control. A CONSORT-compliant flowchart (Figure 1) depicts participant progression. The participants will be allocated to either a 6-week iMBCT intervention, or (2) waiting-list control group (WLC).

Participants will be instructed to contact the research team in the event of a crisis, at which point they will be assessed by a study-affiliated psychotherapist or psychiatrist and referred to appropriate clinical services as necessary.

All assessments will be conducted via an online data collection platform provided by the investigators (terapiawszumach.pl) at the following time points: (1) screening, (2) baseline (prior to randomization), (3) upon completion of the 6-week online program or waitlist period, (4) one month post-treatment (for participants in the active intervention groups), and (5) six months post-treatment.

Conditions

Chronic Tinnitus; Anxiety; Depressive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT)

A 6-week (42 days), unguided online adaptation of the Mindfulness-Based Cognitive Therapy (MBCT) program. The intervention consisted of six sequential modules delivered through a secure web platform, including guided mindfulness meditations, body scan, mindful movement, and cognitive-behavioral exercises. Participants received audio recordings, written materials, and reflective tasks, along with automated reminder emails. No therapist guidance was provided.

Group Type: EXPERIMENTAL

Mindfulness-Based Cognitive Therapy (Internet-delivered)

Intervention Type: BEHAVIORAL

A 6-week (42 days), unguided online adaptation of the Mindfulness-Based Cognitive Therapy (MBCT) program. The intervention consisted of six sequential modules delivered through a secure web platform, including guided mindfulness meditations, body scan, mindful movement, and cognitive-behavioral exercises. Participants received audio recordings, written materials, and reflective tasks, along with automated reminder emails. No therapist guidance was provided.

Waiting List Control

Participants in this arm received no active intervention during the 6-week waitlist period but completed all study assessments on the same schedule as intervention arms. After the waiting period, participants were offered to take part in the online MBCT program.

Group Type: PLACEBO_COMPARATOR

No intervention

Intervention Type: BEHAVIORAL

Participants in this arm received no active intervention during the 6-week waitlist period but completed all study assessments on the same schedule as intervention arms. After the waiting period, participants were offered to take part in the online MBCT program.

Interventions

Mindfulness-Based Cognitive Therapy (Internet-delivered)

A 6-week (42 days), unguided online adaptation of the Mindfulness-Based Cognitive Therapy (MBCT) program. The intervention consisted of six sequential modules delivered through a secure web platform, including guided mindfulness meditations, body scan, mindful movement, and cognitive-behavioral exercises. Participants received audio recordings, written materials, and reflective tasks, along with automated reminder emails. No therapist guidance was provided.

Intervention Type: BEHAVIORAL

No intervention

Participants in this arm received no active intervention during the 6-week waitlist period but completed all study assessments on the same schedule as intervention arms. After the waiting period, participants were offered to take part in the online MBCT program.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Willingness and ability to participate in online therapy.

2. Polish language proficiency.

3. 18 years or older.

4. Suffering from chronic tinnitus for at least 3 months.

Exclusion Criteria

1) Mentally incapable patients. 2) Patients who have already completed structured mindfulness training.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: collaborator

University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Paweł Holas

MD, PhD, associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paweł Holas, MD, PhD

Role: STUDY_DIRECTOR

University of Warsaw

Locations

Faculty of Psychology, University of Warsaw

Warsaw, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Paweł Holas, MD PhD

Role: CONTACT

pawel.holas@psych.uw.edu.pl

+48501254501

Weronika Joanna Caban, student

Role: CONTACT

wj.caban@student.uw.edu.pl

+48537651655

Facility Contacts

Paweł Holas

Role: primary

pawel.holas@psych.uw.edu.pl

501254501

Other Identifiers

8/04/2023

Identifier Type: -

Identifier Source: org_study_id