AzTrials
AzTrials

Chronic TinnitusNCT07183826

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

A study testing Mindfulness-Based Cognitive Therapy (Internet-delivered) in people with Chronic Tinnitus and Anxiety, run by University of Warsaw at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Tinnitus, Anxiety, Depressive
What is being tested?
Mindfulness-Based Cognitive Therapy (Internet-delivered)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 sitePoland
Study dates
1 Apr 2025to 19 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 ≥32 on the TFI. Exclusion criteria
  • 1) Mentally incapable patients. 2) Patients who have already completed structured mindfulness training.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Paweł Holas, MD PhD contact

+48501254501

pawel.holas@psych.uw.edu.pl

Weronika Joanna Caban, student contact

+48537651655

wj.caban@student.uw.edu.pl

Poland1 site, 1 recruiting
  • Faculty of Psychology, University of Warsaw

    Warsaw, 00-927

    Paweł Holas, 501254501, pawel.holas@psych.uw.edu.pl

    Recruiting

Other trials in Poland

About this study

Official title: Internet-Based Mindfulness-Based Cognitive Therapy (iMBCT) for Chronic Tinnitus Patients: a Randomized Controlled Trial Protocol

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.

Read the 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.

Being tested
Mindfulness-Based Cognitive Therapy (Internet-delivered), No intervention
Keywords
chronic tinnitus, tinnitus, Mindfulness-Based Cognitive Therapy, MBCT, Internet-delivered intervention, Online mental health, Depression, Anxiety
Medical subject headings
Anxiety Disorders, Tinnitus, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-Based Cognitive Therapy (Internet-delivered)Behavioural

    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.

  • No interventionBehavioural

    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.

Study groups in NCT07183826
Study groupRoleWhat they receive
Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT)ExperimentalA 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.
Receives: Behavioral: Mindfulness-Based Cognitive Therapy (Internet-delivered)
Waiting List ControlPlacebo comparatorParticipants 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.
Receives: Behavioral: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Tinnitus Distress

    Change in Tinnitus Distress from baseline to post-intervention, and follow-up, measured by TFI is a 25-item instrument designed to assess the impact of tinnitus on various aspects of daily functioning, using 11-point Likert scales. Total scores range from 0 to 100, with a minimum clinically important difference (MCID) of 13 points and higher scores indicating greater distress.

    Measured: Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)

  2. Anxiety and Depression symptoms

    Instrument: Hospital Anxiety and Depression Scale (HADS), a 14-item self-report instrument designed to assess symptoms of anxiety and depression, with each item rated on a four-point scale. It consists of two sub-scales: HADS-anxiety and HADS-depression, 7 items each. The two-factor structure has been verified. Each sub-scale yields a score ranging from 0 to 21, with higher values indicating more symptoms.

    Measured: Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)

Secondary outcomes (4)
  1. Acceptance of Tinnitus

    Instrument: Tinnitus Acceptance Questionnaire (TAQ), a 12-item questionnaire developed specifically for measuring acceptance in patients with CT. Each item is evaluated on a scale from 0 (never true) to 6 (always true), and their scores are combined to determine a total score, with a maximum of 72 points. Higher scores indicate higher levels of acceptance.

    Measured: Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)

  2. Self-compassion

    Instrument: the Self-Compassion Scale-Short Form (SCS-SF), a 12-item questionnaire developed to assess the capacity for self-compassion. It comprises two sub-scales: self-disparagement and self-care, each consisting of six items. Overall score fall in range 1 to 5 and are the mean value of 12 items after reverse scoring negatively worded items. Higher total scores reflect greater self-compassion, characterized by elevated self-care and reduced self-disparagement.

    Measured: Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)

  3. cognitive and affective mindfulness

    Instrument: Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), a 12-item scale that gauges everyday mindfulness by centering on how respondents encounter their thoughts and emotions. Each item is evaluated on a 4-point Likert scale, ranging from 1 (rarely/not at all) to 4 (almost always). Higher scores indicate heightened levels of mindfulness

    Measured: Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)

  4. Emotion Regulation

    Instrument: The Difficulties in Emotion Regulation Scale (DERS-16), a 16-item assessment tool designed to evaluate difficulties in emotion regulation. Respondents rate items using a 5-point Likert scale, where higher scores indicate greater difficulties in emotion regulation.

    Measured: Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start1 Apr 2025
  3. Primary completion19 Dec 2025 (estimated)
  4. Study completion19 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study used a two-arm, parallel-group randomized controlled trial design. Participants meeting inclusion criteria were randomly assigned to one of two conditions: (1) unguided internet-delivered Mindfulness-Based Cognitive Therapy (iMBCT), or (2) a waitlist control (WLC). Randomization was stratified by demographic characteristics and baseline symptom severity to ensure balanced groups.
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07183826
Sponsor's protocol ID
8/04/2023
Status last verified
Sep 2025
First submitted
12 Sep 2025
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Cognitive Therapy (Internet-delivered) in people with Chronic Tinnitus and Anxiety, run by University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paweł Holas, MD PhD (+48501254501, pawel.holas@psych.uw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tinnitus Distress (time frame: Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in