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

NCT07183826 | Recruiting

• 1 other identifier: 8/04/2023
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Tinnitus; Anxiety; Depressive

Keywords

chronic tinnitus; tinnitus; Mindfulness-Based Cognitive Therapy; MBCT; Internet-delivered intervention; Online mental health; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (4)

• Acceptance of Tinnitus

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

• Self-compassion

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

• cognitive and affective mindfulness

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

• Emotion Regulation

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

Study Arms (2)

Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT)

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Cognitive Therapy (Internet-delivered)

Waiting List Control

PLACEBO COMPARATOR

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.

Behavioral: No intervention

Interventions

Mindfulness-Based Cognitive Therapy (Internet-delivered) 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.

Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT)

No intervention 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.

Waiting List Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness and ability to participate in online therapy.
• Polish language proficiency.
• years or older.
• Suffering from chronic tinnitus for at least 3 months.

You may not qualify if:

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

Sponsors & Collaborators

• University of Warsaw: lead
• Medical University of Warsaw: collaborator

Study Sites (1)

Faculty of Psychology, University of Warsaw

Warsaw, 00-927, Poland

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Tinnitus; Depression

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Paweł Holas, MD, PhD

  University of Warsaw

  STUDY DIRECTOR

Central Study Contacts

Paweł Holas, MD PhD

CONTACT

+48501254501; pawel.holas@psych.uw.edu.pl

Weronika Joanna Caban, student

CONTACT

+48537651655; wj.caban@student.uw.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, associate professor

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 19, 2025
• Study Start: April 1, 2025
• Primary Completion: December 19, 2025
• Study Completion (Estimated): June 19, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

PL (1)