Internet-Based Mindfulness-Based Cognitive Therapy (iMBCT) for Chronic Tinnitus Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Warsaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willingness and ability to participate in online therapy.
Polish language proficiency.
18 years or older.
Suffering from chronic tinnitus for at least 3 months.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness-Based Cognitive Therapy (Internet-delivered)
BehavioralA 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 intervention
BehavioralParticipants 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.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT)Experimental treatment 1 intervention
Group B: Waiting List ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
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.
Time frame
Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)Secondary outcomes
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.
Time frame
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.
Time frame
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
Time frame
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.
Time frame
Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Warsaw
Lead sponsor
Medical University of Warsaw
Collaborator
Source ClinicalTrials.gov