Somatic Tracking for Tinnitus
ConditionTinnitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College London Hospitals
About this trial
We are examining the effect of mindfulness meditation on attitudes towards tinnitus, as well as physical and psychological distress associated with the condition. The meditation is designed to promote neuroplasticity, fostering new neural connections to help you reinterpret tinnitus through a lens of safety and reduce the perception of threat. This approach integrates several techniques from various psychological therapies which have been promising in reducing tinnitusrelated distress. Therefore, the purpose of this study is to see whether a guided mindfulness meditation intervention is effective in improving the acceptance of tinnitus symptoms, as well as reducing tinnitus-related distress in people living with tinnitus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Experiencing distressing tinnitus
Sufficient English language and hearing ability to take part
Completed all relevant medical and audiological investigations and concluded ensuing treatment for any underlying disease
Not be engaging in any other therapy for tinnitus.
Disqualifiers
Risk to self (scoring 'nearly every day' on PHQ-9 question "Thoughts that you would be better off dead, or of hurting yourself in some way?")
Severe mental health difficulties (PHQ-9 score of 20 or more)
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness Meditation
Other interventionSomatic tracking is one aspect of most mindfulness meditation protocols, involving paying attention to the present non-judgementally, and focusing on breath and bodily sensations (e.g., sounds in the case tinnitus). This study employs this approach as a standalone intervention, in the form of a guided meditation recording.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Cognitions about Tinnitus
Positive and negative thoughts about tinnitus will be assessed with the Tinnitus Cognitions Questionnaire (TCQ) (Wilson \& Henry 1998). It consists of 26 items (statements) rated on a 5-point Likert scale. For example, "if only the noise would go away." The first 13 items refer to negative thoughts and the second 13 items refer to positive thoughts. The TCQ has been supported as a valid measure of positive and negative thinking in tinnitus (Handscomb et al., 2017), demonstrates good reliability, and is suitable for research use
Time frame
Baseline and 2 weeks2
Psychological Distress
Depression will be assessed on the Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 1999), with nine items, such as "Feeling down, depressed, or hopeless?". Anxiety will be assessed on the Generalised Anxiety Disorder Assessment-7 (GAD-7) (Spitzer et al., 2006), with seven items, for example "Feeling afraid as if something awful might happen". Both the PHQ-9 and GAD-7 have been shown to be valid and reliable in assessing depressive and anxious symptoms respectively.
Time frame
Baseline and 2 weeks3
Tinnitus Severity
Tinnitus severity will be assessed using the Tinnitus Functional Index (TFI) (Meikle et al., 2012). It consists of 25 items covering overall tinnitus severity and negative impact. The TFI has demonstrated sensitivity to treatment-related change, high validity, and good reliability. The measure has been concluded to be suitable for both clinical and research purposes.
Time frame
Baseline and 2 weeks4
Tinnitus Annoyance Rating
Participants answer the question, 'Right now, how annoying is your tinnitus?" using ratings on a scale from 1 (not at all) to 10 (much more). Each session of the TT intervention involves the guided meditation session, followed by the tinnitus annoyance rating.
Time frame
Baseline and daily over 2 weeksSecondary outcomes
1
Post-Study Feedback
Data from the post-study feedback survey, regarding satisfaction with and acceptability of the intervention and study.
Time frame
At the end of the study (2 weeks)Sponsors and contacts
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Source ClinicalTrials.gov