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Recruiting NCT06895824

Somatic Tracking for Tinnitus

No phase Interventional Tinnitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness Meditation.
Who it may be relevant to
Registry conditions: Tinnitus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Can Somatic Tracking Help People Living with Tinnitus?

Overview

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.

Detailed description

Somatic 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). By encouraging individuals to observe and reinterpret distressing symptoms as benign, it aims to decrease the brain's reactivity and vigilance towards tinnitus symptoms, promoting acceptance instead of maladaptive avoidance behaviours that can inadvertently heighten awareness of symptoms (McKenna et al., 2020). Reduced tinnitus-related fear has appeared to improve CBT treatment effects (Cima et al., 2018), while greater tinnitus acceptance is associated with reduced tinnitus distress and improved mental well-being (Westin et al., 2008). This coping strategy has also reduced distress in other conditions, such as traumatic brain injury (Garland et al., 2009). In line with the greater goals of mindfulness, somatic tracking encourages sustained and flexible attention to the wider experience and environment, moving away from narrowed attention to tinnitus symptoms. In redeploying attention beyond tinnitus, awareness extends to other stimuli, and tinnitus-related distress should reduce alongside decreased resistance and selective attention which contribute to the perception of tinnitus (Marks et al., 2020b). This study aims to explore the effectiveness of a somatic tracking intervention - Tinnitus Tracking, for tinnitus sufferers. This intervention constitutes a mindfulness activity commonly part of meditation/mindfulness programmes, which will be tested as a standalone intervention. We aim to answer: What is the effect of Tinnitus Tracking compared to no intervention on (1) participants' positive and negative thoughts towards their tinnitus and (2) the physical and psychological distress associated with the condition?

Interventions

  • Other Mindfulness Meditation
    Somatic 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.

Primary outcome measures

  • Cognitions about Tinnitus [Time frame: Baseline and 2 weeks]
  • Psychological Distress [Time frame: Baseline and 2 weeks]
  • Tinnitus Severity [Time frame: Baseline and 2 weeks]
  • Tinnitus Annoyance Rating [Time frame: Baseline and daily over 2 weeks]
Secondary outcome measures (1)
  • Post-Study Feedback [Time frame: At the end of the study (2 weeks)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United Kingdom · 1 center
  • Online — London

Identifiers

NCT: NCT06895824 · 21415/001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗