Clinical trial NCT06895824: Somatic Tracking for Tinnitus
Official title: Can Somatic Tracking Help People Living with Tinnitus?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
mindfulness
mindfulness meditation
somatic tracking
tinnitus distress
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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?

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)

Primary outcomes:
measure: Cognitions about Tinnitus
timeFrame: Baseline and 2 weeks
measure: Psychological Distress
timeFrame: Baseline and 2 weeks
measure: Tinnitus Severity
timeFrame: Baseline and 2 weeks
measure: Tinnitus Annoyance Rating
timeFrame: Baseline and daily over 2 weeks
Secondary outcomes:
measure: Post-Study Feedback
timeFrame: At the end of the study (2 weeks)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Online
Study officials:
References: