Somatic Tracking for Tinnitus

NCT06895824 | Recruiting

• 1 other identifier: 21415/001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

tinnitus; mindfulness; mindfulness meditation; somatic tracking; tinnitus distress

Outcome Measures

Primary Outcomes (4)

• 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

  Baseline and 2 weeks

• 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.

  Baseline and 2 weeks

• 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.

  Baseline and 2 weeks

• 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.

  Baseline and daily over 2 weeks

Secondary Outcomes (1)

• Post-Study Feedback

  At the end of the study (2 weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group participants will be given the choice to proceed to the Tinnitus Tracking \[TT\] intervention, a 15-minute somatic tracking guided meditation recorded by Dr Florian Vogt, a tinnitus treatment specialist, immediately or the next day. Before starting the first session of the TT intervention, 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. Participants will be reminded to complete one session daily over a period of two weeks and will only be allowed to access the experiment once a day. Reminders will be sent daily via email by Gorilla, once access to the intervention for the day has been provided.

Other: Mindfulness Meditation

Control

NO INTERVENTION

Participants in this arm do not have tasks to complete over the two-week study period. A wait-list control condition will be set-up for this group, whereby participants will receive the intervention after completing the follow-up measures in two weeks. Since our sample is non-clinical and less at risk, we believe the two week delay period should not cause distress or adverse events.

Interventions

Mindfulness Meditation OTHER

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.

Also known as: Somatic Tracking

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (1)

Online

London, NW1 9UT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Tinnitus

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Florian Vogt

CONTACT

00442034565651; florian.vogt@nhs.net

Shyn Wei Phua

CONTACT

shyn.phua.21@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Clinical Psychologist, Head of Department of Clinical Psychology, Audiovestibular Medicine

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: December 11, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Research documents/data will be kept on UCL's RDSS for one year. At the end of the one-year period, the data will be automatically deleted.

Locations

GB (1)