Digital thErapy For Improved tiNnitus carE Study (DEFINE)

Registry ID
ISRCTN99577932
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
Oto Health Ltd
Enrollment
196
Start date
2023-06-28
Completion date
2024-12-04
Last update
2026-08-17

Conditions

Summary

Tinnitus

Detailed description

Participants will be randomised using the ‘Sealed Envelope’ randomisation service to one of two arms, intervention or control. Intervention Group The Oto Tinnitus Programme is a digital therapeutic combining CBT with mindfulness, patient education and physical therapy (physical stretches/exercises). Oto’s programme offers a series of daily therapy sessions, where the user listens to recorded audio content that takes them through education, cognitive exercise or a tinnitus-specific meditation, and optional 1-1 chat support. Users work their way through progressive modules using a spiral curriculum, where the sessions build on techniques and exercises learned in previous sessions. The programme lasts approximately 6 weeks, using the app 4-5 times per week, which evidence suggests is sufficient time for a therapeutic difference. Users can personalise their therapy by listening to additional modules and sounds from the sound library. Participants are expected to have completed the intervention in approximately 6 weeks. Control Group Those allocated to the control arm of the study will undertake one-to-one tinnitus therapy from a trained Audiologist/Hearing Therapist/Psychologist via video calls. This is not a direct mirror of NHS practice as patients will have rapid access to therapy, rather than typical long waiting times from GP referral. Participants in the control group will agree to not use Oto or an alternative tinnitus app for the duration of the study. This control intervention will consist of a minimum of one tinnitus therapy session, with further sessions at the discretion of the participant and therapist up to a maximum of six. Therapy will begin within 1 week of randomisation. There will be a panel of therapists selected to deliver the therapy. The therapy will include several elements of current standard care formulated into a personal management plan: 1. Assessment of participant needs 2. Participant education 3. CBT 4. Relaxation therapy 5. Signposti

Interventions

Inclusion criteria

1. Aged 18 years or over 2. Experienced tinnitus symptoms for at least 3 months and self-assessed as having a significant impact on quality of life 3. Have access to a smartphone 4. Able and willing to give consent for the study prior to participation 5. Able to speak and read English to a sufficient level

Exclusion criteria

1. Tinnitus with potential “red flag” symptoms i.e. unilateral or pulsatile tinnitus (assessed via a red flag checklist during the screening call) 2. Significant mental health problems e.g. history of suicidal ideation or requirement for psychiatric/psychological support beyond primary care level 3. Have required hospitalisation for depression or taking antipsychotic drug 4. Currently taking part in another clinical trial for hearing/tinnitus 5. Awaiting surgical intervention for hearing/tinnitus 6. Previously undergone tinnitus therapy of any type e.g. CBT or TRT 7. Pregnant and breastfeeding women

Locations

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