Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus

Not Applicable

• Conditions: Tinnitus
• Interventions: Behavioral: Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)

• Registration Number: NCT04675112
• Lead Sponsor: Gkouskou Kalliopi

Brief Summary

Psychological and behavioral interventions, such as Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT), are commonly applied either alone or in combination for the management of tinnitus but selection of the intervention model remains arbitrary. Our purpose is to evaluate the hypothesis that genetic markers may guide the choice of tinnitus treatment towards improved therapeutic outcomes. Patients with subjective idiopathic tinnitus are assigned to either a genetically-informed CBT or TRT intervention protocol based on the status of four single nucleotide polymorphisms (SNPs) of the dopamine and serotonin pathways, namely COMT rs4680, HTR2A rs7997012, HTR2A rs6311, and TPH2 rs4570625, that have been associated with behavioral or cognitive responses (Group A), or to a conventional approach (Group B) in which the choice of treatment was not directed by genotypic data. Tinnitus Handicap Index (THI) scores of perceived tinnitus severity are recorded at the initial and at the fourth session of treatment using appropriate questionnaires.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Last Update Submitted: 2020-12-19
• Last Update Posted: 2020-12-22
• Primary Completion: 2020-12-31
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• adult patients with bothersome bilateral non-pulsative tinnitus and hearing loss

Exclusion Criteria

• no major comorbidities
• no psychiatric history

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group A genetically informed intervention	Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)	Group A patients are offered a genetically based approach to tinnitus management that includes a genetic test and at least three office based treatment sessions. A rationally-designed personalized management plan based on the genetic results is based on four single nucleotide polymorphisms (SNPs) of the dopamine and serotonin pathways, namely COMT rs4680, HTR2A rs7997012, HTR2A rs6311, and TPH2 rs4570625, that have been associated with behavioral or cognitive responses
group B control	Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)	In Group B, treatments are offered randomly taking care to offer CBT to equal number of patients as in Group A. In both groups, during the first visit, patients are offered a simple, few-minute tinnitus update and advice, relevant to their educational level and are being suggested that an average of 4 sessions are required over a period of approx. 4 months for making tinnitus noise less or not bothersome

Primary Outcome Measures

Name	Time	Method
Tinnitus Handicap Inventory (THI)	4 months	Upon a detailed history and an integrated ENT and audiological examination, the patients are asked to answer the THI twice (pre and post treatment), a questionnaire that quantifies the impact of tinnitus on everyday function. It is psychometrically robust and demonstrates adequate reliability and validity \[9\]

Trial Locations

Locations (1)

ENT clinic; 🇬🇷 Athens, Greece