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

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.

Study Overview

• Status: Unknown
• Conditions: Tinnitus
• Intervention / Treatment: Behavioral: Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • ENT Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no major comorbidities
• no psychiatric history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A genetically informed intervention; 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	Behavioral: Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT); CBT is a psychologically informed treatment. Depending on individual patient needs, relevant areas of tinnitus education and management/self-management strategies, such as managing the emotional consequences of tinnitus, rapid relaxation, managing fear and avoidance behaviors and changing unhelpful thoughts and beliefs, are applied in accordance to a published manual [10]. TRT is based on the neurophysiological model focusing more on education and sound therapy than on analytical cognitive and behavioral interventions. A TRT program is usually included in a management scheme with hearing aids.
Other: group B control; 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	Behavioral: Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT); CBT is a psychologically informed treatment. Depending on individual patient needs, relevant areas of tinnitus education and management/self-management strategies, such as managing the emotional consequences of tinnitus, rapid relaxation, managing fear and avoidance behaviors and changing unhelpful thoughts and beliefs, are applied in accordance to a published manual [10]. TRT is based on the neurophysiological model focusing more on education and sound therapy than on analytical cognitive and behavioral interventions. A TRT program is usually included in a management scheme with hearing aids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus Handicap Inventory (THI)	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]	4 months

Collaborators and Investigators

• Sponsor: Gkouskou Kalliopi

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: No 208/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No