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

NCT04675112 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-12-22

No results posted yet for this study

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.

Conditions

  • Tinnitus

Interventions

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.

Sponsors & Collaborators

  • Gkouskou Kalliopi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-12-31
Completion
2022-12-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04675112 on ClinicalTrials.gov