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Completed

NCT Number: NCT07324603

Smartphone-Based vs Face-to-Face Counseling for Tinnitus

This study aims to compare the effectiveness of smartphone-based counseling and face-to-face counseling in adults with chronic tinnitus. Both interventions are based on the same structured counseling protocol and are delivered over a six-week period. The primary research question is whether smartphone-based counseling can achieve clinical outcomes comparable to those of traditional face-to-face counseling in reducing tinnitus-related impact and associated symptoms.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Health Sciences

Kayseri, 38000, Turkey (Türkiye)

About this study

This study is a randomized, parallel-group clinical trial designed to evaluate two counseling delivery formats for chronic tinnitus. Eligible adult participants with chronic subjective tinnitus are allocated to either smartphone-based counseling or face-to-face counseling. Both groups receive the same structured counseling content, with the delivery format being the only difference between interventions.

The counseling protocol focuses on tinnitus education, correction of maladaptive beliefs, and development of coping strategies. In the face-to-face group, counseling is delivered through scheduled in-person sessions using a structured educational booklet. In the smartphone-based group, the same content is delivered through a mobile application consisting of sequential modules, including assessment, education, coping strategies, and a clinician support feature.

Participants in both groups complete baseline assessments prior to counseling and follow-up evaluations at two and six weeks. The study is designed to examine whether smartphone-based counseling can achieve outcomes comparable to traditional face-to-face counseling when a unified counseling protocol is applied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 years or older

Diagnosis of chronic subjective tinnitus lasting at least 6 months

Completion of a comprehensive audiological evaluation

Ability to read and understand the study materials

Adequate cognitive function as determined by a Mini-Mental State Examination score of 25 or higher

Willingness and ability to provide written informed consent

Exclusion criteria

Presence of objective tinnitus

History of neurological disorders

Diagnosed major psychiatric disorders

Receipt of tinnitus-related treatment within the previous 3 months

Inability to use or access the smartphone application (for technical or device-related reasons)

Treatment and study plan

Face-to-Face Tinnitus Counseling

Behavioral

Structured tinnitus counseling is delivered in person using a standardized educational booklet over a six-week period.

Smartphone-Based Tinnitus Counseling

Behavioral

Structured tinnitus counseling is delivered via a mobile application with sequential modules over a six-week period

Primary outcomes

  1. Tinnitus Impact

    Time frame: Baseline to 6 weeks

    Change in tinnitus impact assessed using the Tinnitus Handicap Inventory (THI).

Secondary outcomes

  1. Depressive Symptoms

    Time frame: Baseline to 6 weeks

    Change in depressive symptoms assessed using the Beck Depression Inventory (BDI).

  2. Sleep Quality

    Time frame: Baseline to 6 weeks

    Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).

  3. Perceived Tinnitus Severity

    Time frame: Baseline to 6 weeks

    Change in perceived tinnitus severity assessed using a Visual Analog Scale (VAS).

  4. Tinnitus-Related Annoyance

    Time frame: Baseline to 6 weeks

    Change in tinnitus-related annoyance assessed using a Visual Analog Scale (VAS).

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

A Randomized Controlled Trial Comparing Smartphone-Based and Face-to-Face Counseling for Chronic Tinnitus

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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