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

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

Study Overview

• Status: Completed
• Conditions: Chronic Tinnitus
• Intervention / Treatment: Behavioral: Face-to-Face Tinnitus Counseling; Behavioral: Smartphone-Based Tinnitus Counseling

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kayseri
    • Kayseri, Kayseri, Turkey (Türkiye), 38000
      • Erciyes University Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Face-to-Face Counseling; Participants receive structured tinnitus counseling delivered in person using a standardized educational booklet over a six-week period.	Behavioral: Face-to-Face Tinnitus Counseling; Structured tinnitus counseling is delivered in person using a standardized educational booklet over a six-week period.
Experimental: Smartphone-Based Counseling; Participants receive the same structured tinnitus counseling delivered via a mobile application with sequential modules over a six-week period.	Behavioral: Smartphone-Based Tinnitus Counseling; Structured tinnitus counseling is delivered via a mobile application with sequential modules over a six-week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus Impact	Change in tinnitus impact assessed using the Tinnitus Handicap Inventory (THI).	Baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Change in depressive symptoms assessed using the Beck Depression Inventory (BDI).	Baseline to 6 weeks
Sleep Quality	Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).	Baseline to 6 weeks
Perceived Tinnitus Severity	Change in perceived tinnitus severity assessed using a Visual Analog Scale (VAS).	Baseline to 6 weeks
Tinnitus-Related Annoyance	Change in tinnitus-related annoyance assessed using a Visual Analog Scale (VAS).	Baseline to 6 weeks

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Collaborators: The Scientific and Technological Research Council of Turkey

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Counseling; Digital Health; Mobile Application; Patient Education; Chronic tinnitus; Smartphone-based counseling
• Other Study ID Numbers: İ04-201-23; 124S118 (Other Grant/Funding Number: TUBITAK)

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