Efficacy and Safety of LLM-Based CBT for Tinnitus

NCT07097909 | Completed DMC

• 1 other identifier: LLM-TCBT
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Given the limited evidence on digital cognitive behavioral therapy (CBT) for chronic subjective tinnitus, particularly interventions supported by large language models (LLMs), this two-arm, 30-day randomized controlled trial will aim to evaluate the efficacy, safety, and usability of an LLM-based conversational CBT intervention compared with a digital education control. Participants with chronic subjective tinnitus will be randomly assigned to either the intervention group, which will receive daily AI-supported CBT sessions through the Fudan Tinnitus Doctor (FTD) system, or the control group, which will receive static tinnitus education materials matched for duration and platform interface. The FTD system will be powered by a multi-agent large language model and will deliver personalized CBT-style dialogues, including psychoeducation, cognitive restructuring, relaxation, and mindfulness guidance. Outcomes will include tinnitus severity, sleep quality, mood symptoms, global improvement, and user adherence and experience.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Tinnitus Handicap Inventory (THI)

  The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

  Baseline, Day 14, and Day 30

Secondary Outcomes (4)

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline, Day 14, and Day 30

• Generalized Anxiety Disorder Scale (GAD-2)

  Baseline, Day 14, and Day 30

• Patient Health Questionnaire-2 (PHQ-2)

  Baseline, Day 14, and Day 30

• Patient Global Impression of Change (PGIC)

  Day 14, and Day 30

Other Outcomes (3)

• System Usability Scale (SUS)

  Day 30

• Net Promoter Score (NPS)

  Day 30

• User Engagement Metrics

  Continuous during 30-day intervention period

Study Arms (2)

LLM-based Conversational CBT (FTD)

EXPERIMENTAL

Participants in this group will receive a 30-day self-directed intervention delivered through the Fudan Tinnitus Doctor (FTD) system, a multi-agent large language model-based conversational AI platform designed to provide tinnitus-focused cognitive behavioural therapy.

Other: Fudan Tinnitus Doctor (FTD) Conversational AI System

Digital Education Control Group

ACTIVE COMPARATOR

Participants in this group will receive static, evidence-based tinnitus education materials presented through the same digital platform, matched in format and duration to the intervention group but without interactive AI components.

Other: Digital Education Materials

Interventions

Fudan Tinnitus Doctor (FTD) Conversational AI System OTHER

The FTD system will deliver personalized CBT-style dialogues including tinnitus psychoeducation, cognitive restructuring, relaxation training, sleep hygiene, and mindfulness guidance. The system will operate through a secure hospital web platform, accessible via personal devices, and will incorporate retrieval-augmented generation and safety moderation to ensure evidence-based and safe interaction.

LLM-based Conversational CBT (FTD)

Digital Education Materials OTHER

Educational modules will include information on tinnitus mechanisms, common coping strategies, and general lifestyle recommendations. The materials will be accessed via the same secure platform as the intervention group to control for exposure time and digital interface effects.

Digital Education Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of subjective tinnitus confirmed by a qualified investigator.
• Tinnitus duration ≥ 3 month prior to screening.
• THI score of ≥ 18
• Aged between 18 and 70 years
• The ability to use a smartphone: Both groups will receive therapeutic support and disease management primarily through a mobile application or web-based platform. This requires functional ability to operate the provided software and willingness to engage with the digital intervention protocol.
• Perceptibility: Tinnitus is present and recognizable by the participant under ordinary daily conditions (not only in quiet environments).
• Compliance and consent: Participant is assessed by the Investigator as able to understand study procedures, voluntarily agrees to participate, is willing to comply with all trial-related requirements, and provides signed informed consent prior to performance of any protocol-specified procedure.

You may not qualify if:

• Acute-phase tinnitus (duration \< 3 month or tinnitus secondary to acute otologic events).
• Pulsatile or objective tinnitus.
• Unstable symptoms: Fluctuating tinnitus loudness at screening or baseline.
• Psychiatric contraindication: History or current presence of severe psychiatric disorders (e.g., major depressive disorder with recent suicidality, schizophrenia) that, in the opinion of the Investigator, may interfere with study participation or data validity.
• Testing limitations: Inability to adequately complete tinnitus testing procedures or comply with study assessments.
• Prior therapy exposure: Previous history of sound therapy specifically for tinnitus management.
• Concurrent treatments: Ongoing psychotherapy for conditions such as anxiety or depression, or any other psychological treatment that may interfere with the study endpoints.
• Concurrent trial participation: Active participation in another interventional research study that, in the opinion of the Investigator, could affect tinnitus symptoms or interact with study procedures.
• Investigator judgment: Any condition (medical, surgical, psychiatric, or social) or factor which, in the Investigator's judgment, renders the subject unsuitable for participation, places the patient at higher risk, or may interfere with compliance or scientific validity of the trial.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shan Sun, Ph.D

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 1, 2025
• Study Start: August 2, 2025
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)