Internet-delivered Psychological Interventions for Tinnitus

NCT05705323 | Completed

• 1 other identifier: TinnitusLT_1_2022
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Tinnitus can be very distressing for some individuals who experience it. The most studied intervention that works well for tinnitus distress is cognitive behavioral therapy (CBT). There is enough evidence to claim that internet-delivered guided CBT for tinnitus is as effective as CBT delivered face-to-face. The goal of this randomized controlled trial is to test the effectiveness of an internet-delivered cognitive behavioral therapy (CBT) for tinnitus and an internet-delivered mindfulness-based tinnitus stress reduction intervention by comparing them one against each other and a waiting list control group in the adult population experiencing tinnitus. The main questions this study aims to answer are:

• Feasibility of delivering interventions for tinnitus distress over the internet.
• Is any of the two interventions more effective in reducing tinnitus-related stress than the waiting list control?
• Is the effectiveness of mindfulness intervention non-inferior to CBT intervention for tinnitus?
• Is participant engagement and dropout different in mindfulness and CBT interventions? Participants will be randomly assigned to a CBT, Mindfulness, or control group and will be asked to engage with the materials prescribed to that group for eight weeks.

Conditions

Tinnitus; Distress, Emotional; Depression, Anxiety; Sleep

Keywords

CBT; Tinnitus; Mindfulness-based stress reduction; Internet-delivered; Cognitive behavioral therapy; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Change in score on Tinnitus Handicap Inventory (THI)

  The Tinnitus Handicap Inventory is designed to measure the subject's sensations caused by tinnitus and to assess the impact of tinnitus on daily life. It is also suitable for measuring the change in the severity of a murmur before and after an intervention. The THI questionnaire consists of 25 questions. The subject completes the questionnaire by ticking the most appropriate answer. The researcher scores the questionnaire as follows: 'Yes' is scored with 4 points, 'No' is scored with 0 points and 'Sometimes' is scored with 2 points. The total score is obtained by summing the number of responses to all 25 questions, multiplied by the coefficients given in the table. The higher the scale estimates, the higher the score, the more significant the disability caused by the murmur and the more significantly it affects the life of the subject. The severity scale is as follows: 0-16 mild; 18-36 moderate; 38-56 moderate; 58-76 severe; 78-100 catastrophic.

  Pre-treatment, week 8, 3 and 12 months post-treatment

Secondary Outcomes (6)

• Change in score on Patient Health Questionnaire (PHQ-9)

  Pre-treatment, week 8, 3 and 12 months post-treatment

• Change in score on Generalized Anxiety Disorder-7 (GAD-7)

  Pre-treatment, week 8, 3 and 12 months post-treatment

• Change in score on Insomnia Severity Index (ISI)

  Pre-treatment, week 8, 3 and 12 months post-treatment

• Change in score on Tinnitus and Hearing Survey (THS)

  Pre-treatment and week 8.

• Change in score on The Mindful Attention Awareness Scale (MAAS])

  Pre-treatment, week 8, 3 and 12 months post-treatment

Other Outcomes (1)

• The Big Five Inventory (BFI-10)

  Pre-treatment

Study Arms (3)

Internet-delivered cognitive behavioral therapy for tinnitus

EXPERIMENTAL

An 8-week modular cognitive behavioral therapy

Behavioral: Internet-delivered cognitive behavioral therapy (iCBT)

Internet-delivered mindfulness-based therapy for tinnitus

EXPERIMENTAL

An 8-week mindfulness-based stress reduction.

Behavioral: Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR)

Waiting-list control

NO INTERVENTION

The waiting list for 8 weeks.

Interventions

Internet-delivered cognitive behavioral therapy (iCBT) BEHAVIORAL

This CBT is specifically adapted for individuals experiencing tinnitus

Internet-delivered cognitive behavioral therapy for tinnitus

Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR) BEHAVIORAL

This is a mindfulness-based intervention specifically adapted for individuals experiencing tinnitus

Internet-delivered mindfulness-based therapy for tinnitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experience tinnitus for at least three months;
• Scores 28 or more on THI;
• Has the ability to use a computer (or smartphone or tablet) with a connection to the internet for the duration of the study;
• Comprehension and ability to write and speak in the Lithuanian language.

You may not qualify if:

• Inability to allocate sufficient time for participation in an 8-week intervention;
• Significant medical or psychiatric conditions which would prevent participation;
• Participation in other tinnitus interventions during the study.

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Vilnius University

Vilnius, Lithuania, LT-01513, Lithuania

Location

Related Publications (1)

• Eimontas J, Gegieckaite G, Asaciova I, Sticinskaite N, Arcimaviciute L, Savickaite D, Vaitiekunaite-Zubriakoviene D, Polianskis M, Gans J, Beukes E, Manchaiah V, Andersson G, Lesinskas E. Internet-delivered cognitive behavioral therapy for tinnitus compared to Internet-delivered mindfulness for tinnitus: a study protocol of a randomized controlled trial. Trials. 2023 Apr 12;24(1):269. doi: 10.1186/s13063-023-07299-9.

  PMID: 37046290 DERIVED

MeSH Terms

Conditions

Tinnitus; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonas Eimontas, PhD

  Vilnius University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 30, 2023
• Study Start: February 15, 2023
• Primary Completion: April 11, 2024
• Study Completion: May 1, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)