Internet-delivered Psychological Interventions for Tinnitus

NCT ID: NCT05705323

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2024-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-delivered cognitive behavioral therapy for tinnitus

An 8-week modular cognitive behavioral therapy

Group Type: EXPERIMENTAL

Internet-delivered cognitive behavioral therapy (iCBT)

Intervention Type: BEHAVIORAL

This CBT is specifically adapted for individuals experiencing tinnitus

Internet-delivered mindfulness-based therapy for tinnitus

An 8-week mindfulness-based stress reduction.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Waiting-list control

The waiting list for 8 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internet-delivered cognitive behavioral therapy (iCBT)

This CBT is specifically adapted for individuals experiencing tinnitus

Intervention Type: BEHAVIORAL

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

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Jonas Eimontas

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonas Eimontas, PhD

Role: PRINCIPAL_INVESTIGATOR

Vilnius University

Locations

Vilnius University

Vilnius, Lithuania, Lithuania

Countries

Lithuania

References

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.

Reference Type: DERIVED

PMID: 37046290 (View on PubMed)

Other Identifiers

TinnitusLT_1_2022

Identifier Type: -

Identifier Source: org_study_id