Internet-delivered Psychological Interventions for Tinnitus (TinnitusLT)

Vilnius University

Status: Completed

Conditions: Depression, Anxiety; Tinnitus; Sleep; Distress, Emotional

Treatments: Behavioral: Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR); Behavioral: Internet-delivered cognitive behavioral therapy (iCBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05705323

TinnitusLT_1_2022

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 3 patient groups

Internet-delivered cognitive behavioral therapy for tinnitus

Experimental group

Description:

An 8-week modular cognitive behavioral therapy

Treatment:

Behavioral: Internet-delivered cognitive behavioral therapy (iCBT)

Internet-delivered mindfulness-based therapy for tinnitus

Experimental group

Description:

An 8-week mindfulness-based stress reduction.

Treatment:

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

Waiting-list control

No Intervention group

Description:

The waiting list for 8 weeks.