Clinical trial NCT05705323: Internet-delivered Psychological Interventions for Tinnitus
Official title: Internet-delivered Cognitive Behavioral Therapy for Tinnitus Compared to an Internet-delivered Mindfulness Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Distress, Emotional
Depression, Anxiety
Sleep
Keywords: CBT
Tinnitus
Mindfulness-based stress reduction
Internet-delivered
Cognitive behavioral therapy
Mindfulness
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in score on Tinnitus Handicap Inventory (THI)
timeFrame: Pre-treatment, week 8, 3 and 12 months post-treatment
Secondary outcomes:
measure: Change in score on Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-treatment, week 8, 3 and 12 months post-treatment
measure: Change in score on Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Pre-treatment, week 8, 3 and 12 months post-treatment
measure: Change in score on Insomnia Severity Index (ISI)
timeFrame: Pre-treatment, week 8, 3 and 12 months post-treatment
measure: Change in score on Tinnitus and Hearing Survey (THS)
timeFrame: Pre-treatment and week 8.
measure: Change in score on The Mindful Attention Awareness Scale (MAAS])
timeFrame: Pre-treatment, week 8, 3 and 12 months post-treatment
measure: Change in score on Tinnitus Cognitions Questionnaire (TCQ)
timeFrame: Pre-treatment, week 8, 3 and 12 months post-treatment
Other outcomes:
measure: The Big Five Inventory (BFI-10)
timeFrame: Pre-treatment
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University
Study officials:
affiliation: Vilnius University
name: Jonas Eimontas, PhD
role: PRINCIPAL_INVESTIGATOR
References: