N/A N=32 Treatment

Internet-based Cognitive Behavioural Therapy for Spanish Tinnitus Sufferers

Tinnitus

Bottom Line

View on ClinicalTrials.gov: NCT04335929 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Tinnitus Functional Index (TFI); Measure of Tinnitus Distress — 61.06; 41.78; 40.38 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Internet-based Cognitive Behavior Therapy (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lamar University
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Tinnitus Functional Index (TFI); Measure of Tinnitus Distress	61.06; 41.78; 40.38	—
SECONDARY Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition	52.56; 38.55; 37.06	—
SECONDARY Patient Health Questionnaire (PHQ-9); Measure of Depression	11.25; 5.41; 6.13	—
SECONDARY Generalized Anxiety Disorder (GAD-7); Measure of Anxiety	10.25; 5.23; 5.62	—
SECONDARY Insomnia Severity Index (ISI); Measure of Insomnia	14.97; 10.55; 9.38	—
SECONDARY EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life	67.03; 73.64; 76.75	—
SECONDARY Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem	8.06; 4.64; 4.44	—
SECONDARY Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem	5.34; 5.55; 3.94	—
SECONDARY Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance	1.72; 1.5; 1.13	—

Summary

Nearly 50 million people in the U.S. experience tinnitus, of which about 20 million people have burdensome chronic tinnitus. Tinnitus can be very debilitating as many aspects of daily life can be affected, such as sleep, mood, and concentration. Currently, there is no cure for tinnitus. Pharmacological or sound-therapy based interventions are sometimes provided but may be of limited value to certain individuals. Research suggests that Cognitive Behavior Therapy (CBT) based approaches have the most evidence of effectiveness in the management of tinnitus. However, CBT is rarely offered to tinnitus sufferers in the U.S. (less than 1%), partly because of lack of trained professionals who can deliver CBT. To improve access to CBT for tinnitus, an online CBT program has been developed which is also available in Spanish. However, the outcomes of the Spanish version of the program has not been evaluated. The purpose of the current study is to determine the feasibility of guided Spanish version of the Internet-based CBT (ICBT) using audiological support on tinnitus distress and tinnitus-related comorbidities.

Eligibility Criteria

Inclusion Criteria

aged 18 years and older adults from across the globe;
the ability to read and type in Spanish;
no barriers to using a computer (e.g. no significant fine motor control or visual problems);
Internet and e-mail access and the ability to use it;
commitment to completing the program;
completion of the online screening and outcome questionnaires;
agree to participate in either group and be randomized to one of these groups;
understand and work towards the end goal of reducing the impact and distress of tinnitus, although the strength of the tinnitus may remain the same;
be available for 12 months after starting the study to complete a 1-year follow-up questionnaire; and
experience bothersome tinnitus for a minimum period of 3 months;

Exclusion Criteria

reporting any major medical or psychiatric conditions;
reporting pulsatile, objective or unilateral tinnitus, which has not been investigated medically;
tinnitus as a consequence of a medical disorder, still under investigation; and
undergoing any other tinnitus therapy while participating in this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04335929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.