N/A
N=126
Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT04335812 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Tinnitus Functional Index (TFI); Measure of Tinnitus Distress — 48.7; 50.52; 32.13; 28.95 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
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tinnitus Functional Index (TFI); Measure of Tinnitus Distress |
48.7; 50.52; 32.13; 28.95; 30.66; 28.95 | — |
| SECONDARY Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition |
44.67; 42.52; 30.96; 27.26; 28.93; 27.26 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9); Measure of Depression |
9.17; 9.10; 4.96; 4.32; 5.04; 4.32 | — |
| SECONDARY Generalized Anxiety Disorder (GAD-7); Measure of Anxiety |
7.75; 9.19; 5.21; 4.48; 4.86; 4.48 | — |
| SECONDARY Insomnia Severity Index (ISI); Measure of Insomnia |
11.90; 12.25; 8.93; 7.46; 8.43; 7.46 | — |
| SECONDARY EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life |
72.59; 75.43; 79.71; 78.15; 76.43; 78.15 | — |
| SECONDARY Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem |
5.79; 6.29; 3.21; 2.85; 3.36; 2.85 | — |
| SECONDARY Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem |
6.19; 5.94; 3.75; 4.59; 4.71; 4.59 | — |
| SECONDARY Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance |
1.17; 1.22; 1.0; 0.67; .96; .67 | — |
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. The purpose of this study is to evaluate if the full CBT administered via the Internet results in better outcomes when compared to relaxation only CBT administered via the Internet for adults with tinnitus in the United States.
Eligibility Criteria
Inclusion Criteria
- aged 18 years and older living in the USA;
- the ability to read and type in English;
- 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.
Data sourced from ClinicalTrials.gov (NCT04335812). 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.