18 and older, any sex, with Tinnitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Tinnitus Functional Index (TFI); Measure of Tinnitus DistressPrimary· T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
Tinnitus Functional Index (TFI) is a 25-item questionnaire that evaluates the severity of tinnitus distress. Total possible score ranges from 0-to-100 with higher scores suggesting more severe tinnitus distress (i.e., worse outcome). Scores \>25 indicate tinnitus is a significant problem requiring tinnitus intervention.
Baseline
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
61.06
± 19.03
Post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
41.78
± 27.02
2-months post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
40.38
± 26.65
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus CognitionSecondary· T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
Tinnitus Cognition Questionnaire (TCQ) is a 26-item questionnaire that assesses positive and negative cognitions associated with tinnitus. The first 13 items refer to negative thoughts and the second 13 items refer to positive thoughts. Responses are marked on a five-point Likert scale (0 to 4). The negative items (1-13) are scored 0-4, whereas the positive items (14-26) are reverse-scored: 4-0. The scoring procedure involves the simple addition of the number circled by the respondent for items 1-13 and the addition of reverse-scored items 14-26. The total score of the TCQ has a potential rang
T0: Baseline
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
52.56
± 13.18
T1: Post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
38.55
± 24.57
T2: 2-month post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
37.06
± 23.53
Patient Health Questionnaire (PHQ-9); Measure of DepressionSecondary· T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire that assesses depression severity. Responses are marked on a four-point Likert scale (0 to 3). The total score can range from 0 to 27 with higher scores indicating more severe depression (i.e., worse outcome).
T0: Baseline
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
11.25
± 7.02
T1: Post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
5.41
± 5.82
T2: 2-month post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
6.13
± 8.55
Generalized Anxiety Disorder (GAD-7); Measure of AnxietySecondary· T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
Generalized Anxiety Disorder (GAD-7) is a 7-item questionnaire that assesses the severity of anxiety. Responses are marked on a four-point Likert scale (0 to 3). The total score can range from 0 to 21 with higher scores indicating more severe anxiety (i.e., worse outcome).
T0: Baseline
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
10.25
± 5.32
T1: Post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
5.23
± 4.24
T2: 2-month post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
5.62
± 5.4
Insomnia Severity Index (ISI); Measure of InsomniaSecondary· T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
Insomnia Severity Index (ISI) is a 7-item questionnaire that evaluates insomnia. Responses are marked on a five-point Likert scale (0 to 4). The total score can range from 0 to 28 with higher scores indicating more severe insomnia (i.w., worse outcome).
T0: Baseline
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
14.97
± 6.6
T1: Post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
10.55
± 7.11
T2: 2-month post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
9.38
± 7.71
EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of LifeSecondary· T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
EQ-5D-5L VAS is a single-item questionnaire that evaluates the health-related quality of life. Responses are marked on a 0-100 scale with higher scores indicating higher health-related quality o life (i.e., better outcome).
T0: Baseline
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
67.03
± 16.94
T1: Post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
73.64
± 14.65
T2: 2-month post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
76.75
± 15.33
Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus ProblemSecondary· T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problem and ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The total T
T0: Baseline
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
8.06
± 3.6
T1: Post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
4.64
± 3.75
T2: 2-months post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
4.44
± 4.35
Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing ProblemSecondary· T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problem and ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The total T
T0: Baseline
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
5.34
± 4.29
T1: Post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
5.55
± 4.06
T2: 2-months post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
3.94
± 4.40
Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound ToleranceSecondary· T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problem and ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The total T
T0: Baseline
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
1.72
± 1.28
T1: Post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
1.5
± 1.47
T2: 2-months post-intervention
Group
Value
95% CI
Internet-based Cognitive Behavior Therapy
1.13
± 1.09
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lamar University
Last refreshed: 6 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04335929.