NCT04335812: ICBT

Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers

Completed NA Results posted Last updated 16 July 2021

What this trial tests

NA trial testing Internet-based Cognitive Behavior Therapy in Tinnitus in 135 participants. Completed in 24 July 2020.

Timeline

4 May 2020

Primary endpoint
24 July 2020

24 July 2020

Quick facts

Lead sponsor	Lamar University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	135
Start date	4 May 2020
Primary completion	24 July 2020
Estimated completion	24 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Internet-based Cognitive Behavior Therapy

Conditions studied

• Tinnitus — all drugs for Tinnitus →

Sponsor

Lamar University

Who can join

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 Distress Primary · T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

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.

T0: Baseline

Group	Value	95% CI
R-ICBT	48.7	± 25.51
F-ICBT	50.52	± 26.65

T1: Post-intervention 1

Group	Value	95% CI
R-ICBT	32.13	± 21.38
F-ICBT	28.95	± 20.75

T2: Post-intervention 2 (both completed full ICBT)

Group	Value	95% CI
R-ICBT	30.66	± 23.45
F-ICBT	28.95	± 20.75

T3: 2-month post-intervention

Group	Value	95% CI
R-ICBT	23.81	± 9.87
F-ICBT	27.16	± 20.78

Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition Secondary · T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

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
R-ICBT	44.67	± 20.43
F-ICBT	42.52	± 18.58

T1: Post-intervention 1

Group	Value	95% CI
R-ICBT	30.96	± 20.03
F-ICBT	27.26	± 20.17

T2: Post-intervention 2 (both completed full ICBT)

Group	Value	95% CI
R-ICBT	28.93	± 17.81
F-ICBT	27.26	± 20.17

T3: 2-month post-intervention

Group	Value	95% CI
R-ICBT	25.30	± 15.84
F-ICBT	23.07	± 17.54

Patient Health Questionnaire (PHQ-9); Measure of Depression Secondary · T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

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
R-ICBT	9.17	± 7.12
F-ICBT	9.10	± 7.14

T1: Post-intervention 1

Group	Value	95% CI
R-ICBT	4.96	± 5.07
F-ICBT	4.32	± 3.95

T2: Post-intervention 2 (both completed full ICBT)

Group	Value	95% CI
R-ICBT	5.04	± 5.7
F-ICBT	4.32	± 3.95

T3: 2-month post-intervention

Group	Value	95% CI
R-ICBT	3.35	± 4.17
F-ICBT	4.12	± 4.4

Generalized Anxiety Disorder (GAD-7); Measure of Anxiety Secondary · T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

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
R-ICBT	7.75	± 6.77
F-ICBT	9.19	± 6.39

T1: Post-intervention 1

Group	Value	95% CI
R-ICBT	5.21	± 5.62
F-ICBT	4.48	± 4.17

T2: Post-intervention 2 (both completed full ICBT)

Group	Value	95% CI
R-ICBT	4.86	± 5.84
F-ICBT	4.48	± 4.17

T3: 2-month post-intervention

Group	Value	95% CI
R-ICBT	3.70	± 3.88
F-ICBT	4.68	± 4.75

Insomnia Severity Index (ISI); Measure of Insomnia Secondary · T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

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
R-ICBT	11.90	± 7.45
F-ICBT	12.25	± 7.7

T1: Post-intervention 1

Group	Value	95% CI
R-ICBT	8.93	± 6.5
F-ICBT	7.46	± 5.8

T2: Post-intervention 2 (both completed full ICBT)

Group	Value	95% CI
R-ICBT	8.43	± 5.93
F-ICBT	7.46	± 5.8

T3: 2-month post-intervention

Group	Value	95% CI
R-ICBT	7.13	± 5
F-ICBT	6.33	± 6.08

EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life Secondary · T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

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
R-ICBT	72.59	± 17
F-ICBT	75.43	± 15.92

T1: Post-intervention 1

Group	Value	95% CI
R-ICBT	79.71	± 12.14
F-ICBT	78.15	± 17.51

T2: Post-intervention 2 (both completed full ICBT)

Group	Value	95% CI
R-ICBT	76.43	± 15.79
F-ICBT	78.15	± 17.51

T3: 2-month post-intervention

Group	Value	95% CI
R-ICBT	78.22	± 11.29
F-ICBT	85.87	± 6.91

Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem Secondary · T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

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
R-ICBT	5.79	± 4.55
F-ICBT	6.29	± 5.70

T1: Post-intervention 1

Group	Value	95% CI
R-ICBT	3.21	± 3.32
F-ICBT	2.85	± 2.66

T2: Post-intervention 2 (both completed full ICBT)

Group	Value	95% CI
R-ICBT	3.36	± 3.68
F-ICBT	2.85	± 2.66

T3: 2-month post-intervention

Group	Value	95% CI
R-ICBT	2.78	± 3.19
F-ICBT	2.07	± 2.12

Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem Secondary · T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

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
R-ICBT	6.19	± 4.84
F-ICBT	5.94	± 5.06

T1: Post-intervention 1

Group	Value	95% CI
R-ICBT	3.75	± 3.7
F-ICBT	4.59	± 4.01

T2: Post-intervention 2 (both completed full ICBT)

Group	Value	95% CI
R-ICBT	4.71	± 4.32
F-ICBT	4.59	± 4.01

T3: 2-month post-intervention

Group	Value	95% CI
R-ICBT	4.65	± 3.59
F-ICBT	3.13	± 2.36

Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance Secondary · T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

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
R-ICBT	1.17	± 1.4
F-ICBT	1.22	± 1.3

T1: Post-intervention 1

Group	Value	95% CI
R-ICBT	1.0	± 1.39
F-ICBT	0.67	± 1.07

T2: Post-intervention 2 (both completed full ICBT)

Group	Value	95% CI
R-ICBT	.96	± 1.3
F-ICBT	.67	± 1.07

T3: 2-month post-intervention

Group	Value	95% CI
R-ICBT	0.91	± 1.08
F-ICBT	0.47	± 0.74

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. 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dismantling internet-based cognitive behavioral therapy for tinnitus. The contribution of applied relaxation: A randomized controlled trial.
   Beukes EW, Andersson G, Fagelson MA, Manchaiah V. · · 2021 · cited 27× · PMID 34040997 · DOI 10.1016/j.invent.2021.100402
2. Long-term efficacy of audiologist-guided Internet-based cognitive behaviour therapy for tinnitus in the United States: A repeated-measures design.
   Beukes EW, Andersson G, Manchaiah V. · · 2022 · cited 6× · PMID 36353148 · DOI 10.1016/j.invent.2022.100583
3. Individuals with Tinnitus Report More Positive Experiences following Internet-Based Cognitive Behavioral Therapy.
   Manchaiah V, Beukes EW, Andersson G, Bateman E, et al · · 2024 · cited 4× · PMID 39194934 · DOI 10.3390/clinpract14040130
4. Examining the consequences of tinnitus using the multidimensional perspective.
   Manchaiah V, Nisha KV, Prabhu P, Granberg S, et al · · 2022 · cited 4× · PMID 34964683 · DOI 10.1080/00016489.2021.2019307
5. Social Representations of "Tinnitus" and "Health" among Individuals with Tinnitus Seeking Online Psychological Interventions.
   Manchaiah V, Chundu S, Ratinaud P, Andersson G, et al · · 2023 · cited 3× · PMID 36960981 · DOI 10.3390/audiolres13020020
6. The positive side of living with tinnitus: a cross-sectional study.
   Loughlin J, Das V, Manchaiah V, Beukes E, et al · · 2024 · cited 2× · PMID 37004170 · DOI 10.1080/14992027.2023.2185756
7. Development and Psychometric Validation of Tinnitus Qualities and Impact Questionnaire.
   Manchaiah V, Andersson G, Beukes EW, Fagelson MA, et al · · 2025 · cited 1× · PMID 40422268 · DOI 10.3390/clinpract15050087
8. Exploring the Impact of Tinnitus on Work Productivity
   Beukes E, Sharpe J, Andersson G, Manchaiah V. · · 2026