NCT04004260

CBT-based Internet Intervention for Adults With Tinnitus in the United States

Completed NA Results posted Last updated 11 August 2021

What this trial tests

NA trial testing Internet-based Cognitive Behavior Therapy in Tinnitus in 315 participants. Completed in 3 July 2020.

Timeline

1 March 2020

Primary endpoint
3 July 2020

3 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	315
Start date	1 March 2020
Primary completion	3 July 2020
Estimated completion	3 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 after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention

The Tinnitus Functional Index (TFI) is a 25-item questionnaire that evaluates tinnitus distress. The total possible score ranges from 0-to-100 with higher scores indicate 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
Experimental Group	54.04	± 17.85
Weekly check-in Control Group	53.93	± 17.32

T1: Post-intervention for experimental group

Group	Value	95% CI
Experimental Group	29.44	± 19.60
Weekly check-in Control Group	47.35	± 21.25

T2: Post-intervention for the control group

Group	Value	95% CI
Experimental Group	25.10	± 19.46
Weekly check-in Control Group	38.50	± 21.36

T3: 2-month post-intervention

Group	Value	95% CI
Experimental Group	25.10	± 19.46
Weekly check-in Control Group	32.82	± 14.70

Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition Secondary · Baseline, Post-intervention (8-weeks from baseline), 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
Experimental Group	39.63	± 17.38
Weekly check-in Control Group	37.95	± 14.54

T1: Post-intervention for the experimental group

Group	Value	95% CI
Experimental Group	26.03	± 15.58
Weekly check-in Control Group	26.03	± 16.80

T2: Post-intervention for the control group

Group	Value	95% CI
Experimental Group	40.57	± 15.72
Weekly check-in Control Group	32.26	± 15.54

T3: 2-month post-intervention

Group	Value	95% CI
Experimental Group	40.57	± 15.72
Weekly check-in Control Group	28.55	± 17

Patient Health Questionnaire (PHQ-9); Measure of Depression Secondary · Baseline, Post-intervention (8-weeks from baseline), 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
Experimental Group	5.54	± 4.17
Weekly check-in Control Group	5.42	± 4.1

T1: Post-intervention for the experimental group

Group	Value	95% CI
Experimental Group	4.41	± 4.74
Weekly check-in Control Group	5.91	± 4.35

T2: Post-intervention for the control group

Group	Value	95% CI
Experimental Group	3.17	± 4.01
Weekly check-in Control Group	4.20	± 3.8

T3: 2-month post-intervention

Group	Value	95% CI
Experimental Group	3.17	± 4.01
Weekly check-in Control Group	3.70	± 4.73

Generalized Anxiety Disorder (GAD-7); Measure of Anxiety Secondary · Baseline, Post-intervention (8-weeks from baseline), 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
Experimental Group	5.97	± 4.22
Weekly check-in Control Group	5.23	± 4.29

T1: Post-intervention for the experimental group

Group	Value	95% CI
Experimental Group	4.8	± 4.84
Weekly check-in Control Group	5.35	± 4.59

T2: Post-intervention for the control group

Group	Value	95% CI
Experimental Group	3.77	± 4.65
Weekly check-in Control Group	3.77	± 3.52

T3: 2-month post-intervention

Group	Value	95% CI
Experimental Group	3.77	± 4.65
Weekly check-in Control Group	5.17	± 5.58

Insomnia Severity Index (ISI); Measure of Insomnia Secondary · Baseline, Post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline)

Insomnia Severity Index (ISI) is a 7-item questionnaire that evaluates the severity of 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.e., worse outcome).

T0: Baseline

Group	Value	95% CI
Experimental Group	10.18	± 5.99
Weekly check-in Control Group	9.92	± 5.71

T1: Post-intervention for the experimental group

Group	Value	95% CI
Experimental Group	5.98	± 4.8
Weekly check-in Control Group	9.97	± 6.39

T2: Post-intervention for the control group

Group	Value	95% CI
Experimental Group	4.97	± 5.0
Weekly check-in Control Group	7.70	± 5.56

T3: 2-months post-intervention

Group	Value	95% CI
Experimental Group	4.97	± 5.0
Weekly check-in Control Group	5.77	± 6.24

EuroQol EQ-5D-5L VAS Scores; Measure of Health-related Quality of Life Secondary · T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention

EQ-5D-5L VAS is a single questionnaire that evaluates the health-related quality of life. Responses are marked on a 0-100 scale with higher scores indicate the higher overall health-related quality of life (i.e., better outcome).

T0: Baseline

Group	Value	95% CI
Experimental Group	78.23	± 13.14
Weekly check-in Control Group	75.51	± 13.96

T1: Post-intervention for the experimental group

Group	Value	95% CI
Experimental Group	79.68	± 15.66
Weekly check-in Control Group	76.02	± 13.7

T2: Post-intervention for the control group

Group	Value	95% CI
Experimental Group	80.79	± 16.16
Weekly check-in Control Group	78.52	± 13.29

T3: 2-month post-intervention

Group	Value	95% CI
Experimental Group	80.79	± 16.16
Weekly check-in Control Group	78.05	± 21.44

Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem Secondary · T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; 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 problems and the ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The to

T0: Baseline

Group	Value	95% CI
Experimental Group	5.80	± 3.9
Weekly check-in Control Group	5.51	± 3.52

T1: Post-intervention for the experimental group

Group	Value	95% CI
Experimental Group	2.68	± 2.47
Weekly check-in Control Group	5.31	± 3.82

T2: Post-intervention for the control group

Group	Value	95% CI
Experimental Group	2.35	± 3.4
Weekly check-in Control Group	3.46	± 3.10

T3: 2-month post-intervention

Group	Value	95% CI
Experimental Group	2.35	± 3.4
Weekly check-in Control Group	2.86	± 3.68

Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem Secondary · T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; 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 problems and the ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). Howeve

T0: Baseline

Group	Value	95% CI
Experimental Group	6.89	± 4.5
Weekly check-in Control Group	7.30	± 4.79

T1: Post-intervention for the experimental group

Group	Value	95% CI
Experimental Group	3.83	± 3.65
Weekly check-in Control Group	7.29	± 4.94

T2: Post-intervention for the control group

Group	Value	95% CI
Experimental Group	3.21	± 3.2
Weekly check-in Control Group	6.46	± 4.05

T3: 2-month post-intervention

Group	Value	95% CI
Experimental Group	3.21	± 3.2
Weekly check-in Control Group	4.14	± 3.37

Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance Secondary · T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; 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 problems and the ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). Howeve

T0: Baseline

Group	Value	95% CI
Experimental Group	.87	± 1.3
Weekly check-in Control Group	.8	± 1.1

T1: Post-intervention for the experimental group

Group	Value	95% CI
Experimental Group	.54	± .84
Weekly check-in Control Group	1.0	± 1.3

T2: Post-intervention for the control group

Group	Value	95% CI
Experimental Group	.47	± .79
Weekly check-in Control Group	.76	± 1.14

T3: 2-month post-intervention

Group	Value	95% CI
Experimental Group	.47	± .79
Weekly check-in Control Group	.64	± .9

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 in the U.S. (less than 1%), partly attributed to a lack of trained professionals who can deliver CBT. To improve access to CBT for tinnitus, and online CBT program has been developed. The purpose of this study is to determine the feasibility and efficacy of a CBT Internet-based intervention for adults with tinnitus in the United States.

Publications & conference data

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

1. Cognitive behavioural therapy for tinnitus.
   Fuller T, Cima R, Langguth B, Mazurek B, et al · · 2020 · cited 121× · PMID 31912887 · DOI 10.1002/14651858.cd012614.pub2
2. Internet-Based Audiologist-Guided Cognitive Behavioral Therapy for Tinnitus: Randomized Controlled Trial.
   W Beukes E, Andersson G, Fagelson M, Manchaiah V. · · 2022 · cited 30× · PMID 35156936 · DOI 10.2196/27584
3. Translation and adaptation of three English tinnitus patient-reported outcome measures to Spanish.
   Manchaiah V, Muñoz MF, Hatfield E, Fagelson MA, et al · · 2020 · cited 13× · PMID 31994949 · DOI 10.1080/14992027.2020.1717006
4. Use of open-ended questionnaires to examine the effects of tinnitus and its relation to patient-reported outcome measures.
   Manchaiah V, Andersson G, Fagelson MA, Boyd RL, et al · · 2022 · cited 9× · PMID 34726543 · DOI 10.1080/14992027.2021.1995790
5. 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
6. 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
7. 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
8. Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States.
   Beukes EW, Andersson G, Manchaiah V. · · 2021 · cited 4× · PMID 34869490 · DOI 10.3389/fmed.2021.771646