Trial Outcomes & Findings for CBT-based Internet Intervention for Adults With Tinnitus in the United States (NCT NCT04004260)

Last Updated: 2021-08-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

315 participants

Primary outcome timeframe

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

Results posted on

2021-08-11

Participant Flow

315 participants completed the informed consent and completed the pre-intervention screening measures. However, 157 participants were excluded (49 participants reported high depression and/or positive answers to self-harm questions, 37 participants had low tinnitus severity, 71 participants resided outside the state/country) and the remaining 158 were included in the study.

Participant milestones

Participant milestones
Measure	Experimental Group The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Overall Study STARTED	79	79
Overall Study COMPLETED	37	47
Overall Study NOT COMPLETED	42	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Group The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Overall Study Withdrawal by Subject	7	3
Overall Study Lost to Follow-up	22	12
Overall Study Did not engage in intervention	13	17

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=79 Participants The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group n=79 Participants The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Total n=158 Participants Total of all reporting groups
Age, Continuous	56 Years STANDARD_DEVIATION 13 • n=5 Participants	58 Years STANDARD_DEVIATION 11 • n=7 Participants	57 Years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	41 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants n=5 Participants	68 Participants n=7 Participants	138 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	74 Participants n=7 Participants	148 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	79 Participants n=5 Participants	79 Participants n=7 Participants	158 Participants n=5 Participants
Tinnitus Functional Index (TFI)	54.04 score on a scale STANDARD_DEVIATION 17.85 • n=5 Participants	53.93 score on a scale STANDARD_DEVIATION 17.32 • n=7 Participants	53.98 score on a scale STANDARD_DEVIATION 17.53 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: 79 participants started the trial in both the experimental group and control group 41 participants from the experimental group and 66 from the control group completed the post-intervention measure at T137 participants from the experimental group and 47 from the control group completed the post-intervention measure at T2 37 participants from the experimental group and 25 from the control group completed the 2-month post-intervention measure

Outcome measures

Outcome measures
Measure	Experimental Group n=79 Participants The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group n=79 Participants The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Tinnitus Functional Index (TFI) - Measure of Tinnitus Distress T3: 2-month post-intervention	25.10 score on a scale Standard Deviation 19.46	32.82 score on a scale Standard Deviation 14.70
Tinnitus Functional Index (TFI) - Measure of Tinnitus Distress T0: Baseline	54.04 score on a scale Standard Deviation 17.85	53.93 score on a scale Standard Deviation 17.32
Tinnitus Functional Index (TFI) - Measure of Tinnitus Distress T1: Post-intervention for experimental group	29.44 score on a scale Standard Deviation 19.60	47.35 score on a scale Standard Deviation 21.25
Tinnitus Functional Index (TFI) - Measure of Tinnitus Distress T2: Post-intervention for the control group	25.10 score on a scale Standard Deviation 19.46	38.50 score on a scale Standard Deviation 21.36

SECONDARY outcome

Timeframe: 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 range from 0 to 104. A high score represents a greater tendency to engage in negative cognitions (i.e., worse outcome) in response to tinnitus and low engagement in positive cognitions.

Outcome measures

Outcome measures
Measure	Experimental Group n=79 Participants The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group n=79 Participants The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition T0: Baseline	39.63 score on a scale Standard Deviation 17.38	37.95 score on a scale Standard Deviation 14.54
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition T1: Post-intervention for the experimental group	26.03 score on a scale Standard Deviation 15.58	26.03 score on a scale Standard Deviation 16.80
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition T2: Post-intervention for the control group	40.57 score on a scale Standard Deviation 15.72	32.26 score on a scale Standard Deviation 15.54
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition T3: 2-month post-intervention	40.57 score on a scale Standard Deviation 15.72	28.55 score on a scale Standard Deviation 17

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Experimental Group n=79 Participants The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group n=79 Participants The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Patient Health Questionnaire (PHQ-9); Measure of Depression T0: Baseline	5.54 score on a scale Standard Deviation 4.17	5.42 score on a scale Standard Deviation 4.1
Patient Health Questionnaire (PHQ-9); Measure of Depression T1: Post-intervention for the experimental group	4.41 score on a scale Standard Deviation 4.74	5.91 score on a scale Standard Deviation 4.35
Patient Health Questionnaire (PHQ-9); Measure of Depression T2: Post-intervention for the control group	3.17 score on a scale Standard Deviation 4.01	4.20 score on a scale Standard Deviation 3.8
Patient Health Questionnaire (PHQ-9); Measure of Depression T3: 2-month post-intervention	3.17 score on a scale Standard Deviation 4.01	3.70 score on a scale Standard Deviation 4.73

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Experimental Group n=79 Participants The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group n=79 Participants The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety T0: Baseline	5.97 score on a scale Standard Deviation 4.22	5.23 score on a scale Standard Deviation 4.29
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety T1: Post-intervention for the experimental group	4.8 score on a scale Standard Deviation 4.84	5.35 score on a scale Standard Deviation 4.59
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety T2: Post-intervention for the control group	3.77 score on a scale Standard Deviation 4.65	3.77 score on a scale Standard Deviation 3.52
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety T3: 2-month post-intervention	3.77 score on a scale Standard Deviation 4.65	5.17 score on a scale Standard Deviation 5.58

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Experimental Group n=79 Participants The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group n=79 Participants The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Insomnia Severity Index (ISI); Measure of Insomnia T0: Baseline	10.18 score on a scale Standard Deviation 5.99	9.92 score on a scale Standard Deviation 5.71
Insomnia Severity Index (ISI); Measure of Insomnia T1: Post-intervention for the experimental group	5.98 score on a scale Standard Deviation 4.8	9.97 score on a scale Standard Deviation 6.39
Insomnia Severity Index (ISI); Measure of Insomnia T2: Post-intervention for the control group	4.97 score on a scale Standard Deviation 5.0	7.70 score on a scale Standard Deviation 5.56
Insomnia Severity Index (ISI); Measure of Insomnia T3: 2-months post-intervention	4.97 score on a scale Standard Deviation 5.0	5.77 score on a scale Standard Deviation 6.24

SECONDARY outcome

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).

Outcome measures

Outcome measures
Measure	Experimental Group n=79 Participants The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group n=79 Participants The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
EuroQol EQ-5D-5L VAS Scores; Measure of Health-related Quality of Life T3: 2-month post-intervention	80.79 score on a scale Standard Deviation 16.16	78.05 score on a scale Standard Deviation 21.44
EuroQol EQ-5D-5L VAS Scores; Measure of Health-related Quality of Life T0: Baseline	78.23 score on a scale Standard Deviation 13.14	75.51 score on a scale Standard Deviation 13.96
EuroQol EQ-5D-5L VAS Scores; Measure of Health-related Quality of Life T1: Post-intervention for the experimental group	79.68 score on a scale Standard Deviation 15.66	76.02 score on a scale Standard Deviation 13.7
EuroQol EQ-5D-5L VAS Scores; Measure of Health-related Quality of Life T2: Post-intervention for the control group	80.79 score on a scale Standard Deviation 16.16	78.52 score on a scale Standard Deviation 13.29

SECONDARY outcome

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 total THS score can range from 0 to 40. However, the scores for this specific sub-scale can range from 0 to 16 with higher scores indicating more tinnitus problem (i.e., worse outcome).

Outcome measures

Outcome measures
Measure	Experimental Group n=79 Participants The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group n=79 Participants The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem T0: Baseline	5.80 score on a scale Standard Deviation 3.9	5.51 score on a scale Standard Deviation 3.52
Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem T1: Post-intervention for the experimental group	2.68 score on a scale Standard Deviation 2.47	5.31 score on a scale Standard Deviation 3.82
Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem T2: Post-intervention for the control group	2.35 score on a scale Standard Deviation 3.4	3.46 score on a scale Standard Deviation 3.10
Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem T3: 2-month post-intervention	2.35 score on a scale Standard Deviation 3.4	2.86 score on a scale Standard Deviation 3.68

SECONDARY outcome

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). However, the scores for this specific sub-scale can range from 0 to 16 with higher scores indicating more hearing problem (i.e., worse outcome).

Outcome measures

Outcome measures
Measure	Experimental Group n=79 Participants The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group n=79 Participants The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem T0: Baseline	6.89 score on a scale Standard Deviation 4.5	7.30 score on a scale Standard Deviation 4.79
Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem T1: Post-intervention for the experimental group	3.83 score on a scale Standard Deviation 3.65	7.29 score on a scale Standard Deviation 4.94
Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem T2: Post-intervention for the control group	3.21 score on a scale Standard Deviation 3.2	6.46 score on a scale Standard Deviation 4.05
Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem T3: 2-month post-intervention	3.21 score on a scale Standard Deviation 3.2	4.14 score on a scale Standard Deviation 3.37

SECONDARY outcome

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). However, the scores for this specific sub-scale can range from 0 to 8 with higher scores indicating more sound tolerance problem (i.e., worse outcome).

Outcome measures

Outcome measures
Measure	Experimental Group n=79 Participants The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.	Weekly check-in Control Group n=79 Participants The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention. Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance T0: Baseline	.87 score on a scale Standard Deviation 1.3	.8 score on a scale Standard Deviation 1.1
Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance T1: Post-intervention for the experimental group	.54 score on a scale Standard Deviation .84	1.0 score on a scale Standard Deviation 1.3
Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance T2: Post-intervention for the control group	.47 score on a scale Standard Deviation .79	.76 score on a scale Standard Deviation 1.14
Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance T3: 2-month post-intervention	.47 score on a scale Standard Deviation .79	.64 score on a scale Standard Deviation .9

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Weekly check-in Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vinaya Manchaiah, Jo Mayo Endowed Professor

Lamar University

Phone: (409) 821 9443

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place