Tinnitus
Conditions
Brief 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.
Detailed description
Objective: To examine the difference in outcomes of relaxation-based Internet-based cognitive behavioral therapy (R-ICBT) versus full version of Internet-based cognitive behavioral therapy (F-ICBT) for tinnitus sufferers. Hypothesis: It is hypothesized that F-ICBT (experimental group) is superior when compared to R-ICBT (control group) in reducing the tinnitus-related distress, decreasing sleep disturbance, decreasing anxiety and depression, and improving health-related quality of life. The investigators also hypothesize that these results will be stable in both short- and long-term post-intervention. Design: A two-armed Randomized Control Trial (RCT), with a one-year follow-up design will be used to evaluate the efficacy of F-ICBT and R-ICBT on tinnitus distress. Setting: This will be an Internet-based study for adults with tinnitus living in the USA. Participants: Eligible participants will include adults with tinnitus for a minimum period of 3 months with internet access and no major medical or psychiatric conditions. 100 participants will be recruited for each group and will be randomly assigned using a computer-generated randomization schedule by an independent research assistant after being pre-stratified for tinnitus severity and depression severity. Intervention: The intervention offered to experimental group is a guided CTB-based internet intervention (ICBT), 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. The experimental group will be given the full ICBT program with all the components (22 chapters), whereas the control group will get only the relaxation-based exercises (8 chapters) of the ICBT program. Outcome measures: The main outcome measure is the Tinnitus Functional Index (TFI). Secondary outcome measures are the Tinnitus and Hearing Survey (THS), Tinnitus Cognition Questionnaire (TCQ), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), Insomnia Severity Index (ISI), and EuroQol EQ-5D-5L VAS.
Interventions
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.
Sponsors
Lamar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. aged 18 years and older living in the USA; 2. the ability to read and type in English; 3. no barriers to using a computer (e.g. no significant fine motor control or visual problems); 4. Internet and e-mail access and the ability to use it; 5. commitment to completing the program; 6. completion of the online screening and outcome questionnaires; 7. agree to participate in either group and be randomized to one of these groups; 8. 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; 9. be available for 12 months after starting the study to complete a 1-year follow-up questionnaire; and 10. experience bothersome tinnitus for a minimum period of 3 months;
Exclusion criteria
1. reporting any major medical or psychiatric conditions; 2. reporting pulsatile, objective or unilateral tinnitus, which has not been investigated medically; 3. tinnitus as a consequence of a medical disorder, still under investigation; and 4. undergoing any other tinnitus therapy while participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Functional Index (TFI); Measure of Tinnitus Distress | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9); Measure of Depression | 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). |
| Generalized Anxiety Disorder (GAD-7); Measure of Anxiety | 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). |
| Insomnia Severity Index (ISI); Measure of Insomnia | 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). |
| Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition | 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 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. |
| Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem | 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 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). |
| Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem | 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 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 hearing problem (i.e., worse outcome). |
| Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance | 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 THS score can range from 0 to 40. 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). |
| EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life | 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). |
Countries
United States
Participant flow
Recruitment details
135 participants completed the informed consent 9 participants were excluded (5 outside the country and 4 were no longer interested) 126 participants were included in the study
Participants by arm
| Arm | Count |
|---|---|
| R-CBT The intervention offered is a guided relaxation-based CBT offered via the Internet. 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. The modules provided will focus on applied relaxation only.
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. | 63 |
| F-ICBT 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. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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. | 63 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not engage in the intervention | 22 | 18 |
| Overall Study | Lost to Follow-up | 12 | 12 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | R-CBT | Total | F-ICBT |
|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 13 | 56 years STANDARD_DEVIATION 13 | 55 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 118 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 58 Participants | 114 Participants | 56 Participants |
| Region of Enrollment United States | 63 participants | 126 participants | 63 participants |
| Sex: Female, Male Female | 25 Participants | 62 Participants | 37 Participants |
| Sex: Female, Male Male | 38 Participants | 64 Participants | 26 Participants |
| Tinnitus Functional Index (TFI) | 50.52 score on a scale STANDARD_DEVIATION 26.65 | 49.61 score on a scale STANDARD_DEVIATION 26 | 48.70 score on a scale STANDARD_DEVIATION 25.51 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 0 / 63 | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
Primary
Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
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.
Time frame: 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
Population: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R-ICBT | Tinnitus Functional Index (TFI); Measure of Tinnitus Distress | T0: Baseline | 48.7 score on a scale | Standard Deviation 25.51 |
| R-ICBT | Tinnitus Functional Index (TFI); Measure of Tinnitus Distress | T1: Post-intervention 1 | 32.13 score on a scale | Standard Deviation 21.38 |
| R-ICBT | Tinnitus Functional Index (TFI); Measure of Tinnitus Distress | T2: Post-intervention 2 (both completed full ICBT) | 30.66 score on a scale | Standard Deviation 23.45 |
| R-ICBT | Tinnitus Functional Index (TFI); Measure of Tinnitus Distress | T3: 2-month post-intervention | 23.81 score on a scale | Standard Deviation 9.87 |
| F-ICBT | Tinnitus Functional Index (TFI); Measure of Tinnitus Distress | T3: 2-month post-intervention | 27.16 score on a scale | Standard Deviation 20.78 |
| F-ICBT | Tinnitus Functional Index (TFI); Measure of Tinnitus Distress | T0: Baseline | 50.52 score on a scale | Standard Deviation 26.65 |
| F-ICBT | Tinnitus Functional Index (TFI); Measure of Tinnitus Distress | T2: Post-intervention 2 (both completed full ICBT) | 28.95 score on a scale | Standard Deviation 20.75 |
| F-ICBT | Tinnitus Functional Index (TFI); Measure of Tinnitus Distress | T1: Post-intervention 1 | 28.95 score on a scale | Standard Deviation 20.75 |
Secondary
EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life
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).
Time frame: 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
Population: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R-ICBT | EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life | T2: Post-intervention 2 (both completed full ICBT) | 76.43 score on a scale | Standard Deviation 15.79 |
| R-ICBT | EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life | T3: 2-month post-intervention | 78.22 score on a scale | Standard Deviation 11.29 |
| R-ICBT | EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life | T0: Baseline | 72.59 score on a scale | Standard Deviation 17 |
| R-ICBT | EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life | T1: Post-intervention 1 | 79.71 score on a scale | Standard Deviation 12.14 |
| F-ICBT | EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life | T1: Post-intervention 1 | 78.15 score on a scale | Standard Deviation 17.51 |
| F-ICBT | EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life | T2: Post-intervention 2 (both completed full ICBT) | 78.15 score on a scale | Standard Deviation 17.51 |
| F-ICBT | EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life | T0: Baseline | 75.43 score on a scale | Standard Deviation 15.92 |
| F-ICBT | EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life | T3: 2-month post-intervention | 85.87 score on a scale | Standard Deviation 6.91 |
Secondary
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
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).
Time frame: 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
Population: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R-ICBT | Generalized Anxiety Disorder (GAD-7); Measure of Anxiety | T2: Post-intervention 2 (both completed full ICBT) | 4.86 score on a scale | Standard Deviation 5.84 |
| R-ICBT | Generalized Anxiety Disorder (GAD-7); Measure of Anxiety | T3: 2-month post-intervention | 3.70 score on a scale | Standard Deviation 3.88 |
| R-ICBT | Generalized Anxiety Disorder (GAD-7); Measure of Anxiety | T0: Baseline | 7.75 score on a scale | Standard Deviation 6.77 |
| R-ICBT | Generalized Anxiety Disorder (GAD-7); Measure of Anxiety | T1: Post-intervention 1 | 5.21 score on a scale | Standard Deviation 5.62 |
| F-ICBT | Generalized Anxiety Disorder (GAD-7); Measure of Anxiety | T1: Post-intervention 1 | 4.48 score on a scale | Standard Deviation 4.17 |
| F-ICBT | Generalized Anxiety Disorder (GAD-7); Measure of Anxiety | T2: Post-intervention 2 (both completed full ICBT) | 4.48 score on a scale | Standard Deviation 4.17 |
| F-ICBT | Generalized Anxiety Disorder (GAD-7); Measure of Anxiety | T0: Baseline | 9.19 score on a scale | Standard Deviation 6.39 |
| F-ICBT | Generalized Anxiety Disorder (GAD-7); Measure of Anxiety | T3: 2-month post-intervention | 4.68 score on a scale | Standard Deviation 4.75 |
Secondary
Insomnia Severity Index (ISI); Measure of Insomnia
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).
Time frame: 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
Population: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R-ICBT | Insomnia Severity Index (ISI); Measure of Insomnia | T0: Baseline | 11.90 score on a scale | Standard Deviation 7.45 |
| R-ICBT | Insomnia Severity Index (ISI); Measure of Insomnia | T2: Post-intervention 2 (both completed full ICBT) | 8.43 score on a scale | Standard Deviation 5.93 |
| R-ICBT | Insomnia Severity Index (ISI); Measure of Insomnia | T1: Post-intervention 1 | 8.93 score on a scale | Standard Deviation 6.5 |
| R-ICBT | Insomnia Severity Index (ISI); Measure of Insomnia | T3: 2-month post-intervention | 7.13 score on a scale | Standard Deviation 5 |
| F-ICBT | Insomnia Severity Index (ISI); Measure of Insomnia | T3: 2-month post-intervention | 6.33 score on a scale | Standard Deviation 6.08 |
| F-ICBT | Insomnia Severity Index (ISI); Measure of Insomnia | T2: Post-intervention 2 (both completed full ICBT) | 7.46 score on a scale | Standard Deviation 5.8 |
| F-ICBT | Insomnia Severity Index (ISI); Measure of Insomnia | T0: Baseline | 12.25 score on a scale | Standard Deviation 7.7 |
| F-ICBT | Insomnia Severity Index (ISI); Measure of Insomnia | T1: Post-intervention 1 | 7.46 score on a scale | Standard Deviation 5.8 |
Secondary
Patient Health Questionnaire (PHQ-9); Measure of Depression
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).
Time frame: 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
Population: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R-ICBT | Patient Health Questionnaire (PHQ-9); Measure of Depression | T1: Post-intervention 1 | 4.96 score on a scale | Standard Deviation 5.07 |
| R-ICBT | Patient Health Questionnaire (PHQ-9); Measure of Depression | T0: Baseline | 9.17 score on a scale | Standard Deviation 7.12 |
| R-ICBT | Patient Health Questionnaire (PHQ-9); Measure of Depression | T2: Post-intervention 2 (both completed full ICBT) | 5.04 score on a scale | Standard Deviation 5.7 |
| R-ICBT | Patient Health Questionnaire (PHQ-9); Measure of Depression | T3: 2-month post-intervention | 3.35 score on a scale | Standard Deviation 4.17 |
| F-ICBT | Patient Health Questionnaire (PHQ-9); Measure of Depression | T3: 2-month post-intervention | 4.12 score on a scale | Standard Deviation 4.4 |
| F-ICBT | Patient Health Questionnaire (PHQ-9); Measure of Depression | T2: Post-intervention 2 (both completed full ICBT) | 4.32 score on a scale | Standard Deviation 3.95 |
| F-ICBT | Patient Health Questionnaire (PHQ-9); Measure of Depression | T0: Baseline | 9.10 score on a scale | Standard Deviation 7.14 |
| F-ICBT | Patient Health Questionnaire (PHQ-9); Measure of Depression | T1: Post-intervention 1 | 4.32 score on a scale | Standard Deviation 3.95 |
Secondary
Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
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 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 hearing problem (i.e., worse outcome).
Time frame: 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
Population: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R-ICBT | Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem | T2: Post-intervention 2 (both completed full ICBT) | 4.71 score on a scale | Standard Deviation 4.32 |
| R-ICBT | Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem | T1: Post-intervention 1 | 3.75 score on a scale | Standard Deviation 3.7 |
| R-ICBT | Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem | T3: 2-month post-intervention | 4.65 score on a scale | Standard Deviation 3.59 |
| R-ICBT | Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem | T0: Baseline | 6.19 score on a scale | Standard Deviation 4.84 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem | T3: 2-month post-intervention | 3.13 score on a scale | Standard Deviation 2.36 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem | T1: Post-intervention 1 | 4.59 score on a scale | Standard Deviation 4.01 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem | T2: Post-intervention 2 (both completed full ICBT) | 4.59 score on a scale | Standard Deviation 4.01 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem | T0: Baseline | 5.94 score on a scale | Standard Deviation 5.06 |
Secondary
Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
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 THS score can range from 0 to 40. 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).
Time frame: 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
Population: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R-ICBT | Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance | T0: Baseline | 1.17 score on a scale | Standard Deviation 1.4 |
| R-ICBT | Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance | T2: Post-intervention 2 (both completed full ICBT) | .96 score on a scale | Standard Deviation 1.3 |
| R-ICBT | Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance | T3: 2-month post-intervention | 0.91 score on a scale | Standard Deviation 1.08 |
| R-ICBT | Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance | T1: Post-intervention 1 | 1.0 score on a scale | Standard Deviation 1.39 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance | T3: 2-month post-intervention | 0.47 score on a scale | Standard Deviation 0.74 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance | T0: Baseline | 1.22 score on a scale | Standard Deviation 1.3 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance | T1: Post-intervention 1 | 0.67 score on a scale | Standard Deviation 1.07 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance | T2: Post-intervention 2 (both completed full ICBT) | .67 score on a scale | Standard Deviation 1.07 |
Secondary
Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem
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 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).
Time frame: 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
Population: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R-ICBT | Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem | T0: Baseline | 5.79 score on a scale | Standard Deviation 4.55 |
| R-ICBT | Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem | T1: Post-intervention 1 | 3.21 score on a scale | Standard Deviation 3.32 |
| R-ICBT | Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem | T2: Post-intervention 2 (both completed full ICBT) | 3.36 score on a scale | Standard Deviation 3.68 |
| R-ICBT | Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem | T3: 2-month post-intervention | 2.78 score on a scale | Standard Deviation 3.19 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem | T3: 2-month post-intervention | 2.07 score on a scale | Standard Deviation 2.12 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem | T0: Baseline | 6.29 score on a scale | Standard Deviation 5.7 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem | T2: Post-intervention 2 (both completed full ICBT) | 2.85 score on a scale | Standard Deviation 2.66 |
| F-ICBT | Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem | T1: Post-intervention 1 | 2.85 score on a scale | Standard Deviation 2.66 |
Secondary
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
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.
Time frame: 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
Population: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R-ICBT | Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition | T0: Baseline | 44.67 score on a scale | Standard Deviation 20.43 |
| R-ICBT | Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition | T1: Post-intervention 1 | 30.96 score on a scale | Standard Deviation 20.03 |
| R-ICBT | Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition | T2: Post-intervention 2 (both completed full ICBT) | 28.93 score on a scale | Standard Deviation 17.81 |
| R-ICBT | Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition | T3: 2-month post-intervention | 25.30 score on a scale | Standard Deviation 15.84 |
| F-ICBT | Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition | T3: 2-month post-intervention | 23.07 score on a scale | Standard Deviation 17.54 |
| F-ICBT | Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition | T0: Baseline | 42.52 score on a scale | Standard Deviation 18.58 |
| F-ICBT | Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition | T2: Post-intervention 2 (both completed full ICBT) | 27.26 score on a scale | Standard Deviation 20.17 |
| F-ICBT | Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition | T1: Post-intervention 1 | 27.26 score on a scale | Standard Deviation 20.17 |