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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-ICBT | Experimental | 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. |
|
| F-ICBT | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based Cognitive Behavior Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinaya Manchaiah, PhD | Lamar University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lamar University | Beaumont | Texas | 77705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34040997 | Result | Beukes EW, Andersson G, Fagelson MA, Manchaiah V. Dismantling internet-based cognitive behavioral therapy for tinnitus. The contribution of applied relaxation: A randomized controlled trial. Internet Interv. 2021 May 12;25:100402. doi: 10.1016/j.invent.2021.100402. eCollection 2021 Sep. |
| Label | URL |
|---|---|
| Study website | View source |
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The data that support the findings of this study are openly available in Figshare at https://doi.org/10.6084/m9.figshare.13679179
Available now
Data are openly available
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | R-ICBT | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 |
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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
Our definition of adverse events is the same as clinical trials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | R-ICBT | 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. |
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The study was done during the height of the COVID-19 pandemic, during a time where day-to-day living was disrupted for most people. This may have been one of the key reasons for poor engagement with the intervention and poor compliance with the completion of outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vinaya Manchaiah, Jo Mayo Endowed Professor | Lamar University | (409) 812 9443 | vmanchaiah@lamar.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2021 | Jun 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| 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); 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). | 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); 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). | 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); 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). | 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 |
| 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). | 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) - 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). | 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) - 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). | 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) - 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). | 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 |
| Did not engage in the intervention |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Tinnitus Functional Index (TFI) | Mean | Standard Deviation | score on a scale |
|
| OG000 |
| R-ICBT |
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. |
| OG001 | 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. |
|
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| 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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). | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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). | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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). | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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). | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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). | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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). | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
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| 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). | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 |
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|
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| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | 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. | 0 | 63 | 0 | 63 | 0 | 63 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| T1: Post-intervention 1 |
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| T2: Post-intervention 2 (both completed full ICBT) |
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| T3: 2-month post-intervention |
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| T1: Post-intervention 1 |
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| T2: Post-intervention 2 (both completed full ICBT) |
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| T3: 2-month post-intervention |
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| T1: Post-intervention 1 |
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| T2: Post-intervention 2 (both completed full ICBT) |
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| T3: 2-month post-intervention |
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| T1: Post-intervention 1 |
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| T2: Post-intervention 2 (both completed full ICBT) |
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| T3: 2-month post-intervention |
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| T1: Post-intervention 1 |
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| T2: Post-intervention 2 (both completed full ICBT) |
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| T3: 2-month post-intervention |
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| T1: Post-intervention 1 |
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| T2: Post-intervention 2 (both completed full ICBT) |
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| T3: 2-month post-intervention |
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| T1: Post-intervention 1 |
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| T2: Post-intervention 2 (both completed full ICBT) |
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| T3: 2-month post-intervention |
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| T1: Post-intervention 1 |
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| T2: Post-intervention 2 (both completed full ICBT) |
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| T3: 2-month post-intervention |
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