CBT-based Internet Intervention for Adults With Tinnitus in the United States
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ClinicalTrials.gov Identifier: NCT04004260 |
Recruitment Status :
Completed
First Posted : July 2, 2019
Results First Posted : August 11, 2021
Last Update Posted : August 11, 2021
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Condition or disease | Intervention/treatment | Phase |
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Tinnitus | Behavioral: Internet-based Cognitive Behavior Therapy | Not Applicable |
Objective: This study aims to determine the feasibility and efficacy of an Internet-based Cognitive Behavior Therapy (ICBT) in reducing the impact associated with tinnitus in the United States.
Hypothesis: It is hypothesized that ICBT will result in reduced tinnitus-related distress, decreased sleep disturbance, decreased anxiety and depression, and improved health-related quality of life in a treatment group as compared with adults in the weekly check-in control-group in the U.S. population. 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 ICBT on tinnitus distress.
Setting: This will be an Internet-based study for adults with tinnitus living in the State of Texas, 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. 80 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 language and tinnitus severity.
Intervention: The intervention offered 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.
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 315 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The experimental group will initially undergo the ICBT intervention while the control group are monitored weekly. Once the experimental group has completed the intervention, the control group will undertake the ICBT intervention. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cognitive Behavior Therapy Based Self-help Delivered Via the Internet for Tinnitus Sufferers: Efficacy Trial in the U.S. Population |
Actual Study Start Date : | March 1, 2020 |
Actual Primary Completion Date : | July 3, 2020 |
Actual Study Completion Date : | July 3, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Behavioral: 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.
Other Name: ICBT |
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.
|
Behavioral: 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.
Other Name: ICBT |
- Tinnitus Functional Index (TFI) - Measure of Tinnitus Distress [ Time Frame: T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention ]The Tinnitus Functional Index (TFI) is a 25-item questionnaire that evaluates tinnitus distress. The total possible score ranges from 0-to-100 with higher scores indicate more severe tinnitus distress (i.e., worse outcome). Scores >25 indicate tinnitus is a significant problem requiring tinnitus intervention.
- Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition [ Time Frame: 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.
- Patient Health Questionnaire (PHQ-9); Measure of Depression [ Time Frame: 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).
- Generalized Anxiety Disorder (GAD-7); Measure of Anxiety [ Time Frame: 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).
- Insomnia Severity Index (ISI); Measure of Insomnia [ Time Frame: 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).
- EuroQol EQ-5D-5L VAS Scores; Measure of Health-related Quality of Life [ Time Frame: T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention ]EQ-5D-5L VAS is a single questionnaire that evaluates the health-related quality of life. Responses are marked on a 0-100 scale with higher scores indicate the higher overall health-related quality of life (i.e., better outcome).
- Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem [ Time Frame: T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention ]Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problems and the ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The 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 [ Time Frame: T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention ]Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problems and the ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). 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 [ Time Frame: T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention ]Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problems and the ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). 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).
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- aged 18 years and older living in the State of Texas, USA;
- the ability to read and type in English or Spanish;
- no barriers to using a computer (e.g. no significant fine motor control or visual problems);
- Internet and e-mail access and the ability to use it;
- commitment to completing the program;
- completion of the online screening and outcome questionnaires;
- agreeing to participate in either group and be randomized to one of these groups;
- understanding and working towards the end goal of reducing the impact and distress of tinnitus, although the strength of the tinnitus may remain the same;
- be available for 12 months after starting the study to complete a 1-year follow-up questionnaire;
- suffering with experiencing tinnitus for a minimum period of 3 months; and
- tinnitus outcome measure scores indicating the need for tinnitus care [25 or above on the Tinnitus Functional Index (TFI)].
Exclusion Criteria:
- reporting any major medical or psychiatric conditions;
- reporting pulsatile, objective or unilateral tinnitus, which has not been investigated medically;
- tinnitus as a consequence of a medical disorder, still under investigation; and
- undergoing any other tinnitus therapy while participating in this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004260
United States, Texas | |
Lamar University | |
Beaumont, Texas, United States, 77705 |
Principal Investigator: | Vinaya Manchaiah, PhD | Lamar University |
Documents provided by Vinaya Manchaiah, Lamar University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Vinaya Manchaiah, Jo Mayo Endowed Professor, Lamar University |
ClinicalTrials.gov Identifier: | NCT04004260 |
Other Study ID Numbers: |
R21DC017214 ( U.S. NIH Grant/Contract ) |
First Posted: | July 2, 2019 Key Record Dates |
Results First Posted: | August 11, 2021 |
Last Update Posted: | August 11, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The data that support the findings of this study are openly available in Figshare at http://doi.org/10.6084/m9.figshare.13646012 |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | Available now |
Access Criteria: | Data are openly available |
URL: | http://doi.org/10.6084/m9.figshare.13646012 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |