Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 5:33 PM
Study NCT ID:
NCT04004260
Status:
COMPLETED
Last Update Posted:
2021-08-11
First Post:
2019-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CBT-based Internet Intervention for Adults With Tinnitus in the United States
Sponsor:
Lamar University
Organization:
Study Overview
Official Title:
Cognitive Behavior Therapy Based Self-help Delivered Via the Internet for Tinnitus Sufferers: Efficacy Trial in the U.S. Population
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 in the U.S. (less than 1%), partly attributed to a lack of trained professionals who can deliver CBT. To improve access to CBT for tinnitus, and online CBT program has been developed. The purpose of this study is to determine the feasibility and efficacy of a CBT Internet-based intervention for adults with tinnitus in the United States.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: