Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
200

Summary

Conditions
Tinnitus
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 (n=200). Hypothesis: It is hypothesized that F-ICBT (experimental group) is sup...

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 (n=200). 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.

Tracking Information

NCT #
NCT04335812
Collaborators
Not Provided
Investigators
Principal Investigator: Vinaya Manchaiah, PhD Lamar University