Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers

NCT ID: NCT04335812

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2020-07-24

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.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Internet-based Cognitive Behavior Therapy

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Internet-based Cognitive Behavior Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ICBT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lamar University

OTHER

Sponsor Role: lead

Responsible Party

Vinaya Manchaiah

Jo Mayo Endowed Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vinaya Manchaiah, PhD

Role: PRINCIPAL_INVESTIGATOR

Lamar University

Locations

Lamar University

Beaumont, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 34040997 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.tacklingtinnitus.org

Study website

Other Identifiers

IRB-FY20-200-1

Identifier Type: -

Identifier Source: org_study_id