CBT-based Internet Intervention for Adults With Tinnitus in the United States

NCT ID: NCT04004260

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-07-03

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.

Conditions

Tinnitus

Study Design

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

Study Groups

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.

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.

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.

Group Type: OTHER

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 State of Texas, USA;

2. the ability to read and type in English or Spanish;

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. agreeing to participate in either group and be randomized to one of these groups;

8. 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;

9. be available for 12 months after starting the study to complete a 1-year follow-up questionnaire;

10. suffering with experiencing tinnitus for a minimum period of 3 months; and

11. tinnitus outcome measure scores indicating the need for tinnitus care [25 or above on the Tinnitus Functional Index (TFI)].

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

W Beukes E, Andersson G, Fagelson M, Manchaiah V. Internet-Based Audiologist-Guided Cognitive Behavioral Therapy for Tinnitus: Randomized Controlled Trial. J Med Internet Res. 2022 Feb 14;24(2):e27584. doi: 10.2196/27584.

Reference Type: DERIVED

PMID: 35156936 (View on PubMed)

Beukes EW, Andersson G, Manchaiah V. Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States. Front Med (Lausanne). 2021 Nov 17;8:771646. doi: 10.3389/fmed.2021.771646. eCollection 2021.

Reference Type: DERIVED

PMID: 34869490 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.tacklingtinnitus.org

Related Info

Other Identifiers

R21DC017214

Identifier Type: NIH

Identifier Source: org_study_id

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