Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers

NCT04335812 | Completed Results

• 1 other identifier: IRB-FY20-200-1
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Tinnitus Functional Index (TFI); Measure of Tinnitus Distress

  Tinnitus Functional Index (TFI) is a 25-item questionnaire that evaluates the severity of tinnitus distress. Total possible score ranges from 0-to-100 with higher scores suggesting more severe tinnitus distress (i.e., worse outcome). Scores \>25 indicate tinnitus is a significant problem requiring tinnitus intervention.

  T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

Secondary Outcomes (8)

• Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition

  T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

• Patient Health Questionnaire (PHQ-9); Measure of Depression

  T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

• Generalized Anxiety Disorder (GAD-7); Measure of Anxiety

  T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

• Insomnia Severity Index (ISI); Measure of Insomnia

  T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

• EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life

  T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention

Study Arms (2)

R-ICBT

EXPERIMENTAL

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.

Behavioral: Internet-based Cognitive Behavior Therapy

F-ICBT

ACTIVE COMPARATOR

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

Behavioral: Internet-based Cognitive Behavior Therapy

Interventions

Internet-based Cognitive Behavior Therapy 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.

Also known as: ICBT

F-ICBT; R-ICBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years and older living in the USA;
• the ability to read and type in English;
• 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;
• agree to participate in either group and be randomized to one of these groups;
• 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;
• be available for 12 months after starting the study to complete a 1-year follow-up questionnaire; and
• experience bothersome tinnitus for a minimum period of 3 months;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lamar University: lead

Study Sites (1)

Lamar University

Beaumont, Texas, 77705, United States

Location

Related Publications (1)

• 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.

  PMID: 34040997 RESULT

Related Links

• Study website

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was done during the height of the COVID-19 pandemic, during a time where day-to-day living was disrupted for most people. This may have been one of the key reasons for poor engagement with the intervention and poor compliance with the completion of outcome measures.

Results Point of Contact

• Title: Dr. Vinaya Manchaiah, Jo Mayo Endowed Professor
• Organization: Lamar University

vmanchaiah@lamar.edu

(409) 812 9443

Study Officials

• Vinaya Manchaiah, PhD

  Lamar University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jo Mayo Endowed Professor

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 6, 2020
• Study Start: May 4, 2020
• Primary Completion: July 24, 2020
• Study Completion: July 24, 2020
• Last Updated: July 16, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available now
• Access Criteria: Data are openly available

Locations

US (1)