Internet-based Cognitive Behavioural Therapy for Spanish Tinnitus Sufferers

NCT ID: NCT04335929

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2020-08-14

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 which is also available in Spanish. However, the outcomes of the Spanish version of the program has not been evaluated. The purpose of the current study is to determine the feasibility of guided Spanish version of the Internet-based CBT (ICBT) using audiological support on tinnitus distress and tinnitus-related comorbidities.

Detailed Description

Objective: The purpose of the current study is to determine the feasibility of guided Spanish version of the Internet-based CBT (ICBT) using audiological support on tinnitus distress and tinnitus-related comorbidities.

Hypothesis: It is hypothesized that Spanish version of the ICBT will reduce the tinnitus-related distress, decrease sleep disturbance, decrease anxiety and depression, and improve health-related quality of life in Spanish speaking tinnitus suffers. The investigators also hypothesize that these results will be stable in both short- and long-term post-intervention.

Design: A single group assignment, with a one-year follow-up design will be used to evaluate the feasibility of Spanish version of the ICBT on tinnitus distress.

Setting: This will be an Internet-based study for Spanish speaking tinnitus suffers living across the globe.

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. 50 Spanish speaking participants will be recruited.

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: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

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.

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

Eligibility Criteria

Inclusion Criteria

1. aged 18 years and older adults from across the globe;

2. the ability to read and type in 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. 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

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.tacklingtinnitus.org

Study website

Other Identifiers

IRB-FY20-200-2

Identifier Type: -

Identifier Source: org_study_id