Clinical trial NCT04335929: Internet-based Cognitive Behavioural Therapy for Spanish Tinnitus Sufferers
Official title: Internet-based Cognitive Behavioural Therapy for Spanish Tinnitus Sufferers: A Global Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Lamar University
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
timeFrame: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
Secondary outcomes:
measure: Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
timeFrame: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
measure: Patient Health Questionnaire (PHQ-9); Measure of Depression
timeFrame: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
measure: Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
timeFrame: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
measure: Insomnia Severity Index (ISI); Measure of Insomnia
timeFrame: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
measure: EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life
timeFrame: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
measure: Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem
timeFrame: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
measure: Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
timeFrame: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
measure: Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
timeFrame: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
Other outcomes:
Locations:
city: Beaumont
country: United States
facility: Lamar University
state: Texas
Study officials:
affiliation: Lamar University
name: Vinaya Manchaiah, PhD
role: PRINCIPAL_INVESTIGATOR
References: