Internet-based Cognitive Behavioural Therapy for Spanish Tinnitus Sufferers

Internet-based Cognitive Behavioural Therapy for Spanish Tinnitus Sufferers: A Global Pilot Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04335929

Acronym

ICBT

Enrollment

Registered

2020-04-07

Start date

2020-05-04

Completion date

2020-08-14

Last updated

2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

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.

Interventions

BEHAVIORALInternet-based Cognitive Behavior Therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Tinnitus Functional Index (TFI); Measure of Tinnitus Distress	T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)	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.

Secondary

Measure	Time frame	Description
Patient Health Questionnaire (PHQ-9); Measure of Depression	T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)	Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire that assesses depression severity. Responses are marked on a four-point Likert scale (0 to 3). The total score can range from 0 to 27 with higher scores indicating more severe depression (i.e., worse outcome).
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety	T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)	Generalized Anxiety Disorder (GAD-7) is a 7-item questionnaire that assesses the severity of anxiety. Responses are marked on a four-point Likert scale (0 to 3). The total score can range from 0 to 21 with higher scores indicating more severe anxiety (i.e., worse outcome).
Insomnia Severity Index (ISI); Measure of Insomnia	T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)	Insomnia Severity Index (ISI) is a 7-item questionnaire that evaluates insomnia. Responses are marked on a five-point Likert scale (0 to 4). The total score can range from 0 to 28 with higher scores indicating more severe insomnia (i.w., worse outcome).
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition	T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)	Tinnitus Cognition Questionnaire (TCQ) is a 26-item questionnaire that assesses positive and negative cognitions associated with tinnitus. The first 13 items refer to negative thoughts and the second 13 items refer to positive thoughts. Responses are marked on a five-point Likert scale (0 to 4). The negative items (1-13) are scored 0-4, whereas the positive items (14-26) are reverse-scored: 4-0. The scoring procedure involves the simple addition of the number circled by the respondent for items 1-13 and the addition of reverse-scored items 14-26. The total score of the TCQ has a potential range from 0 to 104. A high score represents a greater tendency to engage in negative cognitions (i.e., worse outcome) in response to tinnitus and low engagement in positive cognitions.
Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem	T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)	Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problem and ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The total THS score can range from 0 to 40. However, the scores for this specific sub-scale can range from 0 to 16 with higher scores indicating more tinnitus problem (i.e., worse outcome).
Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem	T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)	Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problem and ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The total THS score can range from 0 to 40. However, the scores for this specific sub-scale can range from 0 to 16 with higher scores indicating more hearing problem (i.e., worse outcome).
Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance	T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)	Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problem and ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The total THS score can range from 0 to 40. However, the scores for this specific sub-scale can range from 0 to 8 with higher scores indicating more sound tolerance problem (i.e., worse outcome).
EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life	T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)	EQ-5D-5L VAS is a single-item questionnaire that evaluates the health-related quality of life. Responses are marked on a 0-100 scale with higher scores indicating higher health-related quality o life (i.e., better outcome).

Countries

United States

Participant flow

Recruitment details

46 participants screened at baseline and completed informed consent 3 participants were excluded as they did not meet inclusion criteria 11 participants decided not to participate

Participants by arm

Arm	Count
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. 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.	32
Total	32

Arm

Count

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. 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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	10

Baseline characteristics

Characteristic	Internet-based Cognitive Behavior Therapy
Age, Continuous	46.63 years STANDARD_DEVIATION 11
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	26 Participants
Region of Enrollment Brazil	6 participants
Region of Enrollment Costa Rica	1 participants
Region of Enrollment France	1 participants
Region of Enrollment Germany	1 participants
Region of Enrollment Mexico	2 participants
Region of Enrollment Puerto Rico	2 participants
Region of Enrollment Spain	17 participants
Region of Enrollment Ukraine	2 participants
Sex: Female, Male Female	17 Participants
Sex: Female, Male Male	15 Participants
Tinnitus Functional Index (TFI); Measure of Tinnitus Distress	61.06 score on a scale STANDARD_DEVIATION 19.03

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 32
other Total, other adverse events	0 / 32
serious Total, serious adverse events	0 / 32

Outcome results

Primary

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.

Time frame: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)