Effectiveness of Specialised Cognitive Behavioural Therapy (CBT) for Tinnitus.

March 13, 2020 updated by: Maastricht University

Cognitive Behaviour Therapy (CBT) for Tinnitus Treatment: Implementation and Validity

This is an observational study of specialised CBT for tinnitus for adults delivered in routine care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with tinnitus

Description

Inclusion Criteria:

  • Tinnitus is the primary complaint and reason for seeking help
  • Participant is at least 17 years of age,

Exclusion Criteria:

  • Unable to read and write in Dutch
  • Tinnitus is not the primary complaint
  • Person is under 17 years of age
  • Participant has a health condition that prevents them from attending treatment centre
  • An Ear Nose Throat (ENT) physician assesses the participant as having ontological condition that requires medical treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Step 1 only
Participants in the study who only receive Step 1 of specialised CBT
Behavioral: CBT 1
CBT for tinnitus (Step 1) comprised: individual audiometric assessment, and counselling about hearing and tinnitus (1hr) with an audiologist; a one-off educational group session (a max 10 participants and partners) (2hrs); an assessment session with a psychologists (1 hr).
Step 1 and 2
Participants who receive both Step 1 and Step 2 of speciliased CBT for tinnitus.
Behavioral: CBT 1
CBT for tinnitus (Step 1) comprised: individual audiometric assessment, and counselling about hearing and tinnitus (1hr) with an audiologist; a one-off educational group session (a max 10 participants and partners) (2hrs); an assessment session with a psychologists (1 hr).
Behavioral: CBT 2
Step 2 group sessions were 2 hrs long over a 12-week period. Two therapists (a psychologist and physiotherapist) were present at any one time for Step 2 sessions. Step 2 included: psycho-education; exposure therapy; mindfulness exercises; cognitive restructuring; attention redirecting techniques; stress reduction; and, relaxation techniques. Evening sessions were also provided for participants to attend with family or partners.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health Utilities Index-III
Time Frame: 12 months
The Health Utilities Index (HUI; Feeny et al., 2002; Horsman, Furlong, Feeny, & Torrance, 2003) is a 17-item measure designed to assess health related quality of life.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Inventory (THI)
Time Frame: 12 months
The THI (Newman, Jacobson, & Spitzer, 1996; Newman, Sandridge, & Jacobson, 1998).is a 25 items measure of the impact of tinnitus on daily life that includes three subscales. The subscales cover functional (mental, social/occupational and physical functioning), emotional impact and catastrophic responses to tinnitus.
12 months
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983).
Time Frame: 12 months
The HADS is a widely used measure of psychological distress in people experiencing a concurrent physical health condition. It has 14 items and respondents use a Likert-type scale to indicate how often they have had a particular feeling in the previous week (e.g. "I feel tense or wound up").
12 months
Tinnitus Catastrophizing Scale (TCS)
Time Frame: 12 months
Tinnitus Catastrophizing Scale (TCS; Cima, Crombez, & Vlaeyen, 2011). The TCS was used to assess the degree to which people thought or expected the worst about tinnitus (i.e. catastrophizing). The TCS is a 13-item measure based on the Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995) and respondents use a five point scale to indicate the degree to which statements applies to them (e.g. It's terrible and I think it's never going to get any better). The total score on the TCS ranges from 0 to 65.
12 months
Fear of Tinnitus Questionnaire (FTQ)
Time Frame: 12 months
The FTQ is a 17-item self-report measure intended and designed to assess respondents' level of fear regarding their tinnitus. Items in the questionnaire are presented as a series of statements (e.g. "I am afraid that my tinnitus will become worse") from which respondents are asked to indicate if it is applicable to their current situation. Each statement receives a score of 1 when applicable. The total score is the sum of all applicable statements and provides an overall rating of fear of tinnitus and ranges from 0 to 17.
12 months
Tinnitus Questionnaire (TQ)
Time Frame: 12 months
The Tinnitus Questionnaire (TQ; Hallam, Jakes, & Hinchcliffe, 1988) is a self-report questionnaire designed to asses distress and interference in daily activities that is associated with tinnitus. It has 52 items and uses a three-point scale to indicate levels of distress on six subscales. The total possible score on the TQ ranges from 0-84.
12 months
Tinnitus Disability Index (TDI)
Time Frame: 12 months
The Tinnitus Disability Index (TDI; Cima, Vlaeyen, Maes, Joore, & Anteunis, 2011) is a seven-item self-report questionnaire that assesses the level of interferences in daily activities (such as occupational, social, and recreational) attributed to tinnitus. Respondents use an 11-point scale to indicate the level of interference ranging from 0 no disability, to 10 total disability. The total score ranges from 0 to 70 with higher scores indicating higher levels of interference.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SWOL Limburgs Fonds voor Revalidatie
Flemish Government, Belgium
The Netherlands Organization for Scientific Research (NWO)
Libra Revalidatie en Audiologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 16, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECP-152 05_12_2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings