Tinnitus, SubjectiveNCT04310605
Effectiveness of Specialised Cognitive Behavioural Therapy (CBT) for Tinnitus.
An observational study of Tinnitus, Subjective, run by Maastricht University.
Trial summary
This is an observational study of specialised CBT for tinnitus for adults delivered in routine care. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- CBT 1 and CBT 2
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 16 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Child, Adult, Older adult
Study population: Adults with tinnitus
Who may be able to join
- Tinnitus is the primary complaint and reason for seeking help
- Participant is at least 17 years of age,
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Tinnitus, Subjective
- Being tested
- CBT 1, CBT 2
- Keywords
- tinnitus, CBT, cognitive behaviour therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT 1Behavioural
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).
CBT 2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Step 1 only | Participants in the study who only receive Step 1 of specialised CBT Receives: Behavioral: CBT 1 | |
| Step 1 and 2 | Participants who receive both Step 1 and Step 2 of speciliased CBT for tinnitus. Receives: Behavioral: CBT 1; Behavioral: CBT 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Utilities Index-III
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.
Measured: 12 months
Secondary outcomes (6)
Tinnitus Handicap Inventory (THI)
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.
Measured: 12 months
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983).
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").
Measured: 12 months
Tinnitus Catastrophizing Scale (TCS)
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.
Measured: 12 months
Fear of Tinnitus Questionnaire (FTQ)
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.
Measured: 12 months
Tinnitus Questionnaire (TQ)
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.
Measured: 12 months
Tinnitus Disability Index (TDI)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Jan 2014
- Primary completion16 Nov 2016
- Study completion16 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- SWOL Limburgs Fonds voor Revalidatie, Flemish Government, Belgium, The Netherlands Organization for Scientific Research (NWO), Libra Revalidatie en Audiologie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310605
- Sponsor's protocol ID
- ECP-152 05_12_2014
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3.
PubMed 22633033
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behaviour Therapy (CBT) for Tinnitus Treatment: Implementation and Validity
- ClinicalTrials.gov ID
- NCT04310605
- Acronym / sponsor ID
- ECP-152 05_12_2014
- Conditions
- Tinnitus, Subjective
- Keywords
- tinnitus, CBT, cognitive behaviour therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- SWOL Limburgs Fonds voor Revalidatie, Flemish Government, Belgium, The Netherlands Organization for Scientific Research (NWO), Libra Revalidatie en Audiologie
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 16 Nov 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study of specialised CBT for tinnitus for adults delivered in routine care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step 1 only | – | Behavioral: CBT 1Participants in the study who only receive Step 1 of specialised CBT |
| Step 1 and 2 | – | Behavioral: CBT 1, Behavioral: CBT 2Participants who receive both Step 1 and Step 2 of speciliased CBT for tinnitus. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with tinnitus
Key inclusion criteria (2 listed)
- Tinnitus is the primary complaint and reason for seeking help
- Participant is at least 17 years of age,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT 1CBT 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). | Behavioural | Step 1 and 2, Step 1 only |
| CBT 2Step 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. | Behavioural | Step 1 and 2 |
Primary outcome
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.
6 secondary outcomes
Tinnitus Handicap Inventory (THI)
Time frame: 12 months
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983).
Time frame: 12 months
Tinnitus Catastrophizing Scale (TCS)
Time frame: 12 months
Fear of Tinnitus Questionnaire (FTQ)
Time frame: 12 months
Tinnitus Questionnaire (TQ)
Time frame: 12 months
Tinnitus Disability Index (TDI)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 22633033Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, Subjective, run by Maastricht University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Utilities Index-III (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04310605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.