TinnitusNCT01927991
Internet-based Self-help for Tinnitus: The Role of Support
A study testing iCBT (internet-based, cognitive-behavioural therapy) in people with Tinnitus, run by Philipps University Marburg at 1 site in Germany.
Trial summary
Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to provide psychotherapy. For several psychological and psychosomatic disorders, treatment efficacy was shown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- iCBT (internet-based, cognitive-behavioural therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to May 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- tinnitus duration of more than 6 months
- severe or most severe tinnitus distress
- age of at least 18 years
- fluent in German
Who cannot join
- psychosis, severe psychological disorder, risk for suicide
- prior participation in associated study
- medical disorder as reason for tinnitus, i.e. morbus ménière
Trial locations and contacts
1 site in 1 country.
Germany1 site
Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
Marburg, Hesse, 35037
About this study
Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to provide psychotherapy. For several psychological and psychosomatic disorders, treatment efficacy was shown. Previously, iCBT has also been applied to patients suffering from tinnitus and results show significant and long-term stable improvements in tinnitus distress. However, the role of therapeutic support in iCBT has not been thoroughly investigated. Previous results suggest that iCBT without therapeutic support is less effective and leads to higher dropout rates than therapist-guided iCBT. The aim of the randomized controlled trial is thus to investigate the role of therapeutic support in an iCBT for tinnitus sufferers.
- Conditions
- Tinnitus
- Being tested
- iCBT (internet-based, cognitive-behavioural therapy)
- Keywords
- tinnitus, cognitive behavioural therapy, internet treatment
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBT (internet-based, cognitive-behavioural therapy)Behavioural
The intervention is based on cognitive-behavioural therapy (CBT) and is offered as a self-help and provided over the internet. Participants work on their own on different modules which give information about tinnitus and the associated symptoms and provide instructions for practical exercises.
| Study group | Role | What they receive |
|---|---|---|
| iCBT with therapeutic support | Experimental | Participants work with the online self-help and receive additional therapeutic support on demand Receives: Behavioral: iCBT (internet-based, cognitive-behavioural therapy) |
| iCBT without therapeutic support | Active comparator | Participants work with the online self-help on their own and do not receive additional therapeutic support Receives: Behavioral: iCBT (internet-based, cognitive-behavioural therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tinnitus distress
Assessment of tinnitus distress with the Tinnitus Handicap Inventory (THI) and the Mini-Tinnitus Questionnaire (Mini-TQ)
Newman, C. W., Jacobson, G. P., \& Spitzer, J. B. (1996). Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg, 122(2), 143-148.
Hiller, W., \& Goebel, G. (2004). Rapid assessment of tinnitus-related psychological distress using the Mini-TQ. Int J Audiol, 43(10), 600-604.
Measured: 1 year; pre, post, 6-mo-follow-up
Secondary outcomes (3)
Change in depressive Symptoms
Assessment of depressive symptoms with the Patient Health Questionnaire (PHQ-9) and the Hospital Anxiety and Depression Scale (HADS)
Kroenke, K., Spitzer, R. L., \& Williams, J. B. W. (2001). The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med, 16(9), 606-613. 10.1046/j.1525-1497.2001.016009606.x
Zigmond, A. S., \& Snaith, R. P. (1983). The hospital anxiety and depression scale. Acta Psychiatr Scand, 67(6), 361-370.
Measured: 1 year; pre, post, 6mo-follow-up
Change in tinnitus-related thoughts
Assessment of dysfunctional tinnitus-related thoughts with the Tinnitus Cognitions Scale (T-Cog)
Hiller, W., \& Haerkötter, C. (2005). Does sound stimulation have additive effects on cognitive-behavioral treatment of chronic tinnitus? Behav Res Ther, 43(5), 595-612.
Measured: 1 year; pre, post, 6mo-follow-up
Change of tinnitus acceptance
Assessment of tinnitus acceptance with the Tinnitus Acceptance Questionnaire (TAQ)
Weise, C., Kleinstauber, M., Hesser, H., Westin, V. Z., \& Andersson, G. (2013). Acceptance of tinnitus: validation of the tinnitus acceptance questionnaire. Cognitive Behaviour Therapy, 42(2), 100-115. 10.1080/16506073.2013.781670
Measured: 1 year; pre, post, 6mo-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Cornelia Weise, Philipps University Marburg
- Investigators
- Cornelia Weise, Dr., Principal investigator, Philipps-University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927991
- Sponsor's protocol ID
- Titus2
- Status last verified
- Apr 2015
- First submitted
- 17 Aug 2013
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Self-help for Tinnitus: The Role of Support
- ClinicalTrials.gov ID
- NCT01927991
- Acronym / sponsor ID
- Titus2
- Conditions
- Tinnitus
- Keywords
- tinnitus, cognitive behavioural therapy, internet treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Aug 2013 (estimated)
- 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.
Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to provide psychotherapy. For several psychological and psychosomatic disorders, treatment efficacy was shown. Previously, iCBT has also been applied to patients suffering from tinnitus and results show significant and long-term stable improvements in tinnitus distress. However, the role of therapeutic support in iCBT has not been thoroughly investigated. Previous results suggest that iCBT without therapeutic support is less effective and leads to higher dropout rates than therapist-guided iCBT. The aim of the randomized controlled trial is thus to investigate the role of therapeutic support in an iCBT for tinnitus sufferers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCBT with therapeutic support | Experimental | Behavioral: iCBT (internet-based, cognitive-behavioural therapy)Participants work with the online self-help and receive additional therapeutic support on demand |
| iCBT without therapeutic support | Active comparator | Behavioral: iCBT (internet-based, cognitive-behavioural therapy)Participants work with the online self-help on their own and do not receive additional therapeutic support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- tinnitus duration of more than 6 months
- severe or most severe tinnitus distress
- age of at least 18 years
- fluent in German
Key exclusion criteria (3 listed)
- psychosis, severe psychological disorder, risk for suicide
- prior participation in associated study
- medical disorder as reason for tinnitus, i.e. morbus ménière
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 |
|---|---|---|
| iCBT (internet-based, cognitive-behavioural therapy)The intervention is based on cognitive-behavioural therapy (CBT) and is offered as a self-help and provided over the internet. Participants work on their own on different modules which give information about tinnitus and the associated symptoms and provide instructions for practical exercises. | Behavioural | iCBT with therapeutic support, iCBT without therapeutic support |
Primary outcome
Change in tinnitus distress
Time frame: 1 year; pre, post, 6-mo-follow-up
Assessment of tinnitus distress with the Tinnitus Handicap Inventory (THI) and the Mini-Tinnitus Questionnaire (Mini-TQ) Newman, C. W., Jacobson, G. P., \& Spitzer, J. B. (1996). Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg, 122(2), 143-148. Hiller, W., \& Goebel, G. (2004). Rapid assessment of tinnitus-related psychological distress using the Mini-TQ. Int J Audiol, 43(10), 600-604.
3 secondary outcomes
Change in depressive Symptoms
Time frame: 1 year; pre, post, 6mo-follow-up
Change in tinnitus-related thoughts
Time frame: 1 year; pre, post, 6mo-follow-up
Change of tinnitus acceptance
Time frame: 1 year; pre, post, 6mo-follow-up
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 28 Apr 2015.
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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.
Cornelia Weise, Dr. principal investigator
Philipps-University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT (internet-based, cognitive-behavioural therapy) in people with Tinnitus, run by Philipps University Marburg at 1 site in Germany.
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 4 inclusion and 3 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 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in tinnitus distress (time frame: 1 year; pre, post, 6-mo-follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2015.