TinnitusMINTNCT01205906
Comparison of an Internet-based Guided Self-help and a Group Therapy for Chronic Tinnitus
A study testing Internet-based guided self-help for tinnitus, Cognitive-behavior group therapy for tinnitus and Internet discussion forum in people with Tinnitus, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The aim of this study is to compare the efficacy of an internet-based guided self-help training for chronic tinnitus with a well-established outpatient group therapy and a discussion forum group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Internet-based guided self-help for tinnitus, Cognitive-behavior group therapy for tinnitus and Internet discussion forum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Mar 2012
- 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
- Age of at least 18 years
- Chronic tinnitus for at least 6 months
- Medical examination of tinnitus by an ear, nose and throat physician (ENT)
- Scoring 18 or above on the Tinnitus Handicap Inventory (THI) or scoring 12 or above in the Mini-Tinnitus Questionnaire (Mini-TQ)
- Not currently receiving psychological treatment for tinnitus
- Being able to access the Internet and print instructions
Show all 9Show fewer
- Sufficient knowledge of the German language to read and follow the internet-based self-help training
- Being able to attend weekly group sessions in the Outpatient Department of the Psychological Institute of the University of Mainz, Germany
- Sufficient time and motivation to work on the treatment programs
Who cannot join
- Tinnitus caused by any other general medical condition or otologic disease (e.g., active Meniere's Disease)
- Clinical diagnosis of any severe mental disorder (especially a severe depressive disorder, suicidality, acute psychosis)
- Clinical diagnosis of Dementia or another severe organic cerebral disorder
- Clinical diagnosis of substance-related addiction/abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Psychology and Psychotherapy, Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, D-55122
About this study
Official title: Comparison of the Efficacy of an Internet-based Self-help Training and a Well-established Outpatient Group Therapy for the Treatment of Chronic Tinnitus: A Randomized Controlled Trial
The aim of this study is to compare the efficacy of an internet-based guided self-help training for chronic tinnitus with a well-established outpatient group therapy and a discussion forum group.
Read the detailed description
Chronic tinnitus can result in significant psychological suffering and reduce quality of life. Cognitive behavioral therapy (CBT) has been shown to be effective in decreasing the impairment caused by tinnitus. One recent way delivering CBT is an internet-based self-help intervention. Internet interventions for patients with chronic tinnitus, developed by Swedish scientists, showed promising results (Andersson et al., 2002; Kaldo et al., 2007; Kaldo et al., 2008). The main purpose of this study is to compare the efficacy of this internet-based self-help training for chronic tinnitus with a traditional well-established CBT group treatment and with a discussion forum group in a randomized controlled trial. Secondary goals are a process evaluation of both treatments, the identification of predictors of treatment success, an estimation of the cost-effectiveness of each treatment and the validation of the Tinnitus Cognitions Questionnaire (T-Cog; Hiller \& Haerkötter, 2005).
- Conditions
- Tinnitus
- Being tested
- Internet-based guided self-help for tinnitus, Cognitive-behavior group therapy for tinnitus, Internet discussion forum
- Keywords
- Tinnitus, Internet Training, Cognitive-Behavior Therapy, CBT
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based guided self-help for tinnitusBehavioural
Internet-based self-help for tinnitus: provided via Internet, duration of 10 weeks
Cognitive-behavior group therapy for tinnitusBehavioural
Cognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, duration of 10 weeks
Internet discussion forumOther
Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)
| Study group | Role | What they receive |
|---|---|---|
| Internet-based guided self-help | Experimental | This self-help training is exclusively provided via Internet over a period of 10 weeks. The treatment is based on the cognitive-behavioral approach and consists of 18 modules with helpful strategies to cope with tinnitus (e.g., applied relaxation, positive imagery, attention shift exercises, cognitive restructuring, sleep management, concentration management,). All modules include an information text, detailed practice instructions, worksheets and homework assignments. At the end of each treatment week, there is an e-mail contact between the participants and their therapist. The participants report on their work with the modules and if they had encountered any problems. The therapist provides feedback, support and recommendations on how to proceed. Receives: Behavioral: Internet-based guided self-help for tinnitus |
| Cognitive-behavior group therapy | Experimental | This well-established, cognitive-behavior group therapy was developed by Hiller and Haerkötter (2005) and consists of 10 weekly group sessions of 90 minutes. The strictly manualized program includes the following components focusing on the special needs of chronic tinnitus patients: Education, relaxation techniques, cognitive restructuring, the role of attentional processes for tinnitus perception, analysis of avoidance behaviors, tinnitus and the health care system as well as relapse prevention. For each session participants receive written materials, exercises and homework assignments to enhance understanding and to transfer the new information into the daily routine. Receives: Behavioral: Cognitive-behavior group therapy for tinnitus |
| Discussion forum group | Active comparator | To the participants of the control group the group therapy or the internet-based self-help after waiting time of 10 weeks is offered. During the waiting period participants receive access to a tinnitus online discussion forum. Receives: Other: Internet discussion forum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007)
The measure assesses tinnitus-related disability and handicap.
Measured: 18 months
MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004)
The measure is a short version of the Tinnitus Questionnaire (TQ, Goebel \& Hiller, 1998), to assess tinnitus-related psychological distress
Measured: 18 months
Secondary outcomes (13)
Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005)
The measure assesses depression and anxiety.
Measured: 18 months
Insomnia Severity Index (ISI; Bastien, Vallière, & Morin, 2001; German version: Pillmann, 2004)
The measure assesses the quality of sleep (sleep duration, sleep quality and negative impact on daily functioning).
Measured: 18 months
Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)
The measure assesses dysfunctional beliefs and cognitions regarding the tinnitus.
Measured: 18 months
Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)
The measure assesses psychological acceptance of the tinnitus.
Measured: 18 months
Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007; German version: Kemper, Ziegler, & Taylor, 2007)
The measure assesses the fear of anxiety-related sensations.
Measured: 18 months
Fear Avoidance Questionnaire (FAQ; self-developed measure)
The measure assesses fear-avoidance beliefs and behavior.
Measured: 18 months
Working Alliance Inventory - Short Revised (WAI-SR; Horvath & Greenberg, 1986, 1989; German version: Wilmers et al., 2008)
The measure assesses three aspects of the therapeutic alliance (development of an affective bond, agreement on the tasks of therapy and agreement on the goals of therapy).
Measured: 2 months
Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)
The scale assesses treatment credibility.
Measured: 6 months
Therapy Expectancy Scale (self-developed)
The scale assesses therapy expectancy.
Measured: baseline
Therapy Satisfaction Scale (self-developed)
The scale assesses treatment satisfaction.
Measured: week 10
Web Screening Questionnaire for Common Mental Disorders (WSQ; Donker, van Straten, Marks, & Cuijpers, 2009; self-translated German version)
The questionnaire screens for depressive disorder, alcohol abuse/dependence, generalized anxiety disorder, posttraumatic stress disorder, social phobia, panic disorder, agoraphobia, specific phobia, and obsessive-compulsive disorder.
Measured: 3 months
Big Five Inventory (BFI-10; Rammstedt & John, 2007; German version: Rammstedt & John, 2007)
The measure is the short version of the Big Five Inventory (BFI; John, Donahue, \& Kentle, 1991) and assesses the five personality traits extraversion, agreeableness, conscientiousness, neuroticism, and openness.
Measured: baseline
Process evaluation items (self-developed)
10 items assessing tinnitus loudness, tinnitus annoyance, perceived control, general mood, tinnitus acceptance, social functioning, behavioral avoidance and fear of sounds as well as the use of learned methods during the last week.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Maria Kleinstäuber, Johannes Gutenberg University Mainz
- Investigators
- Wolfgang Hiller, Ph.D., Study chair, Johannes Gutenberg University MainzMaria Kleinstäuber, Ph.D., Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205906
- Sponsor's protocol ID
- MINT-100510
- Acronym
- MINT
- Status last verified
- Apr 2014
- First submitted
- 17 Sep 2010
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersson G, Stromgren T, Strom L, Lyttkens L. Randomized controlled trial of internet-based cognitive behavior therapy for distress associated with tinnitus. Psychosom Med. 2002 Sep-Oct;64(5):810-6. doi: 10.1097/01.psy.0000031577.42041.f8.
PubMed 12271112Hiller W, Haerkotter C. Does sound stimulation have additive effects on cognitive-behavioral treatment of chronic tinnitus? Behav Res Ther. 2005 May;43(5):595-612. doi: 10.1016/j.brat.2004.03.012.
PubMed 15865915Kaldo V, Cars S, Rahnert M, Larsen HC, Andersson G. Use of a self-help book with weekly therapist contact to reduce tinnitus distress: a randomized controlled trial. J Psychosom Res. 2007 Aug;63(2):195-202. doi: 10.1016/j.jpsychores.2007.04.007.
PubMed 17662757Kaldo V, Levin S, Widarsson J, Buhrman M, Larsen HC, Andersson G. Internet versus group cognitive-behavioral treatment of distress associated with tinnitus: a randomized controlled trial. Behav Ther. 2008 Dec;39(4):348-59. doi: 10.1016/j.beth.2007.10.003. Epub 2008 Apr 20.
PubMed 19027431
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of an Internet-based Self-help Training and a Well-established Outpatient Group Therapy for the Treatment of Chronic Tinnitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01205906
- Acronym / sponsor ID
- MINT / MINT-100510
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Internet Training, Cognitive-Behavior Therapy, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- May 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Sep 2010 (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.
The aim of this study is to compare the efficacy of an internet-based guided self-help training for chronic tinnitus with a well-established outpatient group therapy and a discussion forum group.
Detailed description
Chronic tinnitus can result in significant psychological suffering and reduce quality of life. Cognitive behavioral therapy (CBT) has been shown to be effective in decreasing the impairment caused by tinnitus. One recent way delivering CBT is an internet-based self-help intervention. Internet interventions for patients with chronic tinnitus, developed by Swedish scientists, showed promising results (Andersson et al., 2002; Kaldo et al., 2007; Kaldo et al., 2008). The main purpose of this study is to compare the efficacy of this internet-based self-help training for chronic tinnitus with a traditional well-established CBT group treatment and with a discussion forum group in a randomized controlled trial. Secondary goals are a process evaluation of both treatments, the identification of predictors of treatment success, an estimation of the cost-effectiveness of each treatment and the validation of the Tinnitus Cognitions Questionnaire (T-Cog; Hiller \& Haerkötter, 2005).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet-based guided self-help | Experimental | Behavioral: Internet-based guided self-help for tinnitusThis self-help training is exclusively provided via Internet over a period of 10 weeks. The treatment is based on the cognitive-behavioral approach and consists of 18 modules with helpful strategies to cope with tinnitus (e.g., applied relaxation, positive imagery, attention shift exercises, cognitive restructuring, sleep management, concentration management,). All modules include an information text, detailed practice instructions, worksheets and homework assignments. At the end of each treatment week, there is an e-mail contact between the participants and their therapist. The participants report on their work with the modules and if they had encountered any problems. The therapist provides feedback, support and recommendations on how to proceed. |
| Cognitive-behavior group therapy | Experimental | Behavioral: Cognitive-behavior group therapy for tinnitusThis well-established, cognitive-behavior group therapy was developed by Hiller and Haerkötter (2005) and consists of 10 weekly group sessions of 90 minutes. The strictly manualized program includes the following components focusing on the special needs of chronic tinnitus patients: Education, relaxation techniques, cognitive restructuring, the role of attentional processes for tinnitus perception, analysis of avoidance behaviors, tinnitus and the health care system as well as relapse prevention. For each session participants receive written materials, exercises and homework assignments to enhance understanding and to transfer the new information into the daily routine. |
| Discussion forum group | Active comparator | Other: Internet discussion forumTo the participants of the control group the group therapy or the internet-based self-help after waiting time of 10 weeks is offered. During the waiting period participants receive access to a tinnitus online discussion forum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of at least 18 years
- Chronic tinnitus for at least 6 months
- Medical examination of tinnitus by an ear, nose and throat physician (ENT)
- Scoring 18 or above on the Tinnitus Handicap Inventory (THI) or scoring 12 or above in the Mini-Tinnitus Questionnaire (Mini-TQ)
- Not currently receiving psychological treatment for tinnitus
Key exclusion criteria (4 listed)
- Tinnitus caused by any other general medical condition or otologic disease (e.g., active Meniere's Disease)
- Clinical diagnosis of any severe mental disorder (especially a severe depressive disorder, suicidality, acute psychosis)
- Clinical diagnosis of Dementia or another severe organic cerebral disorder
- Clinical diagnosis of substance-related addiction/abuse
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 |
|---|---|---|
| Internet-based guided self-help for tinnitusInternet-based self-help for tinnitus: provided via Internet, duration of 10 weeks | Behavioural | Internet-based guided self-help |
| Cognitive-behavior group therapy for tinnitusCognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, duration of 10 weeks | Behavioural | Cognitive-behavior group therapy |
| Internet discussion forumTinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention) | Other | Discussion forum group |
Primary outcome
Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007)
Time frame: 18 months
The measure assesses tinnitus-related disability and handicap.
MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004)
Time frame: 18 months
The measure is a short version of the Tinnitus Questionnaire (TQ, Goebel \& Hiller, 1998), to assess tinnitus-related psychological distress
13 secondary outcomes
Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005)
Time frame: 18 months
Insomnia Severity Index (ISI; Bastien, Vallière, & Morin, 2001; German version: Pillmann, 2004)
Time frame: 18 months
Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)
Time frame: 18 months
Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)
Time frame: 18 months
Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007; German version: Kemper, Ziegler, & Taylor, 2007)
Time frame: 18 months
Fear Avoidance Questionnaire (FAQ; self-developed measure)
Time frame: 18 months
Working Alliance Inventory - Short Revised (WAI-SR; Horvath & Greenberg, 1986, 1989; German version: Wilmers et al., 2008)
Time frame: 2 months
Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)
Time frame: 6 months
Therapy Expectancy Scale (self-developed)
Time frame: baseline
Therapy Satisfaction Scale (self-developed)
Time frame: week 10
Web Screening Questionnaire for Common Mental Disorders (WSQ; Donker, van Straten, Marks, & Cuijpers, 2009; self-translated German version)
Time frame: 3 months
Big Five Inventory (BFI-10; Rammstedt & John, 2007; German version: Rammstedt & John, 2007)
Time frame: baseline
Process evaluation items (self-developed)
Time frame: 18 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 3 Apr 2014.
- Background: PubMed 12271112Andersson G, Stromgren T, Strom L, Lyttkens L. Randomized controlled trial of internet-based cognitive behavior therapy for distress associated with tinnitus. Psychosom Med. 2002 Sep-Oct;64(5):810-6. doi: 10.1097/01.psy.0000031577.42041.f8.
- Background: PubMed 15865915Hiller W, Haerkotter C. Does sound stimulation have additive effects on cognitive-behavioral treatment of chronic tinnitus? Behav Res Ther. 2005 May;43(5):595-612. doi: 10.1016/j.brat.2004.03.012.
- Background: PubMed 17662757Kaldo V, Cars S, Rahnert M, Larsen HC, Andersson G. Use of a self-help book with weekly therapist contact to reduce tinnitus distress: a randomized controlled trial. J Psychosom Res. 2007 Aug;63(2):195-202. doi: 10.1016/j.jpsychores.2007.04.007.
- Background: PubMed 19027431Kaldo V, Levin S, Widarsson J, Buhrman M, Larsen HC, Andersson G. Internet versus group cognitive-behavioral treatment of distress associated with tinnitus: a randomized controlled trial. Behav Ther. 2008 Dec;39(4):348-59. doi: 10.1016/j.beth.2007.10.003. Epub 2008 Apr 20.
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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.
Wolfgang Hiller, Ph.D. study chair
Johannes Gutenberg University Mainz
Maria Kleinstäuber, Ph.D. principal investigator
Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based guided self-help for tinnitus, Cognitive-behavior group therapy for tinnitus and Internet discussion forum in people with Tinnitus, run by Johannes Gutenberg University Mainz 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 9 inclusion and 4 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 3 Apr 2014. 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?
Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007) (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT01205906, which also lists 4 linked publications.
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 3 Apr 2014.