AzTrials
AzTrials

TinnitusTITUSNCT01205919

Internet-based Guided Self-help for Chronic Tinnitus

A study testing Internet-based guided self-help for tinnitus and Internet discussion forum in people with Tinnitus, run by Johannes Gutenberg University Mainz at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the efficacy of a cognitive behavioral guided self-help training provided via the internet on tinnitus distress in a German sample. 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 and Internet discussion forum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteSweden
Study dates
May 2010to Oct 2011
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 38 or above on the Tinnitus Handicap Inventory (THI) or scoring 13 or above on the Mini-Tinnitus Questionnaire (Mini-TQ)
  • Not currently receiving psychological treatment for tinnitus
  • Being able to access the Internet and print instructions
  • Sufficient knowledge of the German language to read and follow the Internet-based self-help program

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.

Sweden1 site

  • Department of Behavioural Sciences and Learning, Linkoeping University

    Linköping, SE-58183

Other trials in Sweden

About this study

Official title: Efficacy of an Internet-based Guided Self-help Training for Chronic Tinnitus: A Randomized Controlled Trial

The purpose of this study is to determine the efficacy of a cognitive behavioral guided self-help training provided via the internet on tinnitus distress in a German sample.

Read the detailed description

Long waiting periods and the deficiency of outpatient therapies stimulated the development of internet-based interventions for a variety of mental disorders during the last years. A Swedish research group developed an internet-based self-help training for patients with chronic tinnitus showing promising results (Andersson et al., 2002; Kaldo et al., 2007; Kaldo et al., 2008). This self-help training was now adapted for German-speaking patients. The present study evaluates the efficacy of this treatment in a randomized controlled trial conducted in Germany. Further aims are a process evaluation of the treatment and the identification of predictors of efficacy.

Conditions
Tinnitus
Being tested
Internet-based guided self-help 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 guided self-help for tinnitus: provided via Internet, duration of 10 weeks

  • Internet discussion forumOther

    Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)

Study groups in NCT01205919
Study groupRoleWhat they receive
Internet-based self-helpExperimentalThis 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
Discussion forum groupActive comparatorTo the participants of the control group 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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)

    The measure assesses dysfunctional beliefs and cognitions regarding the tinnitus.

    Measured: 18 months

  4. 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

  5. Fear Avoidance Questionnaire (FAQ; self-developed)

    The measure assesses fear-avoidance beliefs and behavior.

    Measured: 18 months

  6. 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

  7. Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)

    The scale assesses treatment credibility.

    Measured: 6 months

  8. Therapy Expectancy Scale (self-developed)

    The scale assesses treatment expectancy.

    Measured: baseline

  9. Therapy Satisfaction Scale (self-developed)

    The scale assesses treatment satisfaction.

    Measured: week 10

  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

  11. 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

  12. Process evaluation items (self-developed)

    10 items assess 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

  13. Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)

    The measure assesses psychological acceptance of the tinnitus.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionOct 2010
  4. Study completionOct 2011

Resources

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
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01205919
Sponsor's protocol ID
TITUS-110510
Acronym
TITUS
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 12271112

  • Kaldo 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 17662757

  • Kaldo 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

  • Weise C, Kleinstauber M, Andersson G. Internet-Delivered Cognitive-Behavior Therapy for Tinnitus: A Randomized Controlled Trial. Psychosom Med. 2016 May;78(4):501-10. doi: 10.1097/PSY.0000000000000310.

    PubMed 26867083

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based guided self-help for tinnitus and Internet discussion forum in people with Tinnitus, run by Johannes Gutenberg University Mainz at 1 site in Sweden.

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 7 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 Sweden. 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 NCT01205919, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in