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Completed

NCT Number: NCT01205919

Internet-based Guided Self-help for Chronic Tinnitus

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Behavioural Sciences and Learning, Linkoeping University

Linköping, SE-58183, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Internet-based guided self-help for tinnitus

Behavioral

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

Internet discussion forum

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005)

    Time frame: 18 months

    The measure assesses depression and anxiety.

  2. Insomnia Severity Index (ISI; Bastien, Vallière, & Morin, 2001; German version: Pillmann, 2004)

    Time frame: 18 months

    The measure assesses the quality of sleep (sleep duration, sleep quality and negative impact on daily functioning).

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

    Time frame: 18 months

    The measure assesses dysfunctional beliefs and cognitions regarding the tinnitus.

  4. Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007; German version: Kemper, Ziegler, & Taylor, 2007)

    Time frame: 18 months

    The measure assesses the fear of anxiety-related sensations.

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

    Time frame: 18 months

    The measure assesses fear-avoidance beliefs and behavior.

  6. Working Alliance Inventory - Short Revised (WAI-SR; Horvath & Greenberg, 1986, 1989; German version: Wilmers et al., 2008)

    Time frame: 2 months

    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).

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

    Time frame: 6 months

    The scale assesses treatment credibility.

  8. Therapy Expectancy Scale (self-developed)

    Time frame: baseline

    The scale assesses treatment expectancy.

  9. Therapy Satisfaction Scale (self-developed)

    Time frame: week 10

    The scale assesses treatment satisfaction.

  10. Web Screening Questionnaire for Common Mental Disorders (WSQ; Donker, van Straten, Marks, & Cuijpers, 2009; self-translated German version)

    Time frame: 3 months

    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.

  11. Big Five Inventory (BFI-10; Rammstedt & John, 2007; German version: Rammstedt & John, 2007)

    Time frame: baseline

    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.

  12. Process evaluation items (self-developed)

    Time frame: 18 months

    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.

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

    Time frame: 18 months

    The measure assesses psychological acceptance of the tinnitus.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

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

Acronym: TITUS

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Sep 21, 2010
Registry last updated
Apr 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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