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NCT Number: NCT01205906

Comparison of an Internet-based Guided Self-help and a Group Therapy for Chronic Tinnitus

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.

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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 Clinical Psychology and Psychotherapy, Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, D-55122, Germany

About this study

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).

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 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
  • 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

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

Cognitive-behavior group therapy for tinnitus

Behavioral

Cognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, 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. Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)

    Time frame: 18 months

    The measure assesses psychological acceptance of the tinnitus.

  5. 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.

  6. Fear Avoidance Questionnaire (FAQ; self-developed measure)

    Time frame: 18 months

    The measure assesses fear-avoidance beliefs and behavior.

  7. 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).

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

    Time frame: 6 months

    The scale assesses treatment credibility.

  9. Therapy Expectancy Scale (self-developed)

    Time frame: baseline

    The scale assesses therapy expectancy.

  10. Therapy Satisfaction Scale (self-developed)

    Time frame: week 10

    The scale assesses treatment satisfaction.

  11. 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.

  12. 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.

  13. Process evaluation items (self-developed)

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • Linkoeping University

Registry information

Official study 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

Acronym: MINT

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
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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