Tinnitus
Conditions
Keywords
Tinnitus, Internet Training, Cognitive-Behavior Therapy, CBT
Brief 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.
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.
Interventions
Internet-based guided self-help for tinnitus: provided via Internet, duration of 10 weeks
Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)
Sponsors
Linkoeping University
Johannes Gutenberg University Mainz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007) | 18 months | The measure assesses tinnitus-related disability and handicap. |
| MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004) | 18 months | The measure is a short version of the Tinnitus Questionnaire (TQ, Goebel & Hiller, 1998), to assess tinnitus-related psychological distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI; Bastien, Vallière, & Morin, 2001; German version: Pillmann, 2004) | 18 months | The measure assesses the quality of sleep (sleep duration, sleep quality and negative impact on daily functioning). |
| Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005) | 18 months | The measure assesses dysfunctional beliefs and cognitions regarding the tinnitus. |
| Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007; German version: Kemper, Ziegler, & Taylor, 2007) | 18 months | The measure assesses the fear of anxiety-related sensations. |
| Fear Avoidance Questionnaire (FAQ; self-developed) | 18 months | The measure assesses fear-avoidance beliefs and behavior. |
| Working Alliance Inventory - Short Revised (WAI-SR; Horvath & Greenberg, 1986, 1989; German version: Wilmers et al., 2008) | 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). |
| Therapy Satisfaction Scale (self-developed) | week 10 | The scale assesses treatment satisfaction. |
| Therapy Expectancy Scale (self-developed) | baseline | The scale assesses treatment expectancy. |
| Web Screening Questionnaire for Common Mental Disorders (WSQ; Donker, van Straten, Marks, & Cuijpers, 2009; self-translated German version) | 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. |
| Big Five Inventory (BFI-10; Rammstedt & John, 2007; German version: Rammstedt & John, 2007) | 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. |
| Process evaluation items (self-developed) | 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. |
| Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated) | 18 months | The measure assesses psychological acceptance of the tinnitus. |
| Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus) | 6 months | The scale assesses treatment credibility. |
| Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005) | 18 months | The measure assesses depression and anxiety. |
Countries
Sweden
Outcome results
None listed