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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Internet-based self-help for tinnitus: provided via Internet, duration of 10 weeks
Cognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, duration of 10 weeks
Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)
Department of Clinical Psychology and Psychotherapy, Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany
Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007)
The measure assesses tinnitus-related disability and handicap.
Time frame: 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
Time frame: 18 months
Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005)
The measure assesses depression and anxiety.
Time frame: 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).
Time frame: 18 months
Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)
The measure assesses dysfunctional beliefs and cognitions regarding the tinnitus.
Time frame: 18 months
Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)
The measure assesses psychological acceptance of the tinnitus.
Time frame: 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.
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Time frame: 18 months
Fear Avoidance Questionnaire (FAQ; self-developed measure)
The measure assesses fear-avoidance beliefs and behavior.
Time frame: 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).
Time frame: 2 months
Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)
The scale assesses treatment credibility.
Time frame: 6 months
Therapy Expectancy Scale (self-developed)
The scale assesses therapy expectancy.
Time frame: baseline
Therapy Satisfaction Scale (self-developed)
The scale assesses treatment satisfaction.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months