Internet-based Guided Self-help for Chronic Tinnitus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tinnitus

Intervention / Treatment
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* Behavioral: Internet-based guided self-help for tinnitus
* Other: Internet discussion forum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based self-help<br>This 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. | Behavioral: Internet-based guided self-help for tinnitus<br>* Internet-based guided self-help for tinnitus: provided via Internet, duration of 10 weeks<br>|
| Active Comparator: Discussion forum group<br>To 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. | Other: Internet discussion forum<br>* Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007) | The measure assesses tinnitus-related disability and handicap. | 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005) | The measure assesses depression and anxiety. | 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). | 18 months | 
| Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005) | The measure assesses dysfunctional beliefs and cognitions regarding the tinnitus. | 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. | 18 months | 
| Fear Avoidance Questionnaire (FAQ; self-developed) | The measure assesses fear-avoidance beliefs and behavior. | 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). | 2 months | 
| Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus) | The scale assesses treatment credibility. | 6 months | 
| Therapy Expectancy Scale (self-developed) | The scale assesses treatment expectancy. | baseline | 
| Therapy Satisfaction Scale (self-developed) | The scale assesses treatment satisfaction. | 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. | 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. | baseline | 
| 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. | 18 months | 
| Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated) | The measure assesses psychological acceptance of the tinnitus. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinnitus, Internet Training, Cognitive-Behavior Therapy, CBT