Internet-based Guided Self-help for Chronic Tinnitus

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Behavioral: Internet-based guided self-help for tinnitus; Other: Internet discussion forum

• Registration Number: NCT01205919
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Primary Completion: 2010-10
• Study Completion: 2011-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Internet-based self-help	Internet-based guided self-help for tinnitus	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.
Discussion forum group	Internet discussion forum	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)	6 months	The scale assesses treatment credibility.
Therapy Expectancy Scale (self-developed)	baseline	The scale assesses treatment expectancy.
Therapy Satisfaction Scale (self-developed)	week 10	The scale assesses treatment satisfaction.
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.
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.
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).

Trial Locations

Locations (1)

Department of Behavioural Sciences and Learning, Linkoeping University; 🇸🇪 Linköping, Sweden