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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-03-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet-based guided self-help

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.

Group Type EXPERIMENTAL

Internet-based guided self-help for tinnitus

Intervention Type BEHAVIORAL

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

Cognitive-behavior group therapy

This well-established, cognitive-behavior group therapy was developed by Hiller and Haerkötter (2005) and consists of 10 weekly group sessions of 90 minutes. The strictly manualized program includes the following components focusing on the special needs of chronic tinnitus patients: Education, relaxation techniques, cognitive restructuring, the role of attentional processes for tinnitus perception, analysis of avoidance behaviors, tinnitus and the health care system as well as relapse prevention. For each session participants receive written materials, exercises and homework assignments to enhance understanding and to transfer the new information into the daily routine.

Group Type EXPERIMENTAL

Cognitive-behavior group therapy for tinnitus

Intervention Type BEHAVIORAL

Cognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, duration of 10 weeks

Discussion forum group

To the participants of the control group the group therapy or 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.

Group Type ACTIVE_COMPARATOR

Internet discussion forum

Intervention Type OTHER

Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)

Interventions

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Internet-based guided self-help for tinnitus

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

Intervention Type BEHAVIORAL

Cognitive-behavior group therapy for tinnitus

Cognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, duration of 10 weeks

Intervention Type BEHAVIORAL

Internet discussion forum

Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)

Intervention Type OTHER

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 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No