Internet-based Guided Self-help for Chronic Tinnitus (TITUS)

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Tinnitus

Treatments: Other: Internet discussion forum; Behavioral: Internet-based guided self-help for tinnitus

Study type: Interventional

Funder types: Other

Identifiers

NCT01205919

TITUS-110510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

124 participants in 2 patient groups

Internet-based self-help

Experimental group

Description:

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.

Treatment:

Behavioral: Internet-based guided self-help for tinnitus

Discussion forum group

Active Comparator group

Description:

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.

Treatment:

Other: Internet discussion forum