Clinical trial NCT01205919: Internet-based Guided Self-help for Chronic Tinnitus
Official title: Efficacy of an Internet-based Guided Self-help Training for Chronic Tinnitus: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
Internet Training
Cognitive-Behavior Therapy
CBT
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2010-09-21
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007)
timeFrame: 18 months
measure: MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004)
timeFrame: 18 months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005)
timeFrame: 18 months
measure: Insomnia Severity Index (ISI; Bastien, Vallière, & Morin, 2001; German version: Pillmann, 2004)
timeFrame: 18 months
measure: Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)
timeFrame: 18 months
measure: Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007; German version: Kemper, Ziegler, & Taylor, 2007)
timeFrame: 18 months
measure: Fear Avoidance Questionnaire (FAQ; self-developed)
timeFrame: 18 months
measure: Working Alliance Inventory - Short Revised (WAI-SR; Horvath & Greenberg, 1986, 1989; German version: Wilmers et al., 2008)
timeFrame: 2 months
measure: Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)
timeFrame: 6 months
measure: Therapy Expectancy Scale (self-developed)
timeFrame: baseline
measure: Therapy Satisfaction Scale (self-developed)
timeFrame: week 10
measure: Web Screening Questionnaire for Common Mental Disorders (WSQ; Donker, van Straten, Marks, & Cuijpers, 2009; self-translated German version)
timeFrame: 3 months
measure: Big Five Inventory (BFI-10; Rammstedt & John, 2007; German version: Rammstedt & John, 2007)
timeFrame: baseline
measure: Process evaluation items (self-developed)
timeFrame: 18 months
measure: Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)
timeFrame: 18 months
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioural Sciences and Learning, Linkoeping University
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, Ph.D.
role: STUDY_CHAIR
affiliation: Linkoeping University
name: Cornelia Weise, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersson G, Stromgren T, Strom L, Lyttkens L. Randomized controlled trial of internet-based cognitive behavior therapy for distress associated with tinnitus. Psychosom Med. 2002 Sep-Oct;64(5):810-6. doi: 10.1097/01.psy.0000031577.42041.f8.
citation: Kaldo V, Cars S, Rahnert M, Larsen HC, Andersson G. Use of a self-help book with weekly therapist contact to reduce tinnitus distress: a randomized controlled trial. J Psychosom Res. 2007 Aug;63(2):195-202. doi: 10.1016/j.jpsychores.2007.04.007.
citation: Kaldo V, Levin S, Widarsson J, Buhrman M, Larsen HC, Andersson G. Internet versus group cognitive-behavioral treatment of distress associated with tinnitus: a randomized controlled trial. Behav Ther. 2008 Dec;39(4):348-59. doi: 10.1016/j.beth.2007.10.003. Epub 2008 Apr 20.
citation: Weise C, Kleinstauber M, Andersson G. Internet-Delivered Cognitive-Behavior Therapy for Tinnitus: A Randomized Controlled Trial. Psychosom Med. 2016 May;78(4):501-10. doi: 10.1097/PSY.0000000000000310.