Clinical trial NCT01205906: Comparison of an Internet-based Guided Self-help and a Group Therapy for Chronic Tinnitus
Official title: Comparison of the Efficacy of an Internet-based Self-help Training and a Well-established Outpatient Group Therapy for the Treatment of 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: 128
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 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.

Detailed description: 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).

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 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

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: Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)
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 measure)
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
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Johannes Gutenberg University Mainz
state: Rheinland-Pfalz
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Wolfgang Hiller, Ph.D.
role: STUDY_CHAIR
affiliation: Johannes Gutenberg University Mainz
name: Maria Kleinstäuber, 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: Hiller W, Haerkotter C. Does sound stimulation have additive effects on cognitive-behavioral treatment of chronic tinnitus? Behav Res Ther. 2005 May;43(5):595-612. doi: 10.1016/j.brat.2004.03.012.
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.