Internet-based Guided Self-help for Chronic Tinnitus (TITUS)
|ClinicalTrials.gov Identifier: NCT01205919|
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : April 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Behavioral: Internet-based guided self-help for tinnitus Other: Internet discussion forum||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of an Internet-based Guided Self-help Training for Chronic Tinnitus: A Randomized Controlled Trial|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2011|
Experimental: Internet-based 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.
Behavioral: Internet-based guided self-help for tinnitus
Internet-based guided self-help for tinnitus: provided via Internet, duration of 10 weeks
Active Comparator: Discussion forum group
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.
Other: Internet discussion forum
Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)
- Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007) [ Time Frame: 18 months ]The measure assesses tinnitus-related disability and handicap.
- MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004) [ Time Frame: 18 months ]The measure is a short version of the Tinnitus Questionnaire (TQ, Goebel & Hiller, 1998), to assess tinnitus-related psychological distress.
- Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005) [ Time Frame: 18 months ]The measure assesses depression and anxiety.
- Insomnia Severity Index (ISI; Bastien, Vallière, & Morin, 2001; German version: Pillmann, 2004) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 18 months ]The measure assesses the fear of anxiety-related sensations.
- Fear Avoidance Questionnaire (FAQ; self-developed) [ Time Frame: 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) [ Time Frame: 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).
- Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus) [ Time Frame: 6 months ]The scale assesses treatment credibility.
- Therapy Expectancy Scale (self-developed) [ Time Frame: baseline ]The scale assesses treatment expectancy.
- Therapy Satisfaction Scale (self-developed) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 18 months ]The measure assesses psychological acceptance of the tinnitus.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205919
|Department of Behavioural Sciences and Learning, Linkoeping University|
|Linköping, Sweden, SE-58183|
|Study Chair:||Gerhard Andersson, Ph.D.||Linkoeping University|
|Principal Investigator:||Cornelia Weise, Ph.D.||Linkoeping University|