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
• Sponsor: Johannes Gutenberg University Mainz
• Collaborator: Linkoeping University
• Information provided by (Responsible Party): Cornelia Weise, Linkoeping University

Tracking Information

• First Submitted Date: September 17, 2010
• First Posted Date: September 21, 2010
• Last Update Posted Date: April 3, 2014
• Study Start Date: May 2010
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 20, 2010)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 2, 2014)

• 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.

Original Secondary Outcome Measures (submitted: September 20, 2010)

• 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, GAD, PTSD, social phobia, panic disorder, agoraphobia, specific phobia, and OCD.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Tinnitus

Intervention

• Behavioral: Internet-based guided self-help for tinnitus
  Internet-based guided self-help for tinnitus: provided via Internet, duration of 10 weeks
• Other: Internet discussion forum
  Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)

Study Arms

• 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.
  Intervention: Behavioral: Internet-based guided self-help for tinnitus
• 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.
  Intervention: Other: Internet discussion forum

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 2, 2014): 124
• Original Estimated Enrollment (submitted: September 20, 2010): 120
• Actual Study Completion Date: October 2011
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT01205919
• Other Study ID Numbers: TITUS-110510
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Cornelia Weise, Linkoeping University
• Original Responsible Party: Cornelia Weise, Ph.D., Linkoeping University, Department of Behavioural Sciences and Learning
• Current Study Sponsor: Johannes Gutenberg University Mainz
• Original Study Sponsor: Same as current
• Collaborators: Linkoeping University

Investigators

• Study Chair: Gerhard Andersson, Ph.D.; Linkoeping University
• Principal Investigator: Cornelia Weise, Ph.D.; Linkoeping University

• PRS Account: Johannes Gutenberg University Mainz
• Verification Date: April 2014