Comparison of an Internet-based Guided Self-help and a Group Therapy for Chronic Tinnitus

Tinnitus Clinical Trial

— MINT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205906
• Other study ID #: MINT-100510
• Status: Completed
• Phase: N/A
• First received: September 17, 2010
• Last updated: April 1, 2014
• Start date: May 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2014
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Deutsche Gesellschaft für Psychologie (DGPs)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• Internet-based guided self-help for tinnitus
Internet-based self-help for tinnitus: provided via Internet, duration of 10 weeks
• Cognitive-behavior group therapy for tinnitus
Cognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, duration of 10 weeks

Other:
• Internet discussion forum
Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)

Locations

Country	Name	City	State
Germany	Department of Clinical Psychology and Psychotherapy, Johannes Gutenberg University Mainz	Mainz	Rheinland-Pfalz

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Linkoeping University

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Andersson G, Strömgren T, Ström 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. — View Citation

Hiller W, Haerkötter C. Does sound stimulation have additive effects on cognitive-behavioral treatment of chronic tinnitus? Behav Res Ther. 2005 May;43(5):595-612. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007)	The measure assesses tinnitus-related disability and handicap.	18 months	No
Primary	MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004)	The measure is a short version of the Tinnitus Questionnaire (TQ, Goebel & Hiller, 1998), to assess tinnitus-related psychological distress	18 months	No
Secondary	Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005)	The measure assesses depression and anxiety.	18 months	No
Secondary	Insomnia Severity Index (ISI; Bastien, Vallière, & Morin, 2001; German version: Pillmann, 2004)	The measure assesses the quality of sleep (sleep duration, sleep quality and negative impact on daily functioning).	18 months	No
Secondary	Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)	The measure assesses dysfunctional beliefs and cognitions regarding the tinnitus.	18 months	No
Secondary	Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)	The measure assesses psychological acceptance of the tinnitus.	18 months	No
Secondary	Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007; German version: Kemper, Ziegler, & Taylor, 2007)	The measure assesses the fear of anxiety-related sensations.	18 months	No
Secondary	Fear Avoidance Questionnaire (FAQ; self-developed measure)	The measure assesses fear-avoidance beliefs and behavior.	18 months	No
Secondary	Working Alliance Inventory - Short Revised (WAI-SR; Horvath & Greenberg, 1986, 1989; German version: Wilmers et al., 2008)	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).	2 months	No
Secondary	Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)	The scale assesses treatment credibility.	6 months	No
Secondary	Therapy Expectancy Scale (self-developed)	The scale assesses therapy expectancy.	baseline	No
Secondary	Therapy Satisfaction Scale (self-developed)	The scale assesses treatment satisfaction.	week 10	No
Secondary	Web Screening Questionnaire for Common Mental Disorders (WSQ; Donker, van Straten, Marks, & Cuijpers, 2009; self-translated German version)	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.	3 months	No
Secondary	Big Five Inventory (BFI-10; Rammstedt & John, 2007; German version: Rammstedt & John, 2007)	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.	baseline	No
Secondary	Process evaluation items (self-developed)	10 items assessing 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.	18 months	No

External Links

•   Study registration website