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

April 1, 2014 updated by: Maria Kleinstäuber, Johannes Gutenberg University Mainz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, D-55122
        • Department of Clinical Psychology and Psychotherapy, Johannes Gutenberg University Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-based guided 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 self-help for tinnitus: provided via Internet, duration of 10 weeks
Experimental: Cognitive-behavior group therapy
This well-established, cognitive-behavior group therapy was developed by Hiller and Haerkötter (2005) and consists of 10 weekly group sessions of 90 minutes. The strictly manualized program includes the following components focusing on the special needs of chronic tinnitus patients: Education, relaxation techniques, cognitive restructuring, the role of attentional processes for tinnitus perception, analysis of avoidance behaviors, tinnitus and the health care system as well as relapse prevention. For each session participants receive written materials, exercises and homework assignments to enhance understanding and to transfer the new information into the daily routine.
Behavioral: Cognitive-behavior group therapy for tinnitus
Cognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, duration of 10 weeks
Active Comparator: Discussion forum group
To the participants of the control group the group therapy or 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months
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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months
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).
18 months
Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)
Time Frame: 18 months
The measure assesses dysfunctional beliefs and cognitions regarding the tinnitus.
18 months
Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)
Time Frame: 18 months
The measure assesses psychological acceptance of the tinnitus.
18 months
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.
18 months
Fear Avoidance Questionnaire (FAQ; self-developed measure)
Time Frame: 18 months
The measure assesses fear-avoidance beliefs and behavior.
18 months
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).
2 months
Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)
Time Frame: 6 months
The scale assesses treatment credibility.
6 months
Therapy Expectancy Scale (self-developed)
Time Frame: baseline
The scale assesses therapy expectancy.
baseline
Therapy Satisfaction Scale (self-developed)
Time Frame: week 10
The scale assesses treatment satisfaction.
week 10
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.
3 months
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.
baseline
Process evaluation items (self-developed)
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Collaborators

Linkoeping University

Investigators

  • Study Chair: Wolfgang Hiller, Ph.D., Johannes Gutenberg University Mainz
  • Principal Investigator: Maria Kleinstäuber, Ph.D., Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 20, 2010

First Posted (Estimate)

September 21, 2010

Study Record Updates

Last Update Posted (Estimate)

April 3, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MINT-100510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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