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

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Internet-based guided self-help for tinnitus
Cognitive-behavior group therapy for tinnitus
Internet discussion forum
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Internet Training, Cognitive-Behavior Therapy, CBT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Psychology and Psychotherapy, Johannes Gutenberg University Mainz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Internet-based guided self-help

Cognitive-behavior group therapy

Discussion forum group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007)
The measure assesses tinnitus-related disability and handicap.
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

Secondary Outcome Measures

Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005)
The measure assesses depression and anxiety.
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).
Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)
The measure assesses dysfunctional beliefs and cognitions regarding the tinnitus.
Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)
The measure assesses psychological acceptance of the tinnitus.
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.
Fear Avoidance Questionnaire (FAQ; self-developed measure)
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)
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)
The scale assesses treatment credibility.
Therapy Expectancy Scale (self-developed)
The scale assesses therapy expectancy.
Therapy Satisfaction Scale (self-developed)
The scale assesses treatment satisfaction.
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.
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.
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.

Full Information

First Posted
September 17, 2010
Last Updated
April 1, 2014
Sponsor
Johannes Gutenberg University Mainz
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01205906
Brief Title
Comparison of an Internet-based Guided Self-help and a Group Therapy for Chronic Tinnitus
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
Collaborators
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, Internet Training, Cognitive-Behavior Therapy, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based guided self-help
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive-behavior group therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Discussion forum group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based guided self-help for tinnitus
Intervention Description
Internet-based self-help for tinnitus: provided via Internet, duration of 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavior group therapy for tinnitus
Intervention Description
Cognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, duration of 10 weeks
Intervention Type
Other
Intervention Name(s)
Internet discussion forum
Intervention Description
Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007)
Description
The measure assesses tinnitus-related disability and handicap.
Time Frame
18 months
Title
MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004)
Description
The measure is a short version of the Tinnitus Questionnaire (TQ, Goebel & Hiller, 1998), to assess tinnitus-related psychological distress
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005)
Description
The measure assesses depression and anxiety.
Time Frame
18 months
Title
Insomnia Severity Index (ISI; Bastien, Vallière, & Morin, 2001; German version: Pillmann, 2004)
Description
The measure assesses the quality of sleep (sleep duration, sleep quality and negative impact on daily functioning).
Time Frame
18 months
Title
Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)
Description
The measure assesses dysfunctional beliefs and cognitions regarding the tinnitus.
Time Frame
18 months
Title
Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)
Description
The measure assesses psychological acceptance of the tinnitus.
Time Frame
18 months
Title
Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007; German version: Kemper, Ziegler, & Taylor, 2007)
Description
The measure assesses the fear of anxiety-related sensations.
Time Frame
18 months
Title
Fear Avoidance Questionnaire (FAQ; self-developed measure)
Description
The measure assesses fear-avoidance beliefs and behavior.
Time Frame
18 months
Title
Working Alliance Inventory - Short Revised (WAI-SR; Horvath & Greenberg, 1986, 1989; German version: Wilmers et al., 2008)
Description
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).
Time Frame
2 months
Title
Credibility Scale (Devilly & Borkovec, 2000; self-translated and adapted to an intervention for tinnitus)
Description
The scale assesses treatment credibility.
Time Frame
6 months
Title
Therapy Expectancy Scale (self-developed)
Description
The scale assesses therapy expectancy.
Time Frame
baseline
Title
Therapy Satisfaction Scale (self-developed)
Description
The scale assesses treatment satisfaction.
Time Frame
week 10
Title
Web Screening Questionnaire for Common Mental Disorders (WSQ; Donker, van Straten, Marks, & Cuijpers, 2009; self-translated German version)
Description
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.
Time Frame
3 months
Title
Big Five Inventory (BFI-10; Rammstedt & John, 2007; German version: Rammstedt & John, 2007)
Description
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.
Time Frame
baseline
Title
Process evaluation items (self-developed)
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Hiller, Ph.D.
Organizational Affiliation
Johannes Gutenberg University Mainz
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Kleinstäuber, Ph.D.
Organizational Affiliation
Johannes Gutenberg University Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Psychology and Psychotherapy, Johannes Gutenberg University Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
D-55122
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
12271112
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.
Results Reference
background
PubMed Identifier
15865915
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.
Results Reference
background
PubMed Identifier
17662757
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.
Results Reference
background
PubMed Identifier
19027431
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.
Results Reference
background
Links:
URL
http://www.kbt.info/mint/tinnitus.php
Description
Study registration website

Learn more about this trial

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

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