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

NCT01205906 | Completed

• 1 other identifier: MINT-100510
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

Tinnitus; Internet Training; Cognitive-Behavior Therapy; CBT

Outcome Measures

Primary Outcomes (2)

• Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007)

  The measure assesses tinnitus-related disability and handicap.

  18 months

• 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

Secondary Outcomes (13)

• Hospital Anxiety and Depression Scale (HADS-D; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss, & Snaith, 2005)

  18 months

• Insomnia Severity Index (ISI; Bastien, Vallière, & Morin, 2001; German version: Pillmann, 2004)

  18 months

• Tinnitus Cognitions Questionnaire (T-Cog; Hiller & Haerkötter, 2005)

  18 months

• Tinnitus Acceptance Questionnaire (TAQ; Westin, Hayes, & Andersson, 2008; self-translated)

  18 months

• Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007; German version: Kemper, Ziegler, & Taylor, 2007)

  18 months

Study Arms (3)

Internet-based guided self-help

EXPERIMENTAL

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

Cognitive-behavior group therapy

EXPERIMENTAL

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

Discussion forum group

ACTIVE COMPARATOR

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

Interventions

Internet-based guided self-help for tinnitus BEHAVIORAL

Internet-based self-help for tinnitus: provided via Internet, duration of 10 weeks

Internet-based guided self-help

Cognitive-behavior group therapy for tinnitus BEHAVIORAL

Cognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, duration of 10 weeks

Cognitive-behavior group therapy

Internet discussion forum OTHER

Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)

Discussion forum group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Linkoeping University: collaborator

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, D-55122, Germany

Location

Related Publications (4)

• 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.

  PMID: 12271112 BACKGROUND

• 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.

  PMID: 15865915 BACKGROUND

• 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.

  PMID: 17662757 BACKGROUND

• 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.

  PMID: 19027431 BACKGROUND

Related Links

• Study registration website

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolfgang Hiller, Ph.D.

  Johannes Gutenberg University Mainz

  STUDY CHAIR

• Maria Kleinstäuber, Ph.D.

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 21, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 3, 2014

Record last verified: 2014-04

Locations

DE (1)