Internet-based Self-help for Tinnitus: The Role of Support

April 27, 2015 updated by: Cornelia Weise, Philipps University Marburg Medical Center
Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to provide psychotherapy. For several psychological and psychosomatic disorders, treatment efficacy was shown. Previously, iCBT has also been applied to patients suffering from tinnitus and results show significant and long-term stable improvements in tinnitus distress. However, the role of therapeutic support in iCBT has not been thoroughly investigated. Previous results suggest that iCBT without therapeutic support is less effective and leads to higher dropout rates than therapist-guided iCBT. The aim of the randomized controlled trial is thus to investigate the role of therapeutic support in an iCBT for tinnitus sufferers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

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
    • Hessen
      • Marburg, Hessen, Germany, 35037
        • Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy

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:

  • tinnitus duration of more than 6 months
  • severe or most severe tinnitus distress
  • age of at least 18 years
  • fluent in German

Exclusion Criteria:

  • psychosis, severe psychological disorder, risk for suicide
  • prior participation in associated study
  • medical disorder as reason for tinnitus, i.e. morbus ménière

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iCBT with therapeutic support
Participants work with the online self-help and receive additional therapeutic support on demand
Behavioral: iCBT (internet-based, cognitive-behavioural therapy)
The intervention is based on cognitive-behavioural therapy (CBT) and is offered as a self-help and provided over the internet. Participants work on their own on different modules which give information about tinnitus and the associated symptoms and provide instructions for practical exercises.
Active Comparator: iCBT without therapeutic support
Participants work with the online self-help on their own and do not receive additional therapeutic support
Behavioral: iCBT (internet-based, cognitive-behavioural therapy)
The intervention is based on cognitive-behavioural therapy (CBT) and is offered as a self-help and provided over the internet. Participants work on their own on different modules which give information about tinnitus and the associated symptoms and provide instructions for practical exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tinnitus distress
Time Frame: 1 year; pre, post, 6-mo-follow-up

Assessment of tinnitus distress with the Tinnitus Handicap Inventory (THI) and the Mini-Tinnitus Questionnaire (Mini-TQ)

Newman, C. W., Jacobson, G. P., & Spitzer, J. B. (1996). Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg, 122(2), 143-148.

Hiller, W., & Goebel, G. (2004). Rapid assessment of tinnitus-related psychological distress using the Mini-TQ. Int J Audiol, 43(10), 600-604.
1 year; pre, post, 6-mo-follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive Symptoms
Time Frame: 1 year; pre, post, 6mo-follow-up

Assessment of depressive symptoms with the Patient Health Questionnaire (PHQ-9) and the Hospital Anxiety and Depression Scale (HADS)

Kroenke, K., Spitzer, R. L., & Williams, J. B. W. (2001). The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med, 16(9), 606-613. 10.1046/j.1525-1497.2001.016009606.x

Zigmond, A. S., & Snaith, R. P. (1983). The hospital anxiety and depression scale. Acta Psychiatr Scand, 67(6), 361-370.
1 year; pre, post, 6mo-follow-up
Change in tinnitus-related thoughts
Time Frame: 1 year; pre, post, 6mo-follow-up

Assessment of dysfunctional tinnitus-related thoughts with the Tinnitus Cognitions Scale (T-Cog)

Hiller, W., & Haerkötter, C. (2005). Does sound stimulation have additive effects on cognitive-behavioral treatment of chronic tinnitus? Behav Res Ther, 43(5), 595-612.
1 year; pre, post, 6mo-follow-up
Change of tinnitus acceptance
Time Frame: 1 year; pre, post, 6mo-follow-up

Assessment of tinnitus acceptance with the Tinnitus Acceptance Questionnaire (TAQ)

Weise, C., Kleinstauber, M., Hesser, H., Westin, V. Z., & Andersson, G. (2013). Acceptance of tinnitus: validation of the tinnitus acceptance questionnaire. Cognitive Behaviour Therapy, 42(2), 100-115. 10.1080/16506073.2013.781670
1 year; pre, post, 6mo-follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening of psychiatric symptoms
Time Frame: Pre-Treatment

Assessment of psychiatric disorders at pre-treatment

Donker, T., van Straten, A., Marks, I., & Cuijpers, P. (2009). A Brief Web-Based Screening Questionnaire for Common Mental Disorders: Development and Validation. Journal of Medical Internet Research, 11(3), Artn E19. Doi 10.2196/Jmir.1134
Pre-Treatment

Collaborators and Investigators

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

Sponsor

Philipps University Marburg Medical Center

Collaborators

Linkoeping University

Investigators

  • Principal Investigator: Cornelia Weise, Dr., Philipps-University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy

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

September 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

August 17, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (Estimate)

August 23, 2013

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Titus2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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