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Completed

NCT Number: NCT01927991

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy

Marburg, Hesse, 35037, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iCBT (internet-based, cognitive-behavioural therapy)

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • Linkoeping University

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 23, 2013
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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