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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Linköping University, Dept. of Behavioural Sciences and Learning
Information provided by (Responsible Party):
Cornelia Weise, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01927991
First received: August 17, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Tinnitus
Behavioral: iCBT (internet-based, cognitive-behavioural therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-based Self-help for Tinnitus: The Role of Support

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Change in tinnitus distress [ Time Frame: 1 year; pre, post, 6-mo-follow-up ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Change in depressive Symptoms [ Time Frame: 1 year; pre, post, 6mo-follow-up ] [ Designated as safety issue: No ]

    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.


  • Change in tinnitus-related thoughts [ Time Frame: 1 year; pre, post, 6mo-follow-up ] [ Designated as safety issue: No ]

    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.


  • Change of tinnitus acceptance [ Time Frame: 1 year; pre, post, 6mo-follow-up ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Screening of psychiatric symptoms [ Time Frame: Pre-Treatment ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927991

Locations
Germany
Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
Marburg, Hessen, Germany, 35037
Sponsors and Collaborators
Philipps University Marburg Medical Center
Linköping University, Dept. of Behavioural Sciences and Learning
Investigators
Principal Investigator: Cornelia Weise, Dr. Philipps-University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
  More Information

No publications provided

Responsible Party: Cornelia Weise, Dr. rer. nat., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01927991     History of Changes
Other Study ID Numbers: Titus2
Study First Received: August 17, 2013
Last Updated: December 9, 2013
Health Authority: Germany: Department of Psychology, Division of Clinical Psychology

Keywords provided by Philipps University Marburg Medical Center:
tinnitus
cognitive behavioural therapy
internet treatment

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014