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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927991
• Other study ID #: Titus2
• Status: Completed
• Phase: N/A
• First received: August 17, 2013
• Last updated: April 27, 2015
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Department of Psychology, Division of Clinical Psychology
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.

Locations

Country	Name	City	State
Germany	Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy	Marburg	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Linkoeping University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Screening of psychiatric symptoms	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	No
Primary	Change in tinnitus distress	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	No
Secondary	Change in depressive Symptoms	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	No
Secondary	Change in tinnitus-related thoughts	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	No
Secondary	Change of tinnitus acceptance	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	No