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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01927991
Enrollment
112
Registered
2013-08-23
Start date
2012-09-30
Completion date
2014-05-31
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Keywords

tinnitus, cognitive behavioural therapy, internet treatment

Brief 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.

Interventions

BEHAVIORALiCBT (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.

Sponsors

Linkoeping University
CollaboratorOTHER_GOV
Philipps University Marburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in tinnitus distress1 year; pre, post, 6-mo-follow-upAssessment 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

MeasureTime frameDescription
Change in depressive Symptoms1 year; pre, post, 6mo-follow-upAssessment 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 thoughts1 year; pre, post, 6mo-follow-upAssessment 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 acceptance1 year; pre, post, 6mo-follow-upAssessment 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

MeasureTime frameDescription
Screening of psychiatric symptomsPre-TreatmentAssessment 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026