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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tinnitus

Intervention / Treatment
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* Behavioral: iCBT (internet-based, cognitive-behavioural therapy)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCBT with therapeutic support<br>Participants work with the online self-help and receive additional therapeutic support on demand | Behavioral: iCBT (internet-based, cognitive-behavioural therapy)<br>* 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.<br>|
| Active Comparator: iCBT without therapeutic support<br>Participants work with the online self-help on their own and do not receive additional therapeutic support | Behavioral: iCBT (internet-based, cognitive-behavioural therapy)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, cognitive behavioural therapy, internet treatment