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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCBT with therapeutic support | Experimental | Participants work with the online self-help and receive additional therapeutic support on demand |
|
| iCBT without therapeutic support | Active Comparator | Participants work with the online self-help on their own and do not receive additional therapeutic support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia Weise, Dr. | Philipps-University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy | Marburg | Hesse | 35037 | Germany |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |