Internet-based Self-help for Tinnitus: The Role of Support
Primary Purpose
Tinnitus
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
iCBT (internet-based, cognitive-behavioural therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, cognitive behavioural therapy, internet treatment
Eligibility 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
Sites / Locations
- Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
iCBT with therapeutic support
iCBT without therapeutic support
Arm Description
Participants work with the online self-help and receive additional therapeutic support on demand
Participants work with the online self-help on their own and do not receive additional therapeutic support
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
Full Information
NCT ID
NCT01927991
First Posted
August 17, 2013
Last Updated
April 27, 2015
Sponsor
Philipps University Marburg Medical Center
Collaborators
Linkoeping University
1. Study Identification
Unique Protocol Identification Number
NCT01927991
Brief Title
Internet-based Self-help for Tinnitus: The Role of Support
Official Title
Internet-based Self-help for Tinnitus: The Role of Support
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
Linkoeping University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, cognitive behavioural therapy, internet treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iCBT with therapeutic support
Arm Type
Experimental
Arm Description
Participants work with the online self-help and receive additional therapeutic support on demand
Arm Title
iCBT without therapeutic support
Arm Type
Active Comparator
Arm Description
Participants work with the online self-help on their own and do not receive additional therapeutic support
Intervention Type
Behavioral
Intervention Name(s)
iCBT (internet-based, cognitive-behavioural therapy)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in tinnitus distress
Description
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.
Time Frame
1 year; pre, post, 6-mo-follow-up
Secondary Outcome Measure Information:
Title
Change in depressive Symptoms
Description
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.
Time Frame
1 year; pre, post, 6mo-follow-up
Title
Change in tinnitus-related thoughts
Description
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.
Time Frame
1 year; pre, post, 6mo-follow-up
Title
Change of tinnitus acceptance
Description
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
Time Frame
1 year; pre, post, 6mo-follow-up
Other Pre-specified Outcome Measures:
Title
Screening of psychiatric symptoms
Description
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
Time Frame
Pre-Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia Weise, Dr.
Organizational Affiliation
Philipps-University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany
12. IPD Sharing Statement
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Internet-based Self-help for Tinnitus: The Role of Support
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