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

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Behavioral: iCBT (internet-based, cognitive-behavioural therapy)

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Marburg, Hessen, Germany, 35037
      • Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iCBT with therapeutic support; Participants work with the online self-help and receive additional therapeutic support on demand	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.
Active Comparator: iCBT without therapeutic support; Participants work with the online self-help on their own and do not receive additional therapeutic support	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Collaborators: Linkoeping University
• Investigators: Principal Investigator: Cornelia Weise, Dr., Philipps-University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 17, 2013
• First Submitted That Met QC Criteria: August 20, 2013
• First Posted (Estimate): August 23, 2013

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: tinnitus; cognitive behavioural therapy; internet treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: Titus2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No