Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005526

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005526
  •   2014/02/13
  •   2013/08/17
  •   yes
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Secondary IDs

  •   NCT01927991  (ClinicalTrials.gov)
  •   Titus2  (Philipps University Marburg Medical Center)
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Health Condition or Problem studied

  •   Tinnitus
  •   H93.1 -  Tinnitus
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Interventions/Observational Groups

  •   Behavioral: iCBT (internet-based, cognitive-behavioural therapy)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- Change in tinnitus distress; time frame: 1 year; pre, post, 6-mo-follow-up; 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.

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Secondary Outcome

- Change in depressive Symptoms; time frame: 1 year; pre, post, 6mo-follow-up; 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; time frame: 1 year; pre, post, 6mo-follow-up; 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; time frame: 1 year; pre, post, 6mo-follow-up; 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/09/30
  •   100
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- tinnitus duration of more than 6 months

- severe or most severe tinnitus distress

- age of at least 18 years

- fluent in German

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Exclusion Criteria

- psychosis, severe psychological disorder, risk for suicide

- prior participation in associated study

- medical disorder as reason for tinnitus, i.e. morbus ménière

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Addresses

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    • Philipps University Marburg Medical Center
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    • Linköping University, Dept. of Behavioural Sciences and Learning
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    • Philipps-University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
    • Cornelia Weise, Dr. 
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    • Cornelia Weise, Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.