Background: The aim of this randomized controlled trial was to investigate the effects of conventional face-to-face group cognitive behavioral therapy (GCBT) and an Internet-delivered guided self-help treatment (Internet-based CBT, ICBT) on tinnitus distress. Methods: A total of 128 adults with at least mild levels of chronic tinnitus distress were randomly assigned to GCBT (n = 43), ICBT (n = 41), or a web-based discussion forum (DF) that served as a control condition (n = 44). Standardized self-report measures [the Tinnitus Handicap Inventory (THI), Mini-Tinnitus Questionnaire (Mini-TQ), Hospital Anxiety and Depression Scale, Insomnia Severity Index and Tinnitus Acceptance Questionnaire] were completed at the pre- and post-assessments and at the 6-month follow-up. Results: Repeated-measures ANOVAs revealed significant time × group interaction effects on the primary outcomes (THI and Mini-TQ scores) in favor of both CBT interventions compared with the DF at post-assessment (0.56 ≤ g ≤ 0.93; all p ≤ 0.001). There were no significant differences between GCBT and ICBT (all p > 0.05) and the treatment effects remained stable at the 6-month follow-up. Conclusions: This study provides evidence that ICBT might be an equally effective alternative to conventional CBT in the management of chronic tinnitus. Despite encouraging results, further research is necessary to determine the actual potential of ICBT as a viable alternative to CBT, and under which circumstances it is effective.
Background and Purpose-Strokes have especially devastating implications if they occur early in life; however, only limited information exists on the characteristics of acute cerebrovascular disease in young adults. Although risk factors and manifestation of atherosclerosis are commonly associated with stroke in the elderly, recent data suggests different causes for stroke in the young. We initiated the prospective, multinational European study Stroke in Young Fabry Patients (sifap) to characterize a cohort of young stroke patients. Methods-Overall, 5023 patients aged 18 to 55 years with the diagnosis of ischemic stroke (3396) *Drs Rolfs, Fazekas and Grittner contributed equally to this work. Authors contributions: Dr Rolfs has conceptualized, initiated, and designed and organized the study, has been involved in the recruitment of the patients, and wrote significant parts of the manuscript. Dr Fazekas was involved in the study planning and has done together with Drs Enzinger and Schmidt the analysis of all MRI scans; this group was mainly involved in the statistical analysis of the MRI data. Drs Martus, Grittner, Holzhausen have taken responsibility for all statistical analysis and for the data structure of the total data bank. Drs Dichgans, Böttcher, Tatlisumak, Tanislav, Jungehulsing, Putaala, Huber, Bodechtel, Lichy, Hennerici, Kaps, Meyer, Kessler have been most active in the recruitment of the patients, drafting the manuscript and significantly influencing the scientific discussion. Dr Heuschmann was involved in drafting the manuscript and influencing the scientific discussion. Dr Norrving chaired the steering and publication committees of sifap, has written parts of the manuscript, and has significantly influenced the scientific discussions. Drs Lackner and Paschke, H. Mascher, Dr Riess have been involved in the laboratory analyses. Dr Kolodny has mostly contributed to the discussion of the Fabry cases. Dr Giese assisted in writing and editing the manuscript. All authors have reviewed, critically revised and approved the final version of the manuscript.The sponsors of the study had no role in the study design, data collection, data analysis, interpretation, writing of the manuscript, or the decision to submit the manuscript for publication. The academic authors had unrestricted access to the derived dataset, and assume full responsibility for the completeness, integrity, and interpretation of the data, as well as writing the study report and the decision to submit for publication.†Listed in Appendix I in the online-only Data Supplement. Jeffrey L. Saver, MD, was guest editor for this article.
ClinicalTrials.gov, Identifier: NCT01205919.
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