Kröner‐Herwig 2003.
| Methods | Randomised controlled trial. Randomisation by drawing code numbers from the total sample and the sequential assignment to the treatment conditions until a pre‐set number of subjects was reached. | |
| Participants | 95 (of 116 initially recruited) patients (51.6% female, mean age 46.8 years) allocated to 4 groups Inclusion criteria were: (1) Age between 18 and 65 years (2) Duration of tinnitus more than 6 months (3) Medical diagnosis of 'idiopathic' (unknown) tinnitus (4) Tinnitus being their main health problem, with subjective annoyance rating of > 40 (out 100) on 9 scales assessing disruptive effects of tinnitus Exclusion criteria were: (1) Ménière's disease (2) Hearing loss preventing from participating in communication within groups (3) Current psychotherapeutic treatment |
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| Interventions | Four experimental groups:
(1) Tinnitus Coping Training (TCT = 43 patients)
(2) 'Minimal contact ‐ education' (MC‐E = 16 patients)
(3) Minimal Contact ‐ Relaxation (MC‐R = 16 patients)
(4) A waiting list control (WLC = 20 patients) TCT comprised 11 sessions of 90 to 120 minutes duration, each group consisted of 6 to 8 patients and was conducted by 2 qualified psychologists MC‐E comprised of 2 group sessions (of education and self‐help strategies for coping with tinnitus) 4 weeks apart while 'self‐help exercises' were undertaken MC‐R consisted of an educational session in relaxation and distraction, followed by a second session were patients received audio cassettes with relaxing music and instructions, then a further 2 sessions to discuss progress. Patients in MC‐E and MC‐R were told they could join in TCT after post‐treatment assessment. All assessments were completed at pre‐treatment, post‐treatment 6 and 12 months follow up |
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| Outcomes | The outcome measures included: (1) Self‐monitoring tinnitus diary (during 2 weeks period at pre‐, post‐treatment and 6 months follow up): loudness, tinnitus awareness and subjective control of tinnitus (2) Psychometric questionnaires: TQ (only instrument used at 12‐month follow up), TDQ , a German coping inventory (COPE), SCL‐90R and a German depression scale (ADS), a questionnaire of subjective change in tinnitus‐related variables (loudness, disability, awareness, control, ignoring) and general well‐being variables: physical well‐being, activities, mood and stress coping). All assessments were completed at pre‐treatment, post‐treatment and 6 months follow up, Tinnitus Questionnaire was the only assessment used at 12 months follow up (3) Audiological variables (tinnitus masking level, tinnitus sensation level) are only measured in the pre‐treatment period | |
| Notes | The number of patients lost was 21 (13 in the TCT group, 4 in MC‐E and MC‐R each). Total drop‐out = 21/95 = 22.1%. There were no adverse effects reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |