Weise 2008.

Methods	Randomised controlled trial
Participants	111 (of 130 initially recruited) patients allocated to 2 groups: treatment group (44.2% female, mean age 49.46 years) and waiting list group (44.1% female, mean age 52.93 years) Inclusion criteria were: (1) Duration of tinnitus greater than 6 months (2) Serious or severe tinnitus annoyance (TQ score = 47 or more) (3) Between 16 and 75 years of age Exclusion criteria were: (1) Mild degree of tinnitus annoyance (2) Tinnitus following Ménière's disease (3) Patients with psychosis or seriously disabling brain damage
Interventions	Two experimental groups: (1) Biofeedback‐based behavioural intervention (52 patients) (2) A waiting list control (59 patients) The biofeedback‐based behavioural intervention consisted of 12 individual therapy sessions of 60 minutes duration conducted by 4 trained therapists. Each session contained biofeedback as well as CBT elements following a structured manual.
Outcomes	The outcome measures included: (1) Global tinnitus annoyance measured with TQ (2) Tinnitus diary (for 1 week at each assessment point) on a Visual Analogue Scale (0 to 10) including: subjective loudness, sleep disturbance, impairment, distress due to tinnitus and feelings of controllability (3) Psychometric questionnaires: BDI, SCL‐90‐R, GSI, TRSS, TRCS All assessments were completed at pre‐treatment, post‐treatment and 6 months follow up
Notes	Total drop‐out at post‐treatment measurement = 19/130 = 14.61%. Results for the adverse effects subscale (M = 1.51; SD = 0.63; range 1 to 6) indicated that the majority of the patients did not experience negative side effects caused by the treatment. Results for the satisfaction with therapy subscale (M = 5.16, SD = 0.51; range 1 to 6) indicated that patients were quite content with the treatment.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	Randomisation using a computer‐generated random list