Background: A significant proportion of patients with chronic tinnitus report clinical levels of sleep disturbance (insomnia). Despite the significant health and functioning implications of this, no rigorous trials have investigated treatments that target tinnitus-related insomnia. This is the first randomised controlled trial evaluating Cognitive Behavioural Therapy for insomnia (CBTi) in tinnitus compared with other psychological treatments.
Methods/design: The study will test the efficacy of group CBTi as a treatment for tinnitus-related insomnia in a single-centre randomised controlled trial. Participants will be 102 patients with chronic, clinically significant tinnitus and insomnia in the absence of organic sleep disorders. Participants will be randomised to one of three intervention arms: six sessions of CBTi or six sessions of sleep support group or two sessions of audiologically based care. The primary outcomes will be changes in sleep as measured on the Insomnia Severity Index and key outcomes on a 2-week sleep diary (sleep efficiency and total sleep time). Outcomes will be collected 3, 10, 14 and 34 weeks post-randomisation. Secondary measures include sleep quality, sleep beliefs, tinnitus severity, psychological distress and quality of life. A sub-sample of participants will provide two weeks of actigraphy data at the same time points. Data on satisfaction and treatment experience will be collected at 10 and 34 weeks post-randomisation from all participants.
Discussion: Findings from the study will be submitted to a peer-reviewed journal. It is anticipated that findings may inform future clinical practice in the treatment of tinnitus-related insomnia.
Trial registration: ClinicalTrials.gov, NCT03386123. Retrospectively registered on 29 December 2017.
Keywords: CBT; Cognitive behavioural therapy; Insomnia; Support groups; Tinnitus.